• Independent Data Monitoring Committee authorized proceeding to Phase 2 at highest dose level tested following review of clinical safety data from the Phase 1 dose escalation
• Phase 2 clinical data readouts on safety and efficacy of XC001 anticipated in 2022
• Company plans to commence study startup of XC001 as an adjunct to CABG in 2H21, and clinical studies in additional cardiovascular indications are under discussion
• Progress highlights potential of gene therapy in cardiovascular disease

Wayne, PA, July 27, 2021 – XyloCor Therapeutics, a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced the completion of the Phase 1 dose-escalation component of its Phase 1/2 clinical trial (EXACT) of XC001 (encoberminogene rezmadenovec), its lead investigational gene therapy candidate for patients with refractory angina who have no further treatment options.

Following a review of clinical data from the Phase 1 dose escalation component of the study, the Independent Data Monitoring Committee (IDMC) authorized proceeding to the Phase 2 component of the study at the highest dose tested. Since the IDMC authorization, three patients have been dosed in the Phase 2 expansion cohort. This progress highlights the potential for gene therapy to go beyond rare diseases and to address larger patient populations with significant unmet needs, such as chronic cardiovascular diseases. 

XyloCor also confirms that it plans to submit an additional Phase 2 clinical study to the U.S. Food and Drug Administration (FDA) for XC001 as adjunctive therapy to coronary artery bypass grafting (CABG) in 2H21. The company also plans other clinical studies in additional cardiovascular indications, including heart failure caused by ischemic heart disease and as adjunctive therapy to percutaneous coronary intervention.

“Patients with refractory angina are forced to live with the ongoing burden of a disease that limits their activities on a daily basis due to chest pain,” said Thomas Povsic, M.D., Ph.D., Duke University cardiologist and National Principal Investigator for the EXACT study. “With a unique mechanism of action that restores blood flow to the heart via the creation of new blood vessels, XC001 represents a novel therapeutic approach for patients who have exhausted other medical and surgical options. It is very exciting to now move forward with exploring XC001’s potential in the Phase 2 portion of EXACT as a one-time therapy for patients with refractory angina.”

“In our mission to deliver safe and effective gene therapies that transform the lives of people with cardiovascular disease, we are excited to achieve this important milestone and advance into the Phase 2 portion of our study,” said Al Gianchetti, President and Chief Executive Officer of XyloCor Therapeutics. “XC001 has enormous potential to significantly improve the lives of patients with refractory angina. We are grateful for the support of patients and their families, as well as the EXACT trial investigators as we continue to study the safety and efficacy of XC001 and look forward to reporting results in 2022.”

About XC001

XC001 (encoberminogene rezmadenovec) is a novel, investigational gene therapy designed to stimulate the growth of new blood vessels in the heart, in order to bypass diseased vessels and improve coronary blood flow. XC001 delivers the gene for vascular endothelial growth factor (VEGF), a naturally occurring protein, in targeted myocardial cells, thus stimulating the creation of new blood vessels via a process called angiogenesis. XC001 employs a proprietary multi-isoform VEGF expression cassette that has been optimized to maximize expression of VEGF. XC001 has been granted Fast Track designation by the FDA for study in refractory angina. XyloCor commenced the EXACT Trial, a Phase 1/2 study of XC001 in chronic refractory angina, in 2020.

About the EXACT Study

The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial is a Phase 1/2 multicenter, open-label, single-arm, dose-escalation trial. 12 subjects (n=3 per dose cohort) who have refractory angina were enrolled into four ascending dose groups, to be followed by an expansion phase of the trial with 21 additional subjects at the highest tolerated dose. The trial is designed to assess the preliminary safety and efficacy of XC001. The investigational gene therapy is administered directly to the heart muscle through a mini-thoracotomy by an experienced cardiac surgeon. The EXACT Trial is being conducted at top cardiovascular research sites across the United States.

About Chronic Refractory Angina

In the United States, coronary artery disease is a leading cause of death and disability. Chronic angina pectoris occurs when the heart muscle does not receive sufficient oxygen resulting in chest pain. This is usually due to atherosclerotic plaques that block the coronary arteries. Refractory angina is a growing problem that occurs in patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). These patients currently have no treatment options and are frequently highly symptomatic, which severely impacts their quality of life, and may exacerbate comorbidities and cause further deterioration of their health status.  Refractory angina results in significant consumption of healthcare resources, including visits to the emergency department as a result of patients’ chest pain. An estimated one million people suffer from refractory angina in the United States.

About XyloCor

XyloCor Therapeutics is a private, clinical-stage biopharmaceutical company developing potential best-in-class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co-founded by Ronald Crystal, MD, and Todd Rosengart, MD, has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

# # #

Media Contact:

Mike Beyer

Sam Brown Inc.

mikebeyer@sambrown.com

312-961-2502

HistoSonics, the developer and manufacturer of a non-invasive platform and novel sonic beam therapy called histotripsy, today announced that the American Medical Association (AMA) has issued a new Current Procedural Terminology (CPT) code for histotripsy of the liver. Histotripsy of the liver provides clinicians the first automated external beam therapy using acoustic energy to mechanically destroy tissue in the liver without incisions, ionizing radiation or heat. The new CPT code will become effective on January 1, 2022, at which time providers can utilize the code when performing histotripsy procedures on patients across the United States. 

CPT codes are granted and regulated by the AMA CPT Editorial Panel and are widely used by government payers, including Medicare and Medicaid, and commercial health plans to describe healthcare services and procedures for reimbursement. The release of this new code represents a major reimbursement milestone as hospitals across the US will be able to submit claims directly related to the service. Ultimately, this new code will provide patients and physicians access to histotripsy as an option to treat liver tissue non-invasively and without potential complications seen with conventional therapies like bleeding, infection, or pain from surgery.

HistoSonics’ non-invasive platform combines advanced imaging and proprietary software to deliver patient specific treatments and uses the science of histotripsy to mechanically destroy targeted tissues at sub-cellular levels. The company believes that the novel mechanism of action of their proprietary technology, intended to avoid thermal necrosis and ionizing radiation, may provide significant advantages to patients, including the ability of the treatment site to recover and resolve quickly, as well as provides physicians the unique ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today. “This is an important reimbursement milestone for providers who will utilize this new therapy option for their patients,” commented Mike Blue, President and CEO of HistoSonics. “This specific CPT code will enable data collection of the use of histotripsy procedures and facilitate reimbursement with payers to enable broad access for the many patients who could potentially benefit from histotripsy’s unique capabilities.”

The new Category III CPT code, 0686T Histotripsy (ie, non-thermal ablation via acoustic energy delivery) of malignant hepatocellular tissue, including image guidance will become effective January 1, 2022.

Only 20%-30% of patients with liver tumors are eligible for surgical resection due to the presence of multiple tumors, underlying poor liver function, or general health issues limiting the success of surgery.  Primary liver tumors were the third leading cause of tumor related death worldwide in 2020, with approximately 906,000 new cases and 830,000 deaths globally, and 5-year survival rates less than 18%.  Additionally, the liver is second only to lymph nodes as the most common site of metastatic tumors, those that spread from other organs, and estimated to be present in up-to 70% of patients with advanced disease from another site.  Histotripsy may provide benefits to these patients due to its unique non-invasive, non-thermal, and non-ionizing destructive capabilities. 

The HistoSonics device is investigational and is not available for sale in the United States or Europe. It is limited to investigational use in the approved IDE and European studies.

About HistoSonics

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors.  The company is currently focused on the continued development of its Edison^TM Platform, global clinical studies, and new strategic projects including future clinical applications and platforms. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.

For more information please visit: www.histosonics.com/

SOURCE HistoSonics, Inc.

Related Links

www.histosonics.com

Antios Therapeutics, Inc. and Arbutus Biopharma Corporation (Nasdaq: ABUS) today announced that the companies have entered into a clinical collaboration agreement to evaluate a triple combination of Arbutus’ proprietary GalNAc delivered RNAi therapeutic, AB-729, Antios’ proprietary active site polymerase inhibitor nucleotide (ASPIN), ATI-2173, and Viread (tenofovir disoproxil fumarate), for the treatment of subjects with chronic hepatitis B virus (HBV) infection.

ATI-2173, AB-729 and Viread will be evaluated in combination in a single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial.  The multi-center, double-blinded, placebo-controlled, multiple‑dose cohort will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of the combination of ATI-2173, AB-729 and Viread.  This cohort is expected to initiate in the second half of 2021.  Antios will be responsible for the costs of adding this single cohort to its ongoing clinical trial. Arbutus will be responsible for the manufacture and supply of AB-729.

“This collaboration with Antios advances our efforts to position AB-729 as a potential cornerstone therapeutic in future HBV combination regimens and reflects our conviction that a combination of agents with complementary mechanisms of action is needed to cure chronic HBV,” stated William Collier, Chief Executive Officer at Arbutus.”

Greg Mayes, Chief Executive Officer of Antios said, “ATI-2173 has, to date, demonstrated a well-tolerated safety profile and sustained on- and off-treatment antiviral responses as a monotherapy in patients with chronic HBV. We believe that its unique mechanism of action and early evidence of clinical activity may position ATI-2173 as the backbone of a once-daily curative regimen in combination with other agents for chronic HBV. Our collaboration with Arbutus will test that hypothesis in combination with AB-729, an RNAi drug candidate, and Viread, a nucleotide analogue.”

About the Combination Clinical Trial Cohort

The combination clinical trial cohort will include 10 subjects with chronic HBV infection assigned 8:2 to active drug (ATI-2173+AB-729) or matching placebos. The active drug (ATI-2173+AB-729) or placebo will be administered in combination with 300 mg of Viread (equivalent to 245 mg of tenofovir disoproxil fumarate). ATI-2173 and Viread will be administered once a day for 90 days.  AB-729 will be administered by subcutaneous injection at Day 28 and Day 90.  Following this 90 day treatment period, subjects will be followed-up for safety and sustained antiviral responses for 6 additional months.

Any subjects whose HBV DNA remains below the limit of quantification (BLQ) at 6 months of follow-up will have HBV DNA and virology samples collected every 3 months off therapy until a detectable HBV DNA level is confirmed, or until 18 months after the 6 months of follow-up, whichever comes first.

About AB-729

AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Based upon clinical data generated thus far in an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 has demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

About ATI-2173

ATI-2173 is a novel, orally-administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) molecule designed to deliver the 5’-monophosphate of clevudine to the liver. This L-nucleoside’s active 5’-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor that distorts the active site of HBV polymerase resulting in potent HBV antiviral activity and extended off-treatment suppression of HBV DNA. ATI-2173 targets the liver, delivering high levels of the unique 5’- triphosphate while limiting systemic exposure to the parent L-nucleoside. ATI-2173 has the potential to become an integral part of a curative combination regimen for chronic hepatitis B.

About HBV

Hepatitis B is a potentially life-threatening liver infection caused by HBV. HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection (CHB) represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 900,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.

About Arbutus

Arbutus Biopharma Corporation is a publicly traded (Nasdaq: ABUS) biopharmaceutical company primarily focused on discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple product candidates with distinct mechanisms of action that it believes have the potential to provide a new curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19).  For more information, visit www.arbutusbio.com.

About Antios

Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Antios is currently developing ATI-2173, aiming to provide chronic hepatitis B-infected patients with a curative combination regimen.

Arbutus Forward-Looking Statements and Information

This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include statements about our expectations for the collaboration; the timing and expected trial design of the Phase 2a clinical trial to be initiated by the parties pursuant to the agreement; and Arbutus’ belief that AB-729 has the potential to become a cornerstone therapeutic in multiple future HBV combination regimens.

With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing COVID-19 pandemic.

Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: the parties may never realize the expected benefits of the collaboration; anticipated clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; economic and market conditions may worsen; market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt clinical development programs.

A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

Arbutus Contact Information

Investors and Media

William H. Collier
President and CEO
Phone: 267-469-0914
Email: ir@arbutusbio.com

Pam Murphy
Investor Relations Consultant
Phone: 267-469-0914
Email: ir@arbutusbio.com

Antios Contact Information

Investors:
Lee Roth
Burns McClellan
lroth@burnsmc.com
+1 (212) 300-8331

Media:
Ryo Imai / Robert Flamm, PhD
Burns McClellan
rimai@burnsmc.com / rflamm@burnsmc.com
+1 (212) 300-8315 / +1 (212) 300-8364

Product candidate FPI-1434, administered at three different dose levels, demonstrated a favorable safety profile with no drug-related serious adverse events or dose-limiting toxicity

Imaging shows drug uptake across multiple tumor types

Enrollment in multi-dosing cohorts continues

Fusion also reported preclinical data showing the combination of FPI-1434 with olaparib resulting in synergistic efficacy against colorectal and lung cancer xenografts, and combination with immune checkpoint inhibitors demonstrated enhanced efficacy in colorectal cancer models

Data featured in oral sessions and posters at the SNMMI 2021 Virtual Annual Meeting

HAMILTON, Ontario and BOSTON, June 14, 2021: Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Virtual Annual Meeting. The presentations and posters highlight the potential of Fusion’s targeted alpha therapies (TATs) to enable delivery of alpha particle emitting isotopes (²²⁵Ac) to targeted tumor cells.

“The data from our ongoing clinical study of FPI-1434 presented at SNMMI demonstrated that treatment with our actinium-based targeted alpha therapy was well tolerated, and imaging shows uptake of the drug across multiple tumor types,” said Chief Executive Officer John Valliant, Ph.D. “Importantly, these data supported our ability to initiate the multi-dosing portion of the study, in which we would expect to begin reaching total cumulative levels of radiation necessary to demonstrate anti-tumor activity.”

In both the oral session and the poster titled, “Preliminary Dosimetry Results from a First-in-Human Phase 1 Study Evaluating the Efficacy and Safety of [²²⁵Ac]-FPI-1434 in Patients with IGF-1R Expressing Solid Tumors,” results from the first three patient cohorts (n=12) demonstrated a favorable safety profile for [²²⁵Ac]-FPI-1434. No drug-related serious adverse events and/or dose limiting toxicity were reported in administered activity up to 40 kBq/kg body weight and dosimetric results were within normal organ radiation tolerability limits. The single dose escalation portion of the study has concluded, while enrollment into the multi-dosing cohorts are ongoing.

Preclinical Results Combining FPI-1434 with DNA Damage Response Inhibitor (DDRi) and Immune Checkpoint Inhibitors
In separate oral and poster presentations, Fusion presented preclinical data demonstrating synergistic efficacy against olaparib-resistant colorectal and radioresistant lung cancer xenografts when combining FPI-1434 with olaparib.

The combination of the two therapeutics, using doses that were non-effective as single agents, resulted in anti-tumor efficacy against colorectal and non-small cell lung cancer tumor models. The strongest combination effect appeared to occur at the lowest single agent doses, as FPI-1434’s efficacy dominated at higher dose levels.

Fusion also presented preclinical data showing that treatment with FPI-1434 in combination with immune checkpoint inhibitors resulted in complete tumor eradication. Additionally, an increase in antigen-specific CD8 positive T cells and a strong “vaccine” effect were observed with the combination of IGF-1R TAT and immune checkpoint inhibitors, as noted by the prevention of tumor growth in animals that were reinoculated with the same tumor cells.

Dr. Valliant continued, “We are excited by our preclinical data that show the power of combining a potent TAT with the latest generation of cancer therapies, such as checkpoint inhibitors and DDRis. We view these combinations as an opportunity to bring these next-generation radiopharmaceuticals into earlier lines of therapy for patients, and we look forward to initiating combination studies in human once we have achieved the recommended Phase 2 dose for FPI-1434 monotherapy. Our previously announced collaborations with both Merck and AstraZeneca provide us with multiple opportunities to explore these exciting combination therapies.”

Following the conclusion of the SNMMI Annual Meeting, copies of the presentations can be found at https://fusionpharma.com/fusion-scientific-presentations/.

About FPI-1434
FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion’s Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.

About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors.

Fusion’s lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966 targeting the fibroblast growth factor receptor 3 (FGFR3) and FPI-2059, a small molecule recently acquired from Ipsen, targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop up to three novel targeted alpha therapies (TATs) and explore up to five combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion also recently entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (Pembrolizumab) in patients with solid tumors expressing IGF-1R.

Forward Looking Statements
This press release contains “forward-looking statements” for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding Fusion Pharmaceuticals Inc.’s (the “Company”) future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “expect,” “plans,” “anticipates,” “intends,” “will,” and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company’s potential drug candidates, including any expressed or implied statements regarding the successful development of product candidate FPI-1434; and the likelihood of success of any ongoing or future clinical trials involving product candidate FPI-1434. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management’s expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company’s ability to obtain additional funding required to conduct its research, development and commercialization activities; changes in the Company’s business plan or objectives; the ability of the Company to attract and retain qualified personnel; competition in general; and the Company’s ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management’s expectations are described in greater detail under the heading “Risk Factors” in the Company’s quarterly report on Form 10-K for the quarter ended December 31, 2020 as filed with the SEC and in any subsequent periodic or current report that the Company files with the SEC. All forward-looking statements reflect the Company’s estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company’s views, expectations or beliefs at any date subsequent to the date of this release. While Fusion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company’s estimates change.

SOURCE Fusion Pharmaceuticals Inc.

G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the Company has initiated PRESERVE 3, a Phase 2, randomized, open-label study of COSELA™ (trilaciclib) administered with first-line platinum-based chemotherapy and the immune checkpoint inhibitor avelumab maintenance therapy in patients with untreated, locally advanced or metastatic urothelial carcinoma (mUC). Myeloprotection and anti-tumor efficacy endpoints are being assessed in this study. Initial results of this study are expected in the second half of 2022.

“Bladder cancer is unfortunately common and the five-year survival rate for metastatic urothelial carcinoma has not changed in the last 25 years, highlighting the need for new and well tolerated therapies specifically tailored for immune sensitive tumors like this,” said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. “While chemotherapy followed by avelumab maintenance therapy has proven to be a meaningful step forward for the 1L treatment of patients with mUC, patients may not receive the maximal benefit for a variety of reasons. These Phase 2 data will be instructional and important to evaluate the benefit of adding COSELA to this regimen, and if positive, would be quickly followed by a Phase 3 registrational trial.”

Patient recruitment in Preserve 3 is now underway. The study will enroll approximately 90 patients, who will be randomly assigned (1:1) to one of two treatment arms (A or B). Arm A will receive gemcitabine/platinum chemotherapy followed by avelumab maintenance therapy. Arm B will receive COSELA prior to gemcitabine/platinum chemotherapy followed by COSELA plus avelumab maintenance therapy. Standard of care gemcitabine/platinum chemotherapy (with or without the addition of COSELA) will be administered intravenously in 21-day cycles and standard of care avelumab maintenance therapy (with or without the addition of COSELA) will be administered intravenously in 14-day cycles. There will be two stratification factors for randomization: presence of visceral metastasis (yes or no), and initial platinum-based chemotherapy to be administered (cisplatin or carboplatin).

Patients enrolled in the study will be eligible to receive 4 to 6 cycles of platinum-based chemotherapy. Patients without progressive disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines (i.e., with an ongoing complete response, partial response, or stable disease) after platinum-based chemotherapy will be eligible to receive avelumab maintenance therapy (with or without COSELA) until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the trial, whichever occurs first.

The primary endpoint is to evaluate the anti-tumor efficacy of COSELA when combined with platinum-based chemotherapy and the checkpoint inhibitor avelumab maintenance therapy as measured by progression-free survival (PFS) during the overall study. Key secondary endpoints include:

• evaluation of the anti-tumor efficacy of COSELA as measured by the objective response rate (ORR);
• disease control rate;
• duration of objective response (DOR);
• PFS in the maintenance period;
• overall survival (OS) and probability of survival (POS) at Month 16;
• evaluation of the myeloprotective effects of COSELA on chemotherapy-induced myelosuppression; and
• assessment of the safety and tolerability of COSELA in patients receiving platinum-based chemotherapy followed by avelumab maintenance therapy.

G1 announced in February 2021 that it had entered into a clinical trial collaboration with the alliance between Merck KGaA, Darmstadt, Germany and Pfizer whereby the alliance will contribute clinical supply of the checkpoint inhibitor avelumab to this first-line treatment of mUC trial.

About Bladder Cancer
Bladder cancer is the most common malignancy involving the urinary system and is the sixth most common cancer in the United States. The American Cancer Society estimates that approximately 84,000 new cases of bladder cancer will be diagnosed in the U.S. in 2021. Approximately 2.4% of the US population will be diagnosed with bladder cancer at some point during their lifetime; the average age at diagnosis is 73 years and it is rarely diagnosed in people less than 40 years of age. Urothelial carcinoma, also known as transitional cell carcinoma (TCC), urothelial bladder cancer, or urothelial cell carcinoma (UCC) of the urinary tract, is the most common type of bladder cancer in the U.S. and Europe, where it accounts for 90% of all bladder cancers.  It also accounts for up to 15% of kidney cancers diagnosed in adults. The overall 5-year survival rate for metastatic urothelial carcinoma is approximately 5.5%, which has remained unchanged over the past 25 years.

About G1 Therapeutics
G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA™ (trilaciclib). G1 has a deep clinical pipeline and is executing a tumor-agnostic development plan evaluating COSELA in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

G1 Therapeutics™ and the G1 Therapeutics logo and COSELA™ and the COSELA logo are trademarks of G1 Therapeutics, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, COSELA’s (trilaciclib) possibility to improve patient outcomes in this Phase 2 trial of COSELA in bladder cancer, the stated primary and secondary endpoints may not achieve statistical significance, delays in the enrollment of patients in this trial of COSELA may delay or prevent our plans, COSELA may fail to achieve the degree of market acceptance for commercial success, and are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the company’s dependence on the commercial success of COSELA; the development and commercialization of new drug products is highly competitive; the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:

Will Roberts
G1 Therapeutics, Inc.
Vice President
Investor Relations and Corporate Communications
(919) 907-1944
wroberts@g1therapeutics.com

HAMILTON, ON and BOSTON, June 7, 2021: Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the appointment of Isabelle Dussault, Ph.D. as senior vice president, research.

“Isabelle brings deep oncology research experience, including antibody-drug conjugate, biomarker and immuno-oncology expertise, to our team and we are pleased to welcome her,” said Chief Executive Officer John Valliant, Ph.D. “Fusion’s research capabilities are a core pillar of our platform. We look forward to Isabelle’s contributions to expanding our pipeline of radiopharmaceuticals in early development and continuing to grow and leverage our leadership in understanding the biology of targeted alpha therapies.”

Dr. Dussault was most recently global head of clinical biomarker strategy at EMD Serono, a subsidiary of Merck KGaA, where she oversaw clinical biomarker strategy for the entire portfolio. Prior to that, she was director of oncology research, tumor micro-environment and immuno-oncology at Bristol-Myers Squibb following her role as a director of oncology research for Merck and Amgen. Dr. Dussault holds Ph.D. and B.Sc. degrees from McGill University.

Inducement Equity Awards

Fusion’s Compensation Committee of the Board of Directors approved a grant of stock options to Dr. Dussault to purchase 132,000 of Fusion’s common shares. Each option was granted as an inducement equity award outside Fusion’s 2020 Stock Option and Incentive Plan and was made as an inducement material to Dr. Dussault’s acceptance of employment with Fusion. Each option grant has an exercise price equal to the closing price of Fusion’s common shares on June 8, 2021. Each option has a ten-year term and vests over four years, with 25% of the original number of shares vesting on the one-year anniversary of the grant date and monthly thereafter, subject to Dr. Dussault’s continued service with Fusion through the applicable vesting dates.

About Fusion

Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion’s lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform which includes internal research and development capabilities, manufacturing and supply chain expertise, and the Company’s proprietary Fast-Clear™ linker technology.

For further information, contact: Amanda Cray, Senior Director of Investor Relations & Corporate Communications, 617-967-0207, cray@fusionpharma.com

TORONTO, ON, June 3, 2021: Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that the company’s drug candidate EB01 has met a key interim study parameter. The company has now passed the initial inflection point of its Phase2b study and will continue enrolling the final cohort of patients.

Edesa reported that interim study data from the first cohort met statistical thresholds previously approved by the U.S. Food and Drug Administration as part of an adaptive Phase 2b trial evaluating EB01 as a monotherapy for moderate to severe chronic Allergic Contact Dermatitis (ACD). Though blinded to treatment assignment, the study’s Data and Safety Monitoring Board (DSMB) reported an approximately 1.7-fold difference between the treatment arms for the primary efficacy endpoint, which is the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29.

Likewise, the DSMB reported an approximately 1.8-fold difference between the treatment arms in the proportion of patients achieving success on the ISGA (Investigator’s Static Global Assessment), a key secondary efficacy endpoint. Success on the ISGA is defined as a two-point reduction from baseline and a final ISGA score of ‘0’ or ‘1’ indicating clear or almost clear skin, respectively. A decrease in score relates to an improvement in signs and symptoms. For both the CDSI and ISGA endpoints, double-digit absolute differences were observed among the two treatment arms. No serious treatment-related adverse events were reported for either treatment group.

Based on these findings, the DSMB has recommended progression to the second cohort of patients. Interim study data is preliminary and full study results are subject to change; and since the analysis remains blinded, it is not possible to definitively conclude if EB01 may be outperforming placebo or vice versa. The initial cohort analyzed consisted of a population of 46 subjects, of whom 36 completed the study follow-up and were used in the interim analysis. As of June 2, 2021, 66 total patients (including the first cohort) have been randomized in the Phase 2b study.

“This milestone represents a significant step in our plans to develop an effective and safe treatment option for chronic ACD patients. Although blinded, these results are highly encouraging and we are excited to move into the final phase of the study,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “I would like to thank the patients, physicians and research staff for enabling us to reach this important milestone and we are encouraged by the ongoing interest in the novel mechanism of action employed by EB01.”

Blair Gordon, PhD, Vice President of Research and Development, said that based on the interim findings and the safety monitoring board’s recommendations, Edesa will continue with an additional cohort of at least 120 evaluable subjects, who will be provided with either Edesa’s EB01 topical treatment (at a 2.0%, 1.0% and 0.2% concentration) or a placebo cream. The company is also evaluating a potential open-label extension for study patients.

“We are excited to see meaningful early signals between the treatment arms for both the CDSI and ISGA interim endpoints. Now that we are beyond the futility cut-off hurdle, we are fine-tuning the final subject population to be in the best position to demonstrate unequivocal results for both these endpoints, which will be important for Phase 3 trial design,” said Dr. Gordon.

EB01 cream contains a non-steroidal anti-inflammatory compound known as an sPLA2 (secretory phospholipase-2) inhibitor. Since EB01 is designed to inhibit the inflammatory process at its inception rather than after inflammation has occurred, the company believes that the drug could potentially exert a powerful anti-inflammatory effect without the safety concerns of steroids. In two previous clinical studies EB01 has demonstrated statistically significant improvement of multiple symptoms in ACD patients.

Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States. The disease has been estimated to cost up to $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with academic literature pointing to a potentially larger undiagnosed population. More than one million patients are estimated to have chronic ACD. To the company’s knowledge there are currently no treatment options specifically labelled for ACD.

JSS Medical Research is acting as Edesa’s contract research organization for the Phase 2b study. Physicians interested in participating in the study should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT03680131).

About Edesa Biotech, Inc.
Edesa Biotech, Inc. (Nasdaq:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts.

Edesa Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s plans regarding its Phase 2b clinical study, the company’s belief that data from the full study population will demonstrate statistical significance, plans to adjust subject population to be in the best position to demonstrate unequivocal results for both for the CDSI and ISGA endpoints, and the company’s belief that EB01 could potentially exert a powerful anti-inflammatory effect without the safety concerns of steroids. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as COVID-19. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

Contact
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
investors@edesabiotech.com

SOURCE: Edesa Biotech

HAMILTON, ON and BOSTON, June 2, 2021: Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced it entered a 15-year lease agreement with Hamilton, Ontario-based McMaster University to build a 27,000 square foot current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. The facility, to be built by McMaster and equipped and validated by Fusion, will be designed to support manufacturing of the Company’s growing pipeline of targeted alpha therapies (TATs). Fusion expects the manufacturing facility will be operational by early 2024.

“Manufacturing and supply chain are critical components of radiopharmaceutical development and commercialization, and with Fusion’s expertise, we believe we are well-positioned to create a facility to scale production in support of our growing pipeline and development collaborations,” said Fusion Chief Executive Officer John Valliant, Ph.D. “We will continue to prioritize manufacturing and supply chain infrastructure in our long-term plans, and this facility is an important milestone in executing those plans.The location of the facility, adjacent to our internal research organization and a world-class University that specializes in medical isotope research and training, enables us to efficiently advance new TATs and hire top tier talent to support our leading portfolio of radiopharmaceuticals.”  

In conjunction with the execution of the lease agreement, Fusion has entered into a services agreement with its long-time partner, the Centre for Probe Development and Commercialization (CPDC), to provide services relating to certain aspects of the validation of this new manufacturing facility.

About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors.

Fusion’s lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966 targeting the fibroblast growth factor receptor 3 (FGFR3) and FPI-2059, a small molecule recently acquired from Ipsen, targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop up to three novel targeted alpha therapies (TATs) and explore up to five combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion also recently entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (Pembrolizumab) in patients with solid tumors expressing IGF-1R.

Forward-Looking Statements
Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would” or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause Fusion’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the development, build-out and operations of a manufacturing facility, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises and other matters that could affect the sufficiency of existing cash to fund operations. Fusion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Fusion’s quarterly report on Form 10-Q for the period ended March 31, 2021 which is available on the Securities and Exchange Commission’s website at www.sec.gov and Fusion’s website at www.fusionpharma.com.  

SOURCE Fusion Pharmaceuticals Inc.

BOSTON and MONTRÉAL, May 27, 2021: enGene Inc., a clinical-stage biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, today announced the dosing of the first patient in the LEGEND study, a first-in-human Phase 1/2 clinical trial of EG-70 in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

Based on enGene’s DDX platform, EG-70 is a non-viral gene therapy encoding two RIG-I agonists to stimulate the innate immune system, and IL-12 to stimulate the adaptive immune system. By stimulating both arms of the immune system, intravesically administered EG-70 yields remarkable tumor regression in preclinical models of bladder cancer, with induction of effective immunological memory and minimal signs of toxicity.

“Initiating our first clinical study of EG-70 is an important milestone for enGene, validating the potential of our platform to develop novel therapeutics towards clinically meaningful outcomes,” said Jason Hanson, Chief Executive Officer at enGene. “This is the first time a non-viral gene therapy directly activating both innate and adaptive immunity is being evaluated as an anti-tumor agent in humans, and we are excited about the outcome of this trial towards positively impacting the lives of patients battling difficult-to-treat cancers.”

“Patients with BCG-unresponsive high risk NMIBC have limited treatment options other than radical cystectomy which is associated with significant morbidity and quality of life alterations. Based on our understanding of high grade bladder cancer, the mechanism of BCG resistance/relapse, and the EG-70 mechanism of action, I strongly believe that this novel intravesical therapy has the potential, with few side effects, to make a meaningful difference for patients,” said Dr. Gary Steinberg, Professor and Director at the Perlmutter Cancer Center Goldstein Urology Bladder Cancer Program of NYU Langone Health, and lead Principal Investigator for the EG-70 Phase 1/2 study.

The LEGEND study, both first-in-human and first-in-class, is an open-label, monotherapy, multi-center, dose-escalation trial evaluating safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of EG-70 administered by intravesical instillation. To learn more about the first-in-human clinical trial of EG-70 in BCG-unresponsive NMIBC, please visit ClinicalTrials.gov. 

About enGene Inc.
enGene Inc. is a clinical-stage biotechnology company developing non-viral gene therapies based on localized delivery of nucleic acid payloads to mucosal tissues. The dually derived chitosan (DDX) platform has a high-degree of payload flexibility including DNA and various forms of RNA with broad tissue and disease applications. In preclinical models, enGene’s DDX technology has been demonstrated to effectively induce expression of therapeutic genes following delivery to the lung, gastrointestinal tract and urinary bladder. Engene has developed scalable GMP-compliant manufacturing of DDX products. http://www.engene.com 

Note regarding forward-looking statements
This press release contains certain “forward-looking statements” that reflect the Company’s beliefs and assumptions based on currently available data and information. These forward-looking statements fall within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on enGene’s current beliefs, expectations, and assumptions that by definition involve risks, uncertainties, that are difficult to predict and are subject to factors outside of management’s control and that could cause actual results to differ substantially from statements made including but not limited to: risks associated with the success of preclinical studies, clinical trials, research and development programs, as well as regulatory approval processes. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. enGene has no approved drugs available for sale marketing at this time and may never have an approved drug. You are cautioned not to rely on enGene’s forward looking statements, which are only made as of the date hereof. The Company is under no obligation to update these statements.

SOURCE enGene

Related Links

http://engene.com/

BioTheryX, Inc., a clinical-stage company focused on degrading proteins to create life-saving cancer medicines, today announced a $92 million Series E financing led by Farallon Capital Management, with participation from additional new investors Avidity Partners, Deep Track Capital, Janus Henderson Investors, Lumira Ventures, Point72, Rock Springs Capital, Surveyor Capital, Tekla Capital Management, Alexandria Venture Investors and existing investors.

The proceeds from the financing will be used to advance multiple molecular glues, PHM-based PROTACs and monovalent degraders, including BTX-1188, toward clinical development.  BioTheryX also plans to advance the clinical development of its lead multi-kinase inhibitor, BTX-A51, for the treatment of acute myeloid leukemia, myelodysplastic syndromes and solid tumors.

“We are pleased to have the support of an elite group of investors who share BioTheryX’s vision of realizing the promise of targeted protein degradation and delivering benefit to patients,” said Robert Williamson, President and CEO of BioTheryX.  “With this financing, we are well positioned to execute our plans to bring our first molecular glue program BTX-1188 into the clinic by the end of 2021, expand our platform of molecular glues, PROTACs and monovalent degraders and progress our lead program BTX-A51 through Phase 1.”

About BioTheryX, Inc.

BioTheryX is a clinical-stage biopharmaceutical company focused on restoring protein homeostasis, including protein degradation and modulation, and multi-kinase inhibition to develop treatments intended to extend and improve the quality-of-life of patients with cancer and other diseases. Our principal technology platform centers on targeted protein degradation, PHM® ‘molecular glues’, that enable the design of small molecules to regulate protein equilibrium. This technology is designed to utilize the body’s own protein disposal system to selectively degrade and remove disease-causing proteins. It has potential applicability for a broad range of diseases, including targets that have to date been considered ‘undruggable’, and BioTheryX is initially focused on treating oncology indications with high unmet need.  For more information, please visit www.biotheryx.com and engage with us on LinkedIn.

HAMILTON, ON and BOSTON, May 6, 2021 /PRNewswire/ — Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that it has entered into a clinical trial collaboration with a subsidiary of Merck (known as MSD outside the U.S. and Canada) to evaluate Fusion’s lead candidate, [²²⁵Ac]-FPI-1434 (FPI-1434), in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA® (pembrolizumab), in patients with solid tumors expressing insulin-like growth factor 1 receptor (IGF-1R).

“With our strong preclinical data demonstrating promising activity with FPI-1434 and immuno-oncology agents, we believe we have an opportunity to improve efficacy in tumor indications where KEYTRUDA is approved, and to potentially expand into new tumor indications,” said Chief Executive Officer John Valliant, Ph.D. “This collaboration with Merck builds off our research on the mechanism of action of alpha radiation and aligns with our goal to expand the utility of radiopharmaceutical therapies, including advancing into earlier lines of cancer therapy.”

The planned Phase 1/2 combination trial will evaluate safety, tolerability and pharmacokinetics of FPI-1434 in combination with pembrolizumab and is expected to initiate approximately six to nine months after achieving the recommended Phase 2 dose in the ongoing Phase 1 study of FPI-1434 monotherapy. Under the terms of the agreement, Fusion will sponsor the study and Merck will supply KEYTRUDA.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About FPI-1434
FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion’s Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.

About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion’s lead program, FPI-1434, is currently in a Phase 1 clinical trial.

Forward-Looking Statements
Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would” or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause Fusion’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Fusions’ programs’ early stage of development, the process of designing and conducting clinical trials, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises and other matters that could affect the timing and outcome of our clinical trials and the sufficiency of existing cash to fund operations. Fusion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Fusion’s annual report on Form 10-K for the year ended December 31, 2020 which is available on the Security and Exchange Commission’s website at www.sec.gov and Fusion’s website at www.fusionpharma.com.

SOURCE: Fusion Pharmaceuticals Inc.

For more information, please contact: Amanda Cray, Senior Director of Investor Relations & Corporate Communications, 617-420-5698, cray@fusionpharma.com

OTTAWA, ON, May 4, 2021 /CNW/ – Today the Rideau Hall Foundation announced the recipients of the sixth annual Governor General’s Innovation Awards. These awards recognize and celebrate exceptional Canadian individuals, teams and organizations for their excellence in innovation and their contributions to helping shape our future and positively impact our quality of life.

The recipients of the 2021 Governor General’s Innovation Awards are:

Swift Medical: AI Powered Wound Care

(Dr. Sheila Wang) 

Dr. Sheila Wang receives the Governor General’s Innovation Award for her leadership in the creation of an artificial intelligence-driven technology for monitoring wound care patients remotely. The technology is being deployed by Swift Medical across North America to help thousands of wound care patients access immediate, virtual wound care while remaining in their own homes.

Nominated by Mitacs 

Arctic Corridors and Northern Voices

(Dr. Jackie Dawson, Dr. Natalie Carter, Ms. Natasha Simonee, Ms. Shirley Tagalik) 

The team led by Dr. Jackie Dawson and including Dr. Natalie Carter, Ms. Natasha Simonee, and Ms. Shirley Tagalik, receives a Governor General’s Innovation Award for their innovative integration of traditional Inuit knowledge and western science. Their work is leading to the creation of new routes for Arctic shipping that better protect culturally significant marine areas. The project supports national and international ocean policy and has made the region a global leader in self-determined science.

Nominated by the Social Sciences and Humanities Research Council   

Distributed Acoustic Sensor

 (Dr. Xiaoyi Bao) 

Dr. Xiaoyi Bao transformed the field of structural monitoring with her invention of Distributed Acoustic Sensor (DAS), an ultra-sensitive and precise optical fiber-based technology installed in civil structures, and capable of detecting dynamic stress and high and low frequency vibrations indicative of crack formation. Her technology, which has more applications, smaller size, better predictive capacity and cost point, showcases Canada as an innovative force for change on the world stage. Not only is Dr. Bao’s technology saving governments millions in maintenance, but most importantly, it is helping to protect the environment from oil spills and saving lives by ensuring the integrity of bridges, pipelines, railways and airplanes worldwide.

Nominated by Natural Sciences and Engineering Research Council of Canada   

3D Printed Patient Devices for Cancer Treatment and Radiotherapy

(Dr. James Robar) 

Dr. Robar is being recognized for integrating 3D printing into the treatment of skin, breast, head/neck and gynecological cancers. The software, now being deployed by Adaptiiv Medical Technologies Incorporated at leading cancer centres worldwide, enables the design of patient-specific radiotherapy accessories that improve treatment accuracy and patient experience.  

Nominated by the Discovery Centre  

International Tobacco Control Policy Evaluation (ITC) Project

(Dr. Geoffrey T. Fong, Dr. David Hammond, Dr. Mary E. Thompson)

With the persistent leadership of Dr. Geoffrey T. Fong, the ITC Project, centered at the University of Waterloo, is globally renowned for its innovative research supporting and defending effective tobacco control policies such as graphic health warnings, smoke free laws, advertising bans, and tobacco taxes. This pioneering research, across 29 countries covering over half of the world’s population, has led Canada and many other countries to strengthen their tobacco control efforts, improving the health of millions of people worldwide. 

Nominated by Canadian Institutes of Health Research   

Mi’kmaw Kina’matnewey-Canadian Leaders in Indigenous Education

(Chief Leroy Denny, Ms. Blaire Gould) 

In contrast to dominant Eurocentric school systems and in the devastating aftermath of Indian Residential Schools, Mi’kmaw Kina’matnewey, a collective of 12 Mi’kmaq communities in Nova Scotia, has emerged as an education authority that is community-based and Mi’kmaq led. Mi’kmaw Kina’matnewey has achieved this through collaborative governance, effective planning, strategic influence and transformative Mi’kmaq teacher education. The result has been an enabling environment for Mi’kmaq culture, language, and identity to thrive, all while achieving educational outcomes which far exceed national averages for on-reserve and off-reserve education.

Nominated by the Forge Institute  

2021 GGIA Selection and Assessment Committees

The Governor General’s Innovation Award Selection and Assessment Committees are composed of distinguished individuals chosen for their expertise in and breadth of understanding of the Canadian innovation ecosystem.

2021 GGIA Selection Committee:

• Charles Deguire, (Committee Chair), Co-founder and CEO, Kinova Inc. and GGIA Laureate 2016
• Kelly Gillis, Deputy Minister, Infrastructure Canada
• John Knubley, Senior Business Advisor, InnovAction Advisory Services Inc.
• Breanne Everett, President and CEO of Orpyx Inc. and GGIA Laureate 2016
• Carol Anne Hilton, CEO and Founder of the Indigenomics Institute and the Global Center of Indigenomics
• John Stackhouse, Senior Vice-President, Office of the CEO, RBC

2021 GGIA Assessment Committee:

• Fred Morley (Committee Chair), Founder and Chief Economist, Rising Tide Economics
• David Brown, co-founder and COO of Chinova Bioworks, Founder of Mycodev Group and GGIA Laureate 2017
• Robert Luke, Chief Executive Officer, eCampusOntario
• Audra Renyi, Executive Director of World Wide Hearing Foundation, Founder of earAccess Inc. and GGIA Laureate 2017
• Gena Rotstein, Principal, Karma and Cents
• Patricia Francis, Independent Consultant / Archive Coordinator, For the Development of an Archival Complex on The Akwesasne Territory
• Sandra Wear, VP Marketing & Communications at Innovate BC

A virtual event celebrating the 2021 GGIA Laureates will take place on May 20, 2021 during Canadian Innovation Week (May 17^th to 21^st).

To register for this virtual event follow this link.

About the Governor General’s Innovation Awards

Launched in 2016, the Governor General’s Innovation Awards inspire Canadians to embrace innovation and to emulate innovative, entrepreneurial risk-takers who have developed new or better ways of creating value and who are having a meaningful impact on our quality of life.

The Awards are given to individuals, teams and/or organizations whose innovations are:

• truly exceptional;
• transformative; and,
• positive in their impact on quality of life in Canada.

Each year, up to six award winners are identified through a two-stage, merit-based selection process. For more information on the awards visit innovation.gg.ca.

About the Rideau Hall Foundation

The Rideau Hall Foundation is an independent and non-political charitable organization established to mobilize ideas, people, and resources across the country to tap into our national spirit and help realize our shared aspirations. The RHF works closely with many partners, including the Office of the Secretary to the Governor General, to connect, honour, and inspire Canadians across four key programmatic areas, including: (1) learning initiatives that strive for excellence and promote equality of opportunity; (2) strengthening Canada’s culture of innovation, (3) widening the circle of giving and volunteering; and (4) building and celebrating excellence in Canadian leadership, and increasing public awareness about and commitment to Canada’s multi-faceted democracy. The RHF manages all aspects of the Governor General’s Innovation Awards.

SOURCE Rideau Hall Foundation

For further information: For media inquiries, contact: Jill Clark, Rideau Hall Foundation, 613-809-1480, Jill.clark@rhf-frh.ca

Related Links

http://www.rhf-frh.ca/

– PRESERVE 2 Will Evaluate Survival Benefit of COSELA in 250 Patients with Locally Advanced Unresectable or Metastatic TNBC

RESEARCH TRIANGLE PARK, N.C., April 28, 2021 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced the initiation of PRESERVE 2, a pivotal Phase 3, randomized, double-blind, placebo-controlled study of COSELA™ (trilaciclib) in patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for locally advanced unresectable or metastatic triple-negative breast cancer (mTNBC). COSELA shows preclinical and clinical evidence of immune system enhancement which G1 is exploring in clinical trials in a variety of different tumor types to evaluate the potential of increased anti-tumor efficacy. Results of this study are expected in the second half of 2023.

“As a physician who treats people living with breast cancer, I can attest to the great need for new therapies to extend life while not adding to the side effect burden of chemotherapy,” said Joyce O’Shaughnessy, MD, Chair of Breast Cancer Research at Baylor University Medical Center, Texas Oncology, US Oncology in Dallas, TX. “Gemcitabine/carboplatin has historically been one of the standard first-line regimens for patients undergoing chemotherapy for mTNBC. In a Phase 2 study, when trilaciclib was administered prior to this regimen, it enhanced antitumor efficacy compared to gemcitabine/carboplatin alone, and improved overall survival with statistical significance. This is an important finding for patients with mTNBC, and for physicians who treat them. I’m excited to begin enrolling patients in this registrational trial and look forward to the possibility of a new, well-tolerated, and life-extending agent for my patients.”

Patient enrollment in PRESERVE 2 is now underway. The study will enroll two cohorts of patients. Cohort 1 (n=170) will evaluate patients receiving first-line therapy, regardless of PD-L1 status, who are PD-1/PD-L1 inhibitor-naïve. Cohort 2 (n=80) will evaluate PD-L1 positive patients receiving second-line therapy following prior PD-1/PD-L1 inhibitor therapy in the locally advanced unresectable/metastatic setting. These two cohorts are adequately powered and considered independent of each other. Therefore, the efficacy and safety data collected for each cohort will be analyzed separately.

Within each cohort, patients meeting entry criteria will be randomly assigned (1:1) to receive either COSELA prior to gemcitabine and carboplatin (GC) therapy (the same dosing regimen used in Group 2 of our Phase 2 study) or placebo prior to GC therapy. Study drugs will be administered intravenously (IV) on Days 1 and 8 in 21-day cycles. Study drug administration will continue until progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or clinical progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the study, whichever occurs first.

The primary endpoint in Cohort 1 is to evaluate the effect of COSELA on overall survival (OS) compared with placebo in patients receiving first-line GC. The primary endpoint of Cohort 2 is to evaluate the effect of COSELA on OS compared with placebo in patients receiving GC as second line therapy after treatment with a PD-1/PD-L1 inhibitor. Key secondary endpoints in both trials include assessment of the effect of COSELA on patients’ quality of life compared with placebo.

“Given that triple-negative breast cancer tends to be more aggressive and have a worse prognosis than other types of breast cancer, we recognize and share the urgency to conduct this trial and are enthusiastic about the potential for COSELA to significantly improve TNBC patient outcomes,” said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. “This registrational trial follows the final data from our Phase 2 trial in mTNBC which were presented in December at the 2020 San Antonio Breast Cancer Symposium (SABCS) meeting, showing a strong survival benefit in patients receiving COSELA compared to placebo when given prior to chemotherapy, and regardless of tumor PD-L1 status. Based on those data, we believe that the unique mechanism of action of COSELA has the potential to increase antitumor efficacy and be highly beneficial to people fighting TNBC.”

Results from Randomized Phase 2 Trial of COSELA in mTNBC 

New data presented at the 2020 SABCS meeting showed that COSELA significantly improved overall survival (OS) in patients with mTNBC treated with COSELA prior to administration of a chemotherapy regimen of gemcitabine/carboplatin (GC) compared with GC alone, and that COSELA enhanced immune system function. Patients were randomized to receive GC only (Group 1) or GC plus one of two dosing schedules of COSELA: COSELA administered on the day of chemotherapy (Group 2) or COSELA administered the day prior to and the day of chemotherapy (Group 3). Compared to GC alone (Group 1), statistically significant improvements in OS were achieved in both COSELA arms (Group 2: HR=0.31, p=0.0016; Group 3: HR=0.40, p=0.0004). As of the data cutoff of July 17, 2020, the median OS was 12.6 months in patients receiving GC alone, not yet reached for Group 2, and 17.8 months in Group 3. The median OS for Groups 2 and 3 combined was 19.8 months (HR=0.37, p<0.0001). Patients with both PD-L1-positive and PD-L1-negative tumors treated with COSELA and GC demonstrated improvement in OS compared to patients receiving GC alone, with the PD-L1-positive subset achieving statistically significant improvement. Data from T-cell clonality analysis suggest that administering COSELA prior to chemotherapy enhanced immune system function. (Poster here)

About Triple Negative Breast Cancer (TNBC)
According to the American Cancer Society, nearly 300,000 new cases of invasive breast cancer are diagnosed annually in the U.S. Triple-negative breast cancer makes up approximately 15-20% of such diagnosed breast cancers. TNBC is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. Because mTNBC cells lack key growth-signaling receptors, patients do not respond well to medications that block estrogen, progesterone, or HER2 receptors. Instead, treating mTNBC typically involves chemotherapy, radiation, and surgery. TNBC is considered to be more aggressive and have a poorer prognosis than other types of breast cancer. In general, survival rates tend to be lower with mTNBC compared to other forms of breast cancer, and mTNBC is also more likely than some other types of breast cancer to return after it has been treated, especially in the first few years after treatment. It also tends to be higher grade than other types of breast cancer.

About G1 Therapeutics
G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA™ (trilaciclib). G1 has a deep clinical pipeline and is executing a tumor-agnostic development plan evaluating COSELA in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

G1 Therapeutics™ and the G1 Therapeutics logo and COSELA™ and the COSELA logo are trademarks of G1 Therapeutics, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, COSELA’s (trilaciclib) possibility to improve patient outcomes, our pivotal Phase 3 trial of COSELA in mTNBC may not be able to replicate the strong survival benefit we observed in our Phase 2 trial of COSELA in mTNBC, delays in the enrollment of patients in our Phase 3 trial of COSELA in mTNBC, may delay or prevent our plans, and COSELA may fail to achieve the degree of market acceptance for commercial success, are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the company’s dependence on the commercial success of COSELA; the development and commercialization of new drug products is highly competitive; the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

For more information, please contact:

Will Roberts
G1 Therapeutics, Inc.
Vice President
Investor Relations and Corporate Communications
(919) 907-1944
wroberts@g1therapeutics.com

– Pivotal Program Evaluated the Effects of Administering COSELA Prior to Chemotherapy on Clinically Relevant Endpoints Across Multiple Hematopoietic Lineages, Including Hematologic Adverse Events, Laboratory Values, and Use of Supportive Care Interventions –

– Compared with Placebo, Administering COSELA Prior to Chemotherapy Resulted in Significant Decreases in Most Measures of Multilineage Chemotherapy-Induced Myelosuppression (CIM), with a Reduction in the Incidence of Chemotherapy-Related Hematologic Adverse Events

RESEARCH TRIANGLE PARK, N.C., April 26, 2021 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the peer-reviewed journal of Clinical Lung Cancer has published the final pooled results from three clinical trials of COSELA™ (trilaciclib) in extensive-stage small cell lung cancer (ES-SCLC). Compared with placebo, administering COSELA prior to chemotherapy resulted in significant decreases in most measures of multilineage chemotherapy-induced myelosuppression (CIM), with a reduction in the incidence of chemotherapy-related hematologic adverse events. The myeloprotective benefits of COSELA translated into a reduced need for supportive care interventions and hospitalizations due to CIM or sepsis, and improvements in health-related quality of life (HRQoL) domains, including fatigue, physical well-being, and functional well-being, with no impact on the antitumor efficacy of the individual chemotherapy regimens in ES-SCLC.

COSELA was approved by the U.S. Food and Drug Administration on February 12, 2021 to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC.

The Clinical Lung Cancer publication, entitled Effects of Trilaciclib on Chemotherapy-Induced Myelosuppression and Patient-Reported Outcomes in Patients with Extensive-Stage Small Cell Lung Cancer: Pooled Results from Three Phase 2 Randomized, Double-Blind, Placebo-Controlled Studies (Weiss, J. et al.) can be found here.

“Cancer patients have two major sources of physical suffering – the cancer itself and the side effects of chemotherapy,” said Jared Weiss, MD, Associate Professor of Medicine, Division of Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina Chapel Hill, NC. “Small cell tends to present with bulky and rapidly growing central chest disease, which can compress airways and major vessels leading to shortness of breath, cough, and pain. While chemotherapy is great at shrinking the cancer and relieving these symptoms, it comes at the cost of side effects. The most common side effects from chemotherapy are suppression of blood counts and the consequences of that – neutropenia, anemia and fatigue. Trilaciclib helps decrease these side effects which can help optimize quality of life. With trilaciclib added to standard therapy, my patients experience less hematologic toxicity, a reduced need for supportive care interventions and hospitalizations due to CIM or sepsis, and ultimately improvements in health-related quality of life domains, including fatigue, and physical and functional well-being.”  

Data from three randomized, double-blind, placebo-controlled studies were pooled to evaluate the effects of COSELA administered prior to standard-of-care chemotherapy in patients with ES-SCLC. The primary endpoints were duration of severe neutropenia (DSN) in cycle 1, and occurrence of severe neutropenia (SN). Additional prespecified endpoints further assessed the effect of COSELA on myeloprotection, HRQoL, antitumor efficacy, and safety.

Of 242 randomized patients, 123 received COSELA and 119 received placebo. Compared with placebo, administration of COSELA prior to chemotherapy resulted in significant decreases in most measures of multilineage CIM. For example, statistically significant improvements in the primary endpoints of duration of severe neutropenia in cycle 1 and occurrence of severe neutropenia were observed in the COSELA group versus the placebo group. Mean (standard deviation) DSN in cycle 1 was 0 days (1.8) with COSELA versus 4 days (5.1) with placebo (P < 0.0001), and throughout the treatment period, 14 (11.4%) patients in the COSELA group had SN versus 63 (52.9%) patients in the placebo group (P < 0.0001). Most secondary myelosuppression endpoints, including the percentage of patients with G-CSF administration, grade 3/4 anemia, RBC transfusions on/after week 5 of study treatment, ESA administrations, and grade 3/4 thrombocytopenia also significantly favored COSELA over placebo.

The reduction in hematologic toxicity translated into the reduced need for supportive care interventions and hospitalizations due to CIM or sepsis, and improvements in HRQoL domains related to the protected cell lineages, including physical and functional wellbeing, symptoms and impact of fatigue, and the symptoms and effects on physical and functional wellbeing due to anemia as reported in the patient reported outcome data.

The authors concluded that administering COSELA prior to chemotherapy resulted in clinically meaningful reductions in CIM and its consequences, and improved patient HRQoL, with no impact on the antitumor efficacy of three individual chemotherapy regimens used in the first- or second-/third-line treatment of ES-SCLC.

About COSELA™ (trilaciclib)

COSELA^TM (trilaciclib) is the first and only myeloprotection therapy to help decrease the incidence of chemotherapy-induced myelosuppression. Administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy, COSELA helps proactively deliver multilineage myeloprotection to patients with extensive-stage small cell lung cancer (ES-SCLC) being treated with chemotherapy. COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC.

About Small Cell Lung Cancer

In the United States, approximately 30,000 small cell lung cancer patients are treated annually. SCLC, one of the two main types of lung cancer, accounts for about 10% to 15% of all lung cancers. SCLC is an aggressive disease and tends to grow and spread faster than NSCLC. It is usually asymptomatic; once symptoms do appear, it often indicates that the cancer has spread to other parts of the body. About 70% of people with SCLC will have cancer that has metastasized at the time they are diagnosed. The severity of symptoms usually increases with increased cancer growth and spread. From the time of diagnosis, the general 5-year survival rate for people with SCLC is 6%. The five-year survival rates for limited-stage (the cancer is confined to one side of the chest) SCLC is 12% to 15%, and for extensive stage (cancer has spread to the other lung and beyond), survival rates are less than 2%. Chemotherapy is the most common treatment for ES-SCLC.

COSELA™ (trilaciclib) for Injection

INDICATION
COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

• COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

WARNINGS AND PRECAUTIONS

Injection-Site Reactions, Including Phlebitis and Thrombophlebitis

• COSELA administration can cause injection-site reactions, including phlebitis and thrombophlebitis, which occurred in 56 (21%) of 272 patients receiving COSELA in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions. Monitor patients for signs and symptoms of injection-site reactions, including infusion-site pain and erythema during infusion. For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue COSELA. Injection-site reactions led to discontinuation of treatment in 3 (1%) of the 272 patients.

Acute Drug Hypersensitivity Reactions

• COSELA administration can cause acute drug hypersensitivity reactions, which occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). Monitor patients for signs and symptoms of acute drug hypersensitivity reactions. For moderate (Grade 2) acute drug hypersensitivity reactions, stop infusion and hold COSELA until the adverse reaction recovers to Grade ≤1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue COSELA.

Interstitial Lung Disease/Pneumonitis

• Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, including COSELA, with which it occurred in 1 (0.4%) of 272 patients receiving COSELA in clinical trials. Monitor patients for pulmonary symptoms of ILD/pneumonitis. For recurrent moderate (Grade 2) ILD/pneumonitis, and severe (Grade 3) or life-threatening (Grade 4) ILD/pneumonitis, permanently discontinue COSELA.

Embryo-Fetal Toxicity

• Based on its mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with COSELA and for at least 3 weeks after the final dose.

ADVERSE REACTIONS

• Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis.
• Fatal adverse reactions were observed in 5% of patients receiving COSELA. Fatal adverse reactions for patients receiving COSELA included pneumonia (2%), respiratory failure (2%), acute respiratory failure (<1%), hemoptysis (<1%), and cerebrovascular accident (<1%).
• Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA. Adverse reactions leading to permanent discontinuation of any study treatment for patients receiving COSELA included pneumonia (2%), asthenia (2%), injection-site reaction, thrombocytopenia, cerebrovascular accident, ischemic stroke, infusion-related reaction, respiratory failure, and myositis (<1% each).
• Infusion interruptions due to an adverse reaction occurred in 4.1% of patients who received COSELA.
• The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

DRUG INTERACTIONS

• COSELA is an inhibitor of OCT2, MATE1, and MATE-2K. Co-administration of COSELA may increase the concentration or net accumulation of OCT2, MATE1, and MATE-2K substrates in the kidney (e.g., dofetilide, dalfampridine, and cisplatin).

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information here

For more information about COSELA, please call 1-800-790-G1TX (1-800-790-4189)

About G1 Therapeutics
G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA™ (trilaciclib). G1 has a deep clinical pipeline evaluating targeted cancer therapies in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

G1 Therapeutics™ and the G1 Therapeutics logo and COSELA™ and the COSELA logo are trademarks of G1 Therapeutics, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those relating to expectations for the commercial launch of COSELA (trilaciclib), the therapeutic potential of COSELA (trilaciclib), and COSELA’s (trilaciclib) possibility to improve patient outcomes across multiple indications, and COSELA (trilaciclib) may fail to achieve the degree of market acceptance for commercial success, are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the company’s ability to complete a successful commercial launch for COSELA (trilaciclib); the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates other than COSELA (trilaciclib); the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a commercial-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

For more information, please contact:
Will Roberts
Vice President, Investor Relations & Corporate Communications
919-907-1944
wroberts@g1therapeutics.com

–SAVE 1 to evaluate ATI-2173 in combination with tenofovir (TDF) vs. TDF plus placebo

-SAVE 1 to include cohort of Hepatitis Delta Virus (HDV) co-infected subjects to assess ATI-2173 activity against HDV

MENDHAM, N.J., April 21, 2021 (GLOBE NEWSWIRE) — Antios Therapeutics, Inc. (“Antios”) today announced that it has dosed the first patients in its Sustained Anti-Viral Efficacy (SAVE) clinical trial, a Phase 2a study of ATI-2173, an Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development as a backbone of a potentially curative regimen for chronic HBV.

The double-blind randomized controlled trial plans to enroll 30 patients and will assess the safety and efficacy of 25mg and 50mg doses of ATI-2173 in combination with tenofovir (TDF) compared with TDF plus ATI-placebo (control) in chronic HBV-infected subjects. A third cohort will evaluate 50mg of ATI-2173 and TDF against the control arm in HBV/HDV co-infected subjects. Efficacy will be assessed by both on-treatment maximum HBV DNA level responses and by off-treatment sustained virologic responses (SVR)s for the treatment arms in HBV-mono-infected subjects and by HDV RNA treatment responses in the HBV/HDV-coinfected subjects.

Following a screening period of up to eight weeks, subjects will be randomized to receive either once-daily, oral ATI-2173 plus TDF arm or control for 12 weeks, after which they will be evaluated off therapy during a 24-week follow-up period. Subjects’ HBV DNA will be measured regularly during both the treatment and follow-up periods. Subjects whose HBV DNA remains undetectable at six months post-treatment will be followed for up to an additional 18 months. Additional details of the clinical trial are available on clinicaltrials.gov (NCT04847440).

“We saw evidence of durable on- and off-treatment viral suppression in the Phase 1b study where ATI-2173 monotherapy was given for only 28 days,” said Gregory Mayes, chief executive officer of Antios. “We believe that the unique ability of ATI-2173 to inhibit all stages of HBV DNA synthesis could generate additional SVRs following three months of finite treatment in combination with the standard of care, TDF, potentially turning HBV from a chronic disease to a curable one for some patients.”

Douglas Mayers, chief medical officer of Antios added, “In addition to determining the ability of ATI-2173 to generate increased levels of SVR, this will be an extremely important study, as it may also provide proof-of-concept for the drug to be used as a treatment for HDV. Preclinical work in woodchuck models of HBV/HDV coinfection has demonstrated the ability of ATI-2173’s active metabolite to significantly reduce HDV RNA levels. This would be a tremendously promising finding if replicated in humans, as effective treatment of HDV remains a high unmet need. We anticipate completing dosing for SAVE 1 before the end of 2021 and presenting the results at a future scientific conference.”

About ATI-2173
ATI-2173 is a novel, orally administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) molecule designed to deliver the 5’-monophosphate of clevudine to the liver where it is metabolized to the active 5’-triphosphate. This L-nucleoside’s active 5’-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor that distorts the active site of HBV polymerase resulting in potent HBV antiviral activity and extended off-treatment suppression of HBV DNA. ATI-2173 targets the liver, delivering high levels of the unique 5’- triphosphate while limiting systemic exposure to the parent L-nucleoside. ATI-2173 has the potential to become an integral part of a curative combination regimen for chronic hepatitis B.

About Antios Therapeutics Inc.
Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Antios is currently developing ATI-2173, aiming to provide chronic hepatitis B infected patients with a curative combination regimen.

For more information, please contact:

Investors:
Lee Roth
Burns McClellan
lroth@burnsmc.com
+1 (212) 300-8331

Media:
Ryo Imai / Robert Flamm, Ph.D.
Burns McClellan
rimai@burnsmc.com / rflamm@burnsmc.com
+1 (212) 300-8315 / +1 (212) 300-8364

– Data provides springboard to advance three additional clinical programs evaluating Tegavivint in acute myeloid leukemia (AML), non-small cell lung cancer (NSCLC) and pediatric cancers.

HOUSTON, April 13, 2021 /PRNewswire/ — Iterion Therapeutics, Inc., a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics, announced today that it has confirmed the safety of Tegavivint, a novel, potent and selective nuclear beta-catenin inhibitor, after completing enrollment and dosing the final patient in a multicenter Phase 1/2a dose expansion clinical study of Tegavivint in patients with desmoid tumors. 

Nuclear beta-catenin is a highly-studied oncology target associated with numerous cancer types. Tegavivint is unique among nuclear beta-catenin inhibitors in that it binds to TBL1 (Transducin Beta-like Protein One), a novel downstream target in the Wnt-signaling pathway.  As such, Tegavivint enables silencing of Wnt-pathway gene expression without affecting other Wnt/beta-catenin functions in the cell membrane, thus avoiding toxicity issues common to other drugs in this pathway.

The Phase 1/2a clinical trial of Tegavivint in patients with progressive desmoid tumors was designed as an open-label, non-randomized dose-finding study. The primary objectives of the study were to evaluate the safety and tolerability of Tegavivint. Secondary objectives were to determine the durability of response (DOR) to Tegavivint after the achievement of best response. The total study enrolled 24 patients. During the dose expansion portion of the trial 16 of these patients were treated with a recommended Phase 2 dose (RP2D) that was established based on pharmacokinetic exposure levels and clinical responses in a recently completed Phase 1 study.

Data from patients treated in the dose expansion portion of the trial reaffirmed Tegavivint’s safety at the RP2D level. No dose-limiting toxicities or significant adverse events were observed. This data will enable Iterion to accelerate clinical activity in additional cancer indications where nuclear beta-catenin signaling has been identified as a potential therapeutic target, including AML, NSCLC, and certain pediatric cancers.  Iterion expects to initiate clinical programs investigating Tegavivint for these indications in 2021.

“We have seen very good tolerability with no dose-limiting toxicities and no significant adverse events in escalating clinical doses,” said Casey Cunningham, Chief Medical Officer of Iterion. “We are seeing a very strong safety signal in patients who have been on Tegavivint for over a year and are also observing tumor activity in patients. We continue to follow the patients that are still receiving treatment and look forward to sharing efficacy results at an upcoming medical conference.”  

Rahul Aras, CEO of Iterion, stated: “The completion of enrollment in the dose expansion phase of our desmoid tumor clinical trial and demonstration of safety and clinical activity at the RP2D represent important milestones in our clinical development of Tegavivint. We look forward to advancing the clinical development of Tegavivint in desmoid tumors as this disease target is greatly underserved.  The results of this study also provide a ‘green light’ to initiate clinical development of Tegavivint in additional, high-value cancer settings, including AML, NSCLC, and certain pediatric cancers, that are characterized by nuclear beta-catenin overexpression.”

About Desmoid Tumors

Desmoid tumors are rare, non- metastasizing sarcomas that overexpress nuclear beta-catenin, a historically “undruggable” oncology target implicated in cell proliferation, differentiation and immune evasion.  An estimated 1,500 patients in the US are newly diagnosed with desmoid tumors each year. Desmoids are most commonly diagnosed in young adults between 30-40 years of age and are associated with significant morbidities, including severe pain, disfigurement, internal bleeding and organ damage, range of motion loss and, in rare cases, death. Iterion has received Orphan Drug Designation for Tegavivint to treat desmoid tumors, a disease for which there are no FDA approved therapies.

About Iterion Therapeutics

Iterion Therapeutics is a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics. The company’s lead product, Tegavivint, is a potent and selective inhibitor of nuclear beta-catenin, a historically “undruggable” oncology target implicated in cell proliferation, differentiation, immune evasion and stem cell renewal. Research demonstrating potent anti-tumor activity in a broad range of pre-clinical models indicate that Tegavivint has the potential for clinical utility in multiple cancer types. Tegavivint is currently the subject of a Phase 2a clinical trial in patients with progressive desmoid tumors. Iterion is also pursuing clinical programs in additional cancers where nuclear beta-catenin signaling has been shown to play a role, such as  AML, NSCLC, and pediatric cancers, including sarcomas, lymphoma and other solid tumors. This research/clinical trial was supported with a $15.9 million grant from the Cancer Prevention & Research Institute of Texas. For more information on Iterion, please visit https://iteriontherapeutics.com.

For more information, contact:

Tiberend Strategic Advisors, Inc.,Ingrid Mezo (Media),
646-604-5150
imezo@tiberend.com

Antios Therapeutics, Inc. (“Antios”) today announced the successful completion of a $96 million Series B financing. The proceeds from this financing will support the ongoing Phase 2 clinical program which is evaluating the potential for the Company’s lead clinical candidate, ATI-2173, to be a backbone of a once-daily curative regimen for chronic hepatitis B. ATI-2173 is a novel, orally administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) that can shut down HBV polymerase activity and viral replication.

The financing was led by Soleus Capital with participation from new major investors RA Capital Management, Adage Capital Management LP, Pontifax and Aisling Capital as well as other healthcare focused funds, Altium Capital, Amzak Health, Granite Point Capital Management, LP, and LifeSci Venture Partners and participation from all of the original Series A investors including Lumira Ventures, CAM Capital, Delos Capital, Domain Associates and Sixty Degree Capital. David Canner, Partner at Soleus Capital and Iyona Rajkomar, MBBS, CFA, Partner at Pontifax, are joining the Board of Directors.

“ATI-2173 has already demonstrated potent on-treatment and durable off-treatment effects in our Phase 1b study in patients with chronic hepatitis B,” said Greg Mayes, Chief Executive Officer of Antios. “Those results will be presented at an upcoming major medical conference. With this financing we are now well positioned to continue to highlight how ATI-2173 may become the backbone of a curative regimen for HBV which remains a significant unmet global public health need. We look forward to working with new and existing investors to advance ATI-2173 forward in development.”

Guy Levy, Chief Investment Officer of Soleus Capital said, “Despite significant progress in recent years, HBV remains an area of high unmet medical need. Given the mechanistic rationale and impressive early data, we believe ATI-2173 could play an essential role in developing curative regimens for the millions of people suffering from chronic HBV infection. We are excited to partner with the experienced team at Antios to help bring this therapy to patients.”

About ATI-2173
ATI-2173 is a novel, orally administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) molecule designed to deliver the 5’-monophosphate of clevudine to the liver. This L-nucleoside’s active 5’-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor that distorts the active site of HBV polymerase resulting in potent HBV antiviral activity and extended off-treatment suppression of HBV DNA. ATI-2173 targets the liver, delivering high levels of the unique 5’- triphosphate while limiting systemic exposure to the parent L-nucleoside. ATI-2173 has the potential to become an integral part of a curative combination regimen for chronic hepatitis B.

About Antios Therapeutics Inc.
Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Antios is currently developing ATI-2173, aiming to provide chronic hepatitis B infected patients with a curative combination regimen.

For more details, please contact:

Investors:
Lee Roth
Burns McClellan
lroth@burnsmc.com
+1 (212) 300-8331

Media:
Ryo Imai / Robert Flamm, Ph.D.
Burns McClellan
rimai@burnsmc.com / rflamm@burnsmc.com
+1 (212) 300-8315 / +1 (212) 300-8364

XyloCor Therapeutics Completes Oversubscribed $41.9 Million Series A Financing To Advance Novel Gene Therapy Pipeline For Coronary Artery Disease

– Company closes additional $22.6 million in new financing –

– Proceeds will fund initiation of new clinical trial for lead gene therapy candidate XC001 as adjunctive therapy for patients undergoing coronary artery bypass graft surgery –

Malvern, PA, March 22, 2021 — XyloCor Therapeutics, a private clinical‑stage biopharmaceutical company focused on the development of gene therapy for the significant unmet patient needs in advanced coronary artery disease, today announced the closing of an additional $22.6 million financing. Fountain Healthcare Partners led the oversubscribed financing joined by new investors Longwood Fund and Lumira Ventures. All existing institutional investors including Sofinnova Investments and LSP (Life Sciences Partners) participated in the financing. The additional financing builds upon XyloCor’s 2018 Series A financing round, bringing total investment in the company to $41.9 million to date. XyloCor’s lead product candidate, XC001, is an investigational gene therapy currently being studied in a Phase 1/2 clinical trial (EXACT) for patients with refractory angina, a chronic condition for which there are no treatment options.

The financing will enable XyloCor to expand its clinical development program for XC001, including the initiation of a new trial of XC001 as a potential adjunctive therapy to augment the effectiveness of coronary artery bypass graft surgery (CABG). XyloCor is at the forefront of scientific research and clinical study in the application of gene therapy to address vast unmet treatment needs in large patient populations with cardiovascular disease. In both its initial potential indication in refractory angina, and as an adjunctive therapy for patients undergoing CABG, XC001 represents a novel therapeutic approach.

“We greatly appreciate the recognition by Fountain Healthcare Partners, Longwood Fund, and Lumira Ventures of the value we have created since our initial funding and in XC001’s enormous potential for improving the lives of patients with advanced coronary disease,” said Al Gianchetti, president and chief executive officer of XyloCor Therapeutics. “With the support of our investors, we can build on the progress we have made since our initial funding to pursue, with a sense of urgency, new clinical indications where XC001 has promise for addressing unmet medical needs.”

“XyloCor has created significant value with XC001 with the progress the team has achieved on clinical and CMC milestones. Based on our experience, excellence on both fronts is critical to success in the gene therapy field,” said Aidan King, managing partner and co‑founder, Fountain Healthcare Partners, who also joined XyloCor’s board of directors. “We are gratified that this additional capital accelerates XC001’s development and expands its potential impact to the significant unmet need among CABG patients who are at high risk for incomplete revascularization.”

Board of Directors Additions

Joining Mr. King as a member of the XyloCor board of directors is Daniel Hétu, M.D., managing director, Lumira Ventures, and Perry Nisen, M.D., Ph.D., executive partner, Sofinnova Investments. Alan Colowick, M.D., MPH, will now serve an independent board member of XyloCor.

About XC001

XC001 is an investigational gene therapy designed to promote the growth of new blood vessels in the heart, with these new blood vessels bypassing diseased blood vessels and improving blood flow in the heart. XC001 deposits the gene for vascular endothelial growth factor (VEGF) in targeted heart cells. VEGF is a naturally occurring protein and it is believed that XC001 enables the heart cells to produce more VEGF, thus stimulating the creation of new blood vessels, a process called angiogenesis. XC001 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for study in refractory angina. An Investigational New Drug (IND) application for XC001 is open with the FDA. XyloCor commenced the EXACT Trial, a Phase 1/2 study of XC001 in chronic refractory angina in 2020.

The EXACT Trial

The EXACT clinical trial is a Phase 1/2 multicenter, open-label, single arm, dose escalation trial. Approximately 12 subjects (n=3 per cohort) who have refractory angina will be enrolled into 4 ascending dose groups, followed by an expansion phase of the trial with 21 additional subjects at the highest tolerated dose. The trial is designed to assess the safety and efficacy of XC001. The investigational gene therapy will be administered directly to the muscle tissue of the heart by an experienced cardiac surgeon. The EXACT Trial was initiated in 2020 and is ongoing at top cardiovascular research sites across the United States.

About Chronic Refractory Angina

Chronic angina pectoris occurs when the heart muscle does not receive as much oxygen as it needs for the amount of work it is performing, and this often results in chest pain. This is usually due to coronary artery disease. Patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and CABG have refractory angina and currently have no treatment options. These patients often become sedentary because of their symptoms, which in turn can exacerbate comorbidities and severely impact quality of life causing further deterioration of their health status. An estimated one million people suffer from refractory angina in the United States.

About Coronary Artery Bypass Graft Surgery (CABG)

CABG is a procedure used to treat coronary artery disease — the narrowing or blockage of the blood vessels that supply oxygen and nutrients to the heart muscle. During CABG, a healthy artery or vein from the body is connected, or grafted, to the blocked coronary artery. The grafted artery or vein bypasses the blocked portion of the coronary artery. This creates a new passage, and oxygen-rich blood is routed around the blockage to the heart muscle. Approximately 500,000 CABG procedures are performed annually in the United States, in which an estimated one-third of patients are at risk for incomplete coronary revascularization, often resulting in persistent angina. An adjunctive treatment to CABG, such as gene therapy with XC001, may reduce the incidence of incomplete revascularization.

About XyloCor

XyloCor Therapeutics is a biopharmaceutical company focused on the development of novel gene therapy for unmet needs in advanced coronary artery disease. In the United States, coronary artery disease is a leading cause of death and disability. The company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor also has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co‑founded by Ronald Crystal, MD, and Todd Rosengart, MD, has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Media Contact

Mike Beyer
Sam Brown Inc. Healthcare Communications
mikebeyer@sambrown.com
312-961-2502

TORONTO, ON / ACCESSWIRE / March 9, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that it has completed enrollment of the first cohort of a Phase 2b clinical study evaluating the company’s drug candidate EB01 as a monotherapy for chronic Allergic Contact Dermatitis (ACD), a potentially debilitating condition and occupational illness.

Edesa reported that all 46 subjects in the first cohort have been randomized and dosed with either Edesa’s EB01 topical treatment or a placebo cream. EB01 contains a non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. Since EB01 is designed to inhibit the inflammatory process at its inception rather than after inflammation has occurred, the company believes that the drug could potentially exert a powerful anti-inflammatory effect without the safety concerns of steroids.

Once all the subjects in the first cohort complete the 28-day treatment, Edesa plans to initiate a blinded interim analysis. The interim results will determine the number of patients for the final part of the Phase 2b study based on probability thresholds previously approved by the Food and Drug Administration. In two previous clinical studies EB01 has demonstrated statistically significant improvement of multiple symptoms in ACD patients.

Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa, said that the company is grateful to the patients, physicians and research staff for their participation and diligent work despite the challenges presented by the pandemic.

“We are encouraged by the strong interest in the program. Should the blinded analysis confirm that the probability of success meets or exceeds the predetermined thresholds, we plan to move rapidly into the final part of the study,” said Dr. Nijhawan. He noted that enrollment activities for the second half of the Phase 2b study would continue during the interim analysis period.

Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States. The disease has been estimated to cost up to $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with academic literature pointing to a potentially larger undiagnosed population. More than 1 million patients are estimated to have chronic ACD. To the company’s knowledge, there are currently no treatment options specifically labelled for ACD.

Physicians interested in participating in the study should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT03680131).

About Edesa Biotech, Inc.
Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. EB01 employs a novel, non-steroidal mechanism of action and in two clinical studies has demonstrated statistically significant improvement of multiple symptoms in ACD patients. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts.

Edesa Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s plans regarding its Phase 2b clinical study, including its plans to initiate a blinded interim analysis, and the company’s belief that EB01 could potentially exert a powerful anti-inflammatory effect without the safety concerns of steroids. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as COVID-19. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

CONTACT:
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
investors@edesabiotech.com

SOURCE: Edesa Biotech

Fusion to Leverage its Targeted Alpha Therapies (TAT) Expertise to Create FPI-2059, an Alpha-Emitting Radiopharmaceutical Targeting Solid Tumors

HAMILTON, ON and BOSTON, March 2, 2021 /PRNewswire/ — Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced it has entered into an asset purchase agreement (APA) to acquire Ipsen’s (Euronext: IPN; ADR; IPSEY) intellectual property and assets related to IPN-1087. IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types.  Fusion intends to use IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1. 

“The acquisition of IPN-1087 augments and further diversifies our pipeline of potent alpha-emitting radiopharmaceuticals and leverages our expertise to create targeted alpha therapies (TATs) using different classes of targeting molecules,” said Chief Executive Officer John Valliant, Ph.D. “In clinical imaging studies, IPN-1087, which targets an established tumor target, has shown uptake in multiple tumor types. Combining IPN-1087 with the power of actinium-225, an alpha-emitter, we believe FPI-2059 will precisely target and kill tumor cells, leading to a significant opportunity to advance the treatment of high unmet need diseases, such as colorectal cancer and pancreatic ductal adenocarcinoma (PDAC).”

Under the terms of the APA, Fusion will issue to Ipsen 400,000 shares of its common stock upon closing and an additional 200,000 shares upon the achievement of a patent-related milestone. Such shares will be issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended. Fusion will also be obligated to pay Ipsen up to an additional €67.5 million upon the achievement of certain development and regulatory milestones; low single-digit royalties on potential future net sales; and up to €350.0 million in net sales milestones, in each case, relating to products covered by the APA. Fusion will be responsible for paying to a third-party licensor up to €70.0 million in development milestone payments and mid-single to low-double-digit royalties on potential future net sales of products covered by the license agreement.

Covington & Burling and Goodwin Proctor represented Fusion as legal advisors in the transaction. Barclays represented Ipsen as exclusive financial advisor and Hogan Lovells acted as Ipsen’s legal advisor.

About FPI-2059
FPI-2059 will be a radioconjugate combining actinium-225 with IPN-1087, for development as a targeted alpha therapy for various solid tumors. The molecule targets NTSR1, a promising target for cancer treatment, that is overexpressed in multiple solid tumors.  IPN-1087 was in Phase 1 clinical development as a lutetium-177-based radiopharmaceutical for pancreatic ductal adenocarcinoma, colorectal cancer and gastric cancers expressing NTSR1.

About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion’s lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform technology.

About Ipsen
Ipsen is a global mid-size biopharmaceutical company with a focus on transformative medicines in Oncology, Rare Disease and Neuroscience. Ipsen also has a well-established Consumer Healthcare business. With total sales over €2.5 billion in 2020, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen’s R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US; Shanghai, China). The Group has about 5,700 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.fr

Forward Looking Statements

This press release contains “forward-looking statements” for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding Fusion Pharmaceuticals Inc.’s (the “Company”) future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “expect,” “plans,” “anticipates,” “intends,” “will,” and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company’s potential drug candidates, including any expressed or implied statements regarding the successful development of FPI-2059; the likelihood and success of any future clinical trials involving FPI-2059 or any novel Targeted Alpha Therapies; and the expected benefits of the acquisition of IPN-1087. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management’s expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company’s ability to obtain additional funding required to conduct its research, development and commercialization activities; changes in the Company’s business plan or objectives; the ability of the Company to attract and retain qualified personnel; competition in general; and the Company’s ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management’s expectations are described in greater detail under the heading “Risk Factors” in the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2020 as filed with the SEC and in any subsequent periodic or current report that the Company files with the SEC. All forward-looking statements reflect the Company’s estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company’s views, expectations or beliefs at any date subsequent to the date of this release. While Fusion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company’s estimates change.

SOURCE Fusion Pharmaceuticals Inc.

For further information: Amanda Cray, Senior Director of Investor Relations & Corporate Communications, 617-420-5698, cray@fusionpharma.com

Launch of Innovative Therapy for People Living with Extensive-Stage Small Cell Lung Cancer is Supported by the G1 to One™ Patient Support Program, the Single Source for COSELA Access Solutions

RESEARCH TRIANGLE PARK, N.C. and RIDGEFIELD, Conn., March 02, 2021 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX) and Boehringer Ingelheim today announced that COSELA™ (trilaciclib) for injection is now available in the U.S. On February 12, 2021, the U.S. Food and Drug Administration (FDA) approved COSELA to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). It is the first and only therapy designed to help protect bone marrow (myeloprotection) when administered prior to treatment with chemotherapy.

“This is an exciting time for the combined G1 and Boehringer Ingelheim team as we are now able to provide COSELA, the first proactive multilineage myeloprotection therapy, to patients with extensive-stage small cell lung cancer,” said Soma Gupta, Chief Commercial Officer at G1 Therapeutics. “Our commitment includes ensuring excellence in support and access to COSELA; to that end, we are excited to launch the G1 to One Patient Support Program which is designed to provide access and affordability solutions to eligible patients.”

“We are proud to help bring COSELA to the physicians and their patients who are in need of options when it comes to managing ES-SCLC treatment,” said Dan Asch, Head of Commercial Oncology at Boehringer Ingelheim Pharmaceuticals, Inc. “G1’s experienced and passionate commercial and medical teams along with Boehringer Ingelheim’s seasoned oncology team are eager to engage with the community to communicate the clinical benefits of this innovative therapy.”

“Because ES-SCLC cannot be cured, the goals of treatment are increased life expectancy and improved quality of life; most patients prioritize quality of life, but clinicians have very few tools to do this,” said Jared Weiss, MD, Associate Professor of Medicine, Division of Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina Chapel Hill, NC. “Chemotherapy can result in potentially debilitating side effects, many of which are hematologically driven, such as severe low white blood cell counts (neutropenia) and anemia, which can cause fatigue. Doctors accept these side effects because we lack tools to help prevent them. COSELA (trilaciclib) provides the first proactive approach to help protect against myelosuppression through a unique mechanism of action that helps proactively protect the bone marrow from damage when given prior to chemotherapy.”

Chemotherapy is an effective and important weapon against cancer. However, chemotherapy does not differentiate between healthy cells and cancer cells. It kills both, including important hematopoietic stem and progenitor cells (HSPCs) in the bone marrow that produce white blood cells (immune cells that help fight infection), red blood cells (cells that carry oxygen from the lungs to the tissues), and platelets (cells that prevent bleeding from cancer, surgeries, chronic diseases, and injuries). Chemotherapy-induced bone marrow damage, known as myelosuppression, can lead to increased risk of infection, anemia, thrombocytopenia, and other complications. Myeloprotection is a novel approach to protect HSPCs in the bone marrow from chemotherapy-induced damage. This approach can help reduce some chemotherapy-related toxicities, which helps make chemotherapy safer and more tolerable, while also reducing the need for reactive rescue interventions.

COSELA is available through the following specialty distributors: Amerisource Specialty Distribution, Oncology Supply, McKesson Plasma and Biologics, McKesson Specialty and Cardinal Specialty. COSELA is expected to be widely covered by insurance plans.

The G1 to One™ Patient Support Program offers a suite of solutions to address common access and reimbursement challenges, such as benefits verification for patient coverage and out-of-pocket costs. The program provides payor-specific guidance for prior authorizations and appeals to address patient needs; offering solutions for insurance-related delays and connecting patients, regardless of insurance type, to appropriate resources that can address high deductibles, co-pays/co-insurance, or lack of coverage when certain eligibility requirements are met. For more information, patients and providers can call G1 to One at 833-G1toONE (833-418-6663) from 8:00 AM to 8:00 PM Eastern time.

About COSELA™ (trilaciclib)

COSELA™ (trilaciclib) is the first and only myeloprotection therapy to help decrease the incidence of chemotherapy-induced myelosuppression. Administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy, COSELA helps proactively deliver multilineage myeloprotection to patients with extensive-stage small cell lung cancer (ES-SCLC) being treated with chemotherapy. COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC.

For more information about COSELA visit www.cosela.com.

COSELA (trilaciclib) Co-Promotion Agreement with Boehringer Ingelheim

In June 2020, G1 announced a three-year co-promotion agreement with Boehringer Ingelheim for COSELA in small cell lung cancer in the U.S. and Puerto Rico. G1 will lead marketing, market access and medical engagement initiatives for COSELA. The Boehringer Ingelheim oncology commercial team, well-established in lung cancer, will lead sales force engagement initiatives. G1 will book revenue and retain development and commercialization rights to COSELA and pay Boehringer Ingelheim a promotional fee based on net sales. The three-year agreement does not extend to additional indications that G1 is evaluating for trilaciclib. Press release details of the G1/Boehringer Ingelheim agreement can be found here.

About Small Cell Lung Cancer

In the U.S., approximately 30,000 small cell lung cancer patients are treated annually. SCLC, one of the two main types of lung cancer, accounts for about 10% to 15% of all lung cancers. SCLC is an aggressive disease and tends to grow and spread faster than NSCLC. It is usually asymptomatic; once symptoms do appear, it often indicates that the cancer has spread to other parts of the body. About 70% of people with SCLC will have cancer that has metastasized at the time they are diagnosed. The severity of symptoms usually increases with increased cancer growth and spread. From the time of diagnosis, the general five-year survival rate for people with SCLC is 6%. The five-year survival rates for limited-stage (the cancer is confined to one side of the chest) SCLC is 12% to 15%; and for extensive stage (ES; cancer has spread to the other lung and beyond), survival rates are less than 2%. Chemotherapy is the most common treatment for ES-SCLC.

COSELA™ (trilaciclib) for Injection  

INDICATION

COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

• COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

WARNINGS AND PRECAUTIONS

Injection-Site Reactions, Including Phlebitis and Thrombophlebitis

• COSELA administration can cause injection-site reactions, including phlebitis and thrombophlebitis, which occurred in 56 (21%) of 272 patients receiving COSELA in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions. Monitor patients for signs and symptoms of injection-site reactions, including infusion-site pain and erythema during infusion. For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue COSELA. Injection-site reactions led to discontinuation of treatment in 3 (1%) of the 272 patients.

Acute Drug Hypersensitivity Reactions

• COSELA administration can cause acute drug hypersensitivity reactions, which occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). Monitor patients for signs and symptoms of acute drug hypersensitivity reactions. For moderate (Grade 2) acute drug hypersensitivity reactions, stop infusion and hold COSELA until the adverse reaction recovers to Grade ≤1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue COSELA.

Interstitial Lung Disease/Pneumonitis

• Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, including COSELA, with which it occurred in 1 (0.4%) of 272 patients receiving COSELA in clinical trials. Monitor patients for pulmonary symptoms of ILD/pneumonitis. For recurrent moderate (Grade 2) ILD/pneumonitis, and severe (Grade 3) or life-threatening (Grade 4) ILD/pneumonitis, permanently discontinue COSELA.

Embryo-Fetal Toxicity

• Based on its mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with COSELA and for at least 3 weeks after the final dose.

ADVERSE REACTIONS

• Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis.
• Fatal adverse reactions were observed in 5% of patients receiving COSELA. Fatal adverse reactions for patients receiving COSELA included pneumonia (2%), respiratory failure (2%), acute respiratory failure (<1%), hemoptysis (<1%), and cerebrovascular accident (<1%).
• Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA. Adverse reactions leading to permanent discontinuation of any study treatment for patients receiving COSELA included pneumonia (2%), asthenia (2%), injection-site reaction, thrombocytopenia, cerebrovascular accident, ischemic stroke, infusion-related reaction, respiratory failure, and myositis (<1% each).
• Infusion interruptions due to an adverse reaction occurred in 4.1% of patients who received COSELA.
• The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

DRUG INTERACTIONS

• COSELA is an inhibitor of OCT2, MATE1, and MATE-2K. Co-administration of COSELA may increase the concentration or net accumulation of OCT2, MATE1, and MATE-2K substrates in the kidney (e.g., dofetilide, dalfampridine, and cisplatin).

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information here.

For more information about COSELA, please call 1-800-790-G1TX (1-800-790-4189) or visit www.cosela.com.

About G1 Therapeutics

G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA™ (trilaciclib). G1 has a deep clinical pipeline evaluating targeted cancer therapies in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

G1 Therapeutics™ and the G1 Therapeutics logo, COSELA™ and the COSELA logo, G1 to One™ and the G1 to One logo are trademarks of G1 Therapeutics, Inc.

About Boehringer Ingelheim in Oncology

Cancer takes. Takes away time. Takes away loved ones. At Boehringer Ingelheim Oncology, we are giving patients new hope, by taking cancer on. We are dedicated to collaborating with the oncology community on a shared journey to deliver leading science. Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immuno-oncology therapies and intelligent combination approaches to help combat many cancers.

About Boehringer Ingelheim

Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.

For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, COSELA’s (trilaciclib) possibility to improve patient outcomes, COSELA may fail to achieve the degree of market acceptance for commercial success, and are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the company’s dependence on the commercial success of COSELA; the development and commercialization of new drug products is highly competitive; the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact: Will Roberts
G1 Therapeutics, Inc.
Vice President, Investor Relations and Corporate Communications
(919) 907-1944
wroberts@g1therapeutics.com

LISLE, IL – MARCH 2, 2021 – Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the appointment of seasoned medical device industry executive Dan Dearen to its Board of Directors. Mr. Dearen currently serves as the President and Chief Financial Officer of Axonics Modulation Technologies, Inc. (Nasdaq: AXNX), a medical technology company he helped take public in 2018 with sales in 2020 of over $111 million and a current market capitalization of $2 billion. Mr. Dearen joins the Endotronix Board as an Independent Director and will serve as Chair of the Audit Committee.

“We welcome Dan’s healthcare experience and leadership as Endotronix prepares for commercial growth and rapid expansion,” said Paul LaViolette, Managing Partner at SV Health Investors and Chairman of the Board. “Dan’s extensive track record of building best-in-class organizations, establishing rigorous financial frameworks, and scaling businesses will be invaluable during this next phase of Endotronix’s growth.”

Mr. Dearen brings more than three decades of executive leadership experience in the medical device and life sciences industries. He co-founded Axonics and has served in his current role for over seven years, during which time the company developed, obtained FDA approval for, and launched its sacral neuromodulation system to treat overactive bladder, acquired Bulkamid to treat stress urinary incontinence, and raised $138 million in its 2018 IPO plus $267 million through two subsequent equity offerings. Previously, Mr. Dearen was the Chief Operating and Financial Officer of Vessix Vascular through the acquisition and integration into Boston Scientific for $425 million in 2012. He also served as Chief Financial Officer of Miraval Holding, Q3DM (acquired by Beckman Coulter), Medication Delivery Devices (acquired by Baxter Healthcare) and was a Principal at Ventana Growth Funds, an international venture capital firm. Mr. Dearen started his career as a CPA in the healthcare group at Ernst & Young. He holds a BBA in Accounting & Business from Southern Methodist University and an MBA from Boston College.

“I have had the pleasure of following the team’s progress and am impressed by the growing data demonstrating the value of the Cordella System,” commented Mr. Dearen. “I am excited to join Endotronix as the company prepares for commercial launch and rapid growth in this duopoly interventional heart failure segment, pulmonary artery (PA) pressure-guided HF management. And I look forward to leveraging my diverse experiences to accelerate the company along its mission to transform the standard of care for chronic heart failure patients.”

The Cordella™ Heart Failure System from Endotronix is a comprehensive heart failure management solution that enables proactive management and early detection of worsening heart failure. The platform consists of a comprehensive remote patient management system with non-invasive daily health metrics that seamlessly integrates a next generation implantable pulmonary artery pressure sensor to streamline heart failure care management, reduce heart-failure-related hospitalizations, and support reimbursement for care delivery.

Endotronix is actively enrolling heart failure patients in PROACTIVE-HF, their U.S. investigational device exemption (IDE) clinical trial, and SIRONA II, their CE Mark clinical trial. The studies seek to demonstrate the benefits of PA pressure-guided therapy for the remote management of chronic heart failure patients and provide market access for the Cordella™ PA Sensor. Full trial enrollment remains a core focus as the company plans for commercial launch of the Cordella PA sensor.

About Endotronix

Endotronix, Inc., a medical technology company, delivers an integrated platform that provides comprehensive, reimbursable health management innovations for patients suffering from advanced heart failure. Their solution, the Cordella™ Heart Failure System, includes a cloud-based disease management data system and at home hemodynamic management with a breakthrough implantable wireless pulmonary artery pressure sensor for early detection of worsening heart failure.  Learn more at www.endotronix.com.

The Cordella System, without the sensor, is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S. The Cordella PA Sensor is currently under clinical investigation in Europe (SIRONA II CE Mark Trial) and the U.S. (PROACTIVE-HF IDE Trial) and is not currently available for commercial use in any geography.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain predictions, estimates or other information that might be considered forward- looking statements. Such forward-looking statements are not a guarantee of future performance.

MEDIA CONTACT:
Carla Benigni
Sprig Consulting, LLC
+1 (847) – 951 – 7430
carla@sprigconsulting.com

Management to host conference call at 8:00 AM Eastern Time on Tuesday, March 2, 2021

TORONTO, CHICAGO and MONTREAL, March 01, 2021 (GLOBE NEWSWIRE) — Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP) (OTCQX: MEDXF) (Frankfurt: P731) today announced its financial and operating results for the three and nine months ended December 31, 2020. All dollar amounts below are in Canadian dollars unless specified otherwise.

Third Quarter Fiscal 2021 Financial Highlights:

• The Company achieved record revenue of $31.5 million for the three-month period ended December 31, 2020, versus $16.2 million for the same period last year. As previously reported, the revenue for the period included approximately $3 million in IXINITY® revenues, which were originally expected to be realized in September 2020, but were instead realized in October 2020 due to a delay in receipt of finished product from the Company’s contract manufacturing partner.
• Adjusted EBITDA* increased to $5.1 million compared to $0.7 million for the same period last year. Adjusted EBITDA* was also positively impacted by the delayed October shipment of IXINITY®.
• With the significant share price appreciation in the quarter, the non-cash fair value of the derivative associated with the conversion rights of the existing debentures increased materially to $16.5 million. This increase in fair value of derivatives was the primary driver for the reported net loss of $17.1 million compared to $2.6 million for the same period last year. On a year over year basis, the Adjusted Net Loss* improved by$4.7 million to $0.5 million as compared to $5.2 million.
• Operating income improved by $5.3 million to $2.0 million, compared to an operating loss of $3.3 million for the same period last year.

Ken d’Entremont, Chief Executive Officer of Medexus, noted, “The fiscal third quarter of 2021 was a record quarter with $31.5 million in revenue. We continued to generate solid growth while managing our expenses and the $5.3 million improvement in operating income was a strong reflection of that. Our $82.7 million in revenue for the first nine months of Fiscal 2021 reflects a 70% increase over the previous year and achieved strong Adjusted EBITDA* performance of a more than six-fold increase over the previous year. With a strong base of

revenues from Rasuvo®, IXINITY® Metoject® and Rupall, we believe that the recent additions to our portfolio will become major drivers of our growth going forward. Subsequent to the end of the quarter, we completed a transformative licensing deal for treosulfan in the United States and materially enhanced our ability to fund our growth initiatives, with the completion of an oversubscribed financing of $32.5 million. In the coming quarters we will continue to invest in our business, putting in place the people and infrastructure required to support the launch of treosulfan. This investment will be the key to supporting and enabling the significant revenue growth that we expect from treosulfan. Despite this material addition to our product portfolio, the quality of our in-licensing opportunities continues to broaden and deepen and we are working diligently to prioritize and pursue those that will best enable us to further leverage our North American commercial infrastructure. Finally, we are working to achieve a Nasdaq listing which should provide us much greater exposure to the broader North American investment community as we execute on key initiatives.

Operational Highlights**:

Bought Deal Public Offering: On February 23, 2021, the Company completed a bought deal public offering by way of a short form prospectus in Canada, including the full exercise of an over-allotment option, at a price of $7.10 per unit, representing aggregate gross proceeds to the Company of approximately $32.5 million; the offering was conducted by a syndicate of underwriters led by Raymond James Ltd. and Stifel Nicolaus Canada Inc.
Treosulfan: On February 2, 2021, the Company entered into an exclusive license to commercialize treosulfan in the United States. The Prescription Drug User Fee Act date is scheduled for August 2021 with potential to commercialize shortly thereafter. In accordance with the Orphan Drug Act, seven years of exclusivity for this indication is expected upon FDA approval. The current market leading alkylating agent for Allo-HSCT reached peak sales of US$126M in the U.S. As announced by the Company on September 10, 2020, Health Canada granted priority review for treosulfan, which could be approved as early as June 2021. Medexus is currently negotiating the license in anticipation of a full commercial launch following Health Canada approval.
IXINIT®: The Company has now enrolled more than 73% of patients for its ongoing Phase 4 clinical trial for IXINITY® to evaluate the safety and efficacy of IXINITY® in previously treated patients for a pediatric indication.
Gleolan®: On February 25, 2021, Medexus initiated commercial launch of Gleolan® in Canada, replacing use under the Health Canada Special Access Program.
Triamcinolone Hexacetonide (TH): On December 18, 2020, Medexus entered into an exclusive agreement to register and commercialize TH in the United States. The Company is in discussions with FDA regarding the drug shortage and anticipates receipt of a special import authorization for TH prior to seeking approved marketing authorization.
Nasdaq Application: On January 21, 2021, the Company announced that it had submitted its application to list its common shares on the Nasdaq. The listing of its common shares on the Nasdaq remains subject to the approval of the Nasdaq and the satisfaction of all applicable listing and regulatory requirements.

Operating and Financial Results Summary for the Three-Months Ended December 31, 2020
The Company achieved record revenue of $31.5 million for the three-month period ended December 31, 2020, versus $16.2 million for the three-month period ended December 31, The increase was mainly due to the acquisition of IXINITY® as well as unit demand growth of the Company’s key products in the market over the period.
Adjusted EBITDA* increased to $5.1 million compared to $0.7 million for the same period last year.
Net loss was $17.1 million compared to $2.6 million for the same period last year. Adjusted Net Loss* was $0.5 million compared to $5.2 million for the same period last year.
Achieved operating income of $2.0 million, compared to an operating loss of $3.3 million for the same period last year.
Operating and Financial Results Summary for the Nine-Months Ended December 31, 2020
Total revenue reached $82.7 million for the nine-month period ended December 31, 2020, compared to revenue of $48.7 million for the nine-month period ended December 31, 2019,
as a result of the acquisition of IXINITY® as well as unit demand growth of the Company’s key products in the market over the period.
Adjusted EBITDA* for the nine-month period ended December 31, 2020 increased to $13.1 million compared to $1.8 million for the nine-month period ended December 31, 2019.
Net loss for the nine-month period ended December 31, 2020 was $23.9 million, compared to net loss of $4.1 million for same period last year. Adjusted Net Loss* was $3.3 million compared to $11.7 million for the same period last year.
Selling and administrative expenses as a percentage of revenue decreased to 41.8%, from 62.4% for the same period last year, as the Company continues to leverage its platform and significantly increase its revenue with only modest increases to operating expenses.
Achieved operating income of $4.2 million, compared to an operating loss of $5.8 million for the same period last year.
Available liquidity of $15.2 million at December 31, 2020, compared to $7.4 million at March 31, 2020.
The Company’s financial statements and management discussion and analysis (“MD&A”) for the period ended December 31, 2020 are available on our corporate website at www.medexus.com and in our corporate filings on SEDAR at www.sedar.com.

Refer to Non-IFRS Financial Measures at the end of this press release.
** Refer to Cautionary Note Regarding Comparative Financial Information at the end of this press release.

Conference Call Details:
Medexus will host a conference call at 8:00 AM Eastern Time on Tuesday, March 2, 2021 to discuss the Company’s financial results for the fiscal 2021 third quarter ended December 31, 2020, as well as the Company’s corporate progress and other developments.

The conference call will be available via telephone by dialing toll free 888-506-0062 for Canadian and U.S. callers or +1 973-528-0011 for international callers and using entry code 414918. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2010/40181 or on the Company’s Investor Events section of the website: https://www.medexus.com/en_US/investors/news-events.

A webcast replay will be available on the Company’s Investor Events section of the website (https://www.medexus.com/en_US/investors/news-events) through Wednesday, June 2, 2021. A telephone replay of the call will be available approximately one hour following the call, through Tuesday, March 9, 2021 and can be accessed by dialing 877-481-4010 for Canadian and U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 40181.

About Medexus Pharmaceuticals Inc.
Medexus is a leader in innovative rare disease treatment solutions with a strong North American commercial platform. From a foundation of proven best in class products we are building a highly differentiated company with a portfolio of innovative and high value orphan and rare disease products that will underpin our growth for the next decade. The Company’s vision is to provide the best healthcare products to healthcare professionals and patients, through our core values of Quality, Innovation, Customer Service and Teamwork. Medexus Pharmaceuticals is focused on the therapeutic areas of auto-immune disease, hematology, and allergy. The Company’s leading products are: Rasuvo and Metoject®, a unique formulation of methotrexate (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; IXINITY, an intravenous recombinant factor IX therapeutic for use in patients 12 years of age or older with Hemophilia B “ a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood, which is
necessary to control bleeding; and Rupall®, an innovative prescription allergy medication with a unique mode of action.
For more information, please contact:

Ken d’Entremont, Chief Executive Officer
Medexus Pharmaceuticals Inc.
Tel.: 905-676-0003
E-mail: ken.dentremont@medexus.com
Roland Boivin, Chief Financial Officer
Medexus Pharmaceuticals Inc.
Tel.: 514-344-8675 E-mail: roland.boivin@medexus.com

Investor Relations (U.S.):
Crescendo Communications, LLC
Tel: +1-212-671-1020
E-mail: mdp@crescendo-ir.com

Investor Relations (Canada):
Tina Byers
Investor Relations
Tel: 905-330-3275
E-mail: tina@adcap.ca

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Cautionary Note Regarding Comparative Financial Information
On February 28, 2020, the Company announced that it had, indirectly through its wholly-owned subsidiary, Medexus Pharma Inc. completed a major acquisition (the “2020 Acquisition”) in acquiring all of the outstanding limited liability company interests of Aptevo BioTherapeutics LLC, a Delaware limited liability company, from Aptevo Therapeutics, Inc. pursuant to a purchase agreement dated February 28, 2020.

Accordingly, readers are cautioned that while certain financial information included herein for, and comparisons to, prior periods have been presented in this press release, changes from a pre-2020 Acquisition period to a post-2020 Acquisition period may, in the opinion of management, be of limited value in understanding changes to the financial condition, financial performance, or business of the Company from period to period given the transformative nature of the 2020 Acquisition. Readers are advised that the comparative information included in this press release for the three- and nine-month periods ended December 31, 2019, includes only pre-2020 Acquisition results for the Company (i.e., the comparative information for such periods consists of (i) results prior to February 28, 2020, which reflect only the pre-2020 Acquisition results for the Company, and (ii) results subsequent to February 28, 2020, which reflect the consolidated results of the Company post-2020 Acquisition).

Forward-Looking Statements
Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws (“forward-looking statements”). The words “anticipates”, “believes”, “expects”, “will”, “plans” and similar expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Specific forward-looking statements contained in this news release include, but are not limited to, statements with respect to the Company’s future expectations regarding growth and increased investment in the Company’s portfolio; expectations regarding the Company’s ability to fund planned initiatives; expectations regarding the approval, commercialization and launch of treosulfan in the United States and the benefits from the Treosulfan licensing deal; expectations regarding a commercial launch of the Treosulfan in Canada; expected results and likelihood of approval of the Company’s Nasdaq listing application; and the anticipated receipt of a special import authorization for TH prior to seeking approved marketing authorization. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include those set out in the Company’s materials filed with the Canadian securities regulatory authorities from time to time, including the Company’s most recent annual information form and management’s discussion and analysis; future capital requirements and dilution; intellectual property protection and infringement risks; competition (including potential for generic competition); reliance on key management personnel; the Company’s ability to implement its business plan; the Company’s ability to leverage its United States and Canadian infrastructure to promote additional growth, including with respect to the infrastructure of Medexus Inc. and Medac Pharma, Inc. and the potential benefits the Company expects to derive therefrom; regulatory approval by the Canadian health authorities; product reimbursement by third party payers; patent litigation or patent expiry; litigation risk; stock price volatility; government regulation; and potential third party claims. Given these risks, undue reliance should not be placed on these forward-looking statements, which apply only as of the date hereof. Other than as specifically required by law, the Company undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

Non-IFRS Financial Measures
This press release uses the terms “Adjusted Net Income (Loss)” and “Adjusted EBITDA” which are non-IFRS financial measures, which do not have any standardized meaning prescribed by IFRS and are therefore unlikely to be comparable to similar measures presented by other companies. Rather, these measures are provided as additional information to complement those IFRS measures by providing further understanding of the Company’s results of operations from management’s perspective. Accordingly, they should not be considered in isolation nor as a substitute for analysis of the Company’s financial information reported under IFRS. In particular, management uses Adjusted Net Income (Loss) and Adjusted EBITDA as measures of the Company’s performance. The Company defines Adjusted Net Income (Loss) as net income (loss) before unrealized loss (gain) on fair value of derivatives. The Company defines Adjusted EBITDA as earnings before financing and special transaction costs (including, for greater certainty, fees related to the 2020 Acquisition and related financing), interest expenses, income taxes, interest income, depreciation of property and equipment, amortization of intangible assets, non-cash share-based compensation, income from sale of assets, gain or loss on the convertible debenture embedded derivative, foreign exchange gains or losses, termination benefits, and impairment of intangible assets. The Company considers Adjusted Net Income (Loss) and Adjusted EBITDA as key metrics in assessing business performance and considers Adjusted EBITDA to be an important measure of operating performance and cash flow, providing useful information to investors and analysts. These non-IFRS measures are not intended to represent cash provided by operating activities, net earnings or other measures of financial performance calculated in accordance with IFRS. Additional information relating to the use of these non-IFRS measures, including the reconciliation of each of Adjusted Net Income (Loss) and Adjusted EBITDA to Net Income (Loss), can be found in our MD&A, which is available through the SEDAR website (www.sedar.com).

Source: Medexus Pharmaceuticals Inc

SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) — Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) a clinical-stage biopharmaceutical company, today announced that it has agreed to sell 14,084,507 shares of its common stock to certain institutional investors in a private investment in public equity (PIPE) financing. The Company anticipates gross proceeds from the PIPE will be approximately $80 million, before deducting fees to the placement agents and other estimated offering expense payable by the Company, based on the offering price of $5.68 per share, the last reported sale price of our common stock on The Nasdaq Global Market on February 26, 2021.  The financing was led by Commodore Capital and New Enterprise Associates, L.P. with participation from new and existing investors including RA Capital Management, Vivo Capital, Samlyn Capital, Surveyor Capital (a Citadel company), Aspire Capital Fund, funds managed by Ghost Tree Capital Group, LP, Point72 Asset Management and Logos Capital as well as Satsuma co-founder, Shin Nippon Biomedical Laboratories, Ltd.

The financing is subject to standard closing conditions and the Company anticipates the closing to occur on March 3, 2021. In addition the financing was executed in compliance with applicable Nasdaq rules and priced at the “Minimum Price” (as defined in the Nasdaq rules).

SVB Leerink served as Satsuma’s exclusive financial advisor in connection with the PIPE financing.

“We are pleased to have the continued support of leading healthcare investors as we continue Phase 3 clinical development of STS101 as outlined in our separate press release also announced today,” said John Kollins, President & Chief Executive Officer of Satsuma. “We believe there is a compelling rationale for continuing development of STS101, and the proceeds from this financing better position us to deliver this potential migraine treatment to market.”

The securities sold in this private placement have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the U.S. except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Satsuma has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in these private placements.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Satsuma Pharmaceuticals and STS101

Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product candidate for the acute treatment of migraine. Its product candidate, STS101, is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, or DHE, which is designed to be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device. DHE products have long been recommended as a first-line therapeutic option for the acute treatment of migraine and have significant advantages over other therapeutics for many patients. However, broad use has been limited by invasive and burdensome administration and/or sub-optimal clinical performance of available injectable and liquid nasal spray products. STS101 is in Phase 3 development and specifically designed to deliver the clinical advantages of DHE while overcoming these shortcomings.

Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com.

Cautionary Note on Forward-Looking Statements

This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements. Accordingly, you should not rely on any of these forward-looking statements, including statements regarding the size, timing or completion of the financing. Additional applicable risks and uncertainties include those identified in the Company’s current and future reports filed with the SEC, including its Quarterly Report on Form 10-Q filed with the SEC on November 10, 2020. The forward-looking statements contained in this press release are based on information currently available to Satsuma and speak only as of the date on which they are made. Satsuma does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise, except as required by law.

This press release discusses STS101, a product candidate that is in clinical development, and which has not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of STS101 for the therapeutic use for which STS101 is being studied.

INVESTOR AND CORPORATE CONTACTS:         

Corey Davis, PhD
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com

Tom O’Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.
tom@satsumarx.com

TORONTO, The Globe and Mail (Ontario Edition) – One of Canada’s most celebrated scientists is bringing her new discovery to market, a pain-reducing alternative to opioids.

AmacaThera Inc., spun out of a U of T lab, has raised millions from investors for discovery of gel that targets postoperative pain relief. One of Canada’s most celebrated scientists, Molly Shoichet, is stepping up plans to take a key discovery out of her lab and into the marketplace. On Monday, AmacaThera Inc., the third startup spun out of Dr. Shoichets University of Toronto lab, is announcing it has raised $10.3-million from investors in Canada, the United States and Europe to take its product an injectable gel that can improve post-surgery pain treatment into human safety trials this year.

Dr. Shoichet is chief science officer, while her former postdoctoral research student and co-founder, Michael Cooke, is chief executive officer. Dr. Shoichet holds the Canada Research Chair in Tissue Engineering and was Ontario’s first chief scientist. She has won two of Canada’s top science prizes the $1-million Gerhard Herzberg Canada Gold Medal for Science and Engineering in 2020 and the Killam Prize for engineering in 2017. “She’s the reason we did the deal,” said Peter van der Velden, managing general partner with Toronto’s Lumira Ventures. Which led the financing, backed by Viva BioInnovator, BDC Capital Women in Technology Venture Fund, Inveready, MBX Capital, CR Capital Management, StandUp Ventures and MaRS Investment Accelerator Fund.

The work out of that lab is truly transformative and she’s a leader in the space. We thought there was an opportunity to build an interesting platform company based on her core technology. Dr. Shoichet’s lab uses materials called hydrogels to surround and protect drugs or stem cells when injected in the body, enabling them time to do their job. Work from her lab has led to applications to treat cancer, strokes and blindness. AmacaThera’s core material is an invention licensed from the lab that combines hyaluronic acid, commonly used in anti-wrinkle cosmetics, and methyl cellulose, which turns into a gel when heated. On its own, methyl cellulose gels at 90 C; combined with the acid, it does so at body temperature, making it usable in humans.

When existing drugs are mixed into the concoction, we can control how quickly they are released in the body, Dr. Shoichet said. I like to think of us as the FedEx of cells and drug delivery. FedEx provides the packaging and figures out how to get what’s inside where and when it needs to be there. AmacaThera’s initial target is postoperative pain relief. Doctors typically use local anesthetics such as bupivacaine for surgeries. But the drugs wear off in 12 to 18 hours, at which point opioids are prescribed for pain relief. Studies have shown that leads to millions of cases of opioid dependency annually. Dr. Shoichet and Mr. Cooke say they believe that if their hydrogel can hold and gradually release a larger dose of the anesthetic over three days, it can get post-surgical patients to the point where they don’t need opioids. That could improve pain management, cut hospital stays and reduce opioid addictions. The economic effect [would be] huge, and on top of that there’s the benefit to the patients and society, Mr. Cooke said.

Hance Clarke, an anesthetist who directs pain services at Toronto General Hospital, said a product for sale in the United States called Exparel can extend the anesthetic effect to 24 hours. There’s no doubt this would be a significant breakthrough if [AmacaThera] could come up with a therapeutic option lasting 72 hours after surgery. If they can get this across the finish line there’s certainly a home for this to land in clinical medicine. A growing number of research academics have warmed to the idea of commercializing their work in recent decades, although Canada has been slower to embrace the trend.

That was never the case for Toronto-born Dr. Shoichet, the daughter of two entrepreneurs, who worked early in her career at a U.S. biotech startup. She was keen to spin out inventions from her lab after starting at the University of Toronto in 1995, making her an anomaly at the time, she said. She was concerned her graduate students were leaving for the U.S. because there were very few opportunities here. So I became motivated to make a difference and help create more opportunities in Canada. The first startup spun out of her lab in 1998 was called BoneTec Corp. She sold her shares to co-founder John Davies three years later. In 2002, she founded MatRegen Corp. and served as president, raising more than $2-million before the company wound up in 2008. By the time she and Mr. Cooke co-founded AmacaThera in 2016, Dr. Shoichet had learned a few lessons as an entrepreneur: Keep early stage commercial technology in an academic setting as long as necessary and make your mistakes in as safe a place as possible.

The company also needed a full-time CEO she could trust, she said. She couldn’t fill that job herself and also run a lab, but Mr. Cooke, who had joined her lab in 2008 while pursuing his PhD, was game. AmacaThera, which raised US$1.8-million in seed funding in 2018, hopes to pass the safety trials and move to efficacy trials involving 100 post-surgical patients next year, Mr. Cooke said. The hope is that the technology can eventually be used to deliver a range of drugs, providing greater benefits with its time release properties. We really like that approach, said Michelle Scarborough, managing partner with the BDC fund. It solves a really big problem with a line of sight to commercial potential.

Source

Series B financing to support ongoing Phase 1/2a clinical trial of Tegavivint in desmoid tumors and initiation of clinical trials in acute myeloid leukemia, non-small cell lung cancer and pediatric cancers

HOUSTON, Feb. 16, 2021 /PRNewswire/ — Iterion Therapeutics, Inc. (“Iterion”), a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics, announced today that it has raised $17 million USD in a Series B financing led by Lumira Ventures, with the participation of existing investors, including Santé Ventures, as well as new investors Venture Investors, GPG Ventures, and Viva BioInnovator.

Iterion plans to utilize the proceeds from this financing to advance the development of its lead clinical candidate, Tegavivint, a novel, potent and selective nuclear beta-catenin inhibitor. Tegavivint is currently being investigated in a Phase 1/2a clinical trial in patients with desmoid tumors, which are rare, non-metastasizing sarcomas that overexpress nuclear beta-catenin. Iterion has received Orphan Drug Designation for Tegavivint to treat desmoid tumors, a disease for which there are no FDA approved therapies.

In addition to desmoid tumors, Iterion is preparing to initiate clinical programs in 2021 to investigate Tegavivint in acute myeloid leukemia (AML), non-small cell lung cancer (NSCLC), and pediatric cancers, including sarcomas, lymphoma and other solid tumors.  These cancers are often characterized by nuclear beta-catenin overexpression, providing potential high-value target expansions for Tegavivint.

“We envision incredible potential therapeutic benefits associated with Tegavivint, and are excited to support the Iterion team in its exploration of multiple clinical development opportunities for this potentially groundbreaking therapeutic,” said Benjamin Rovinski, Ph.D., Managing Director at Lumira Ventures. “2021 is expected to be a pivotal year for Iterion as the company anticipates initiating clinical trials in AML, NSCLC and pediatric cancers, all indications in which nuclear beta-catenin signaling plays a role. By pursuing a novel mechanism of action, we believe Tegavivint has the potential to overcome challenges faced by prior drugs targeting this pathway.”

Nuclear beta-catenin is a highly-studied oncology target associated with numerous cancer types. Tegavivint is unique among nuclear beta-catenin inhibitors in that it binds to TBL1 (Transducin Beta-like Protein One), a novel downstream target in the Wnt-signaling pathway. As such, Tegavivint enables silencing of Wnt-pathway gene expression without affecting other necessary Wnt/beta-catenin functions in the cell membrane, thus avoiding toxicity issues common to other drugs in this pathway.

“We are grateful to have the confidence of investors, including Lumira Ventures, Santé Ventures and others, that appreciate Tegavivint’s potential to treat a host of cancers,” said Rahul Aras, Ph.D., CEO of Iterion. “Nuclear beta-catenin has historically been considered an ‘undruggable’ oncology target with prior inhibitors having been plagued by toxicity issues, greatly limiting their therapeutic use.  Research suggests that these toxicity concerns can be negated by targeting TBL1, a novel downstream target in the Wnt-signaling pathway necessary for beta-catenin’s oncogenic activity.  This is precisely Tegavivint’s mechanism of action and why we believe the technology holds such substantial promise.”

Dr. Aras continued, “With the Series B funding, Iterion has the potential to significantly expand our clinical footprint through completion of our ongoing desmoid tumor study and initiate clinical trials in 2021 to investigate Tegavivint in AML, NSCLC, and certain pediatric cancers.”

About Iterion Therapeutics
Iterion Therapeutics is a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics. The company’s lead product, Tegavivint, is a potent and selective inhibitor of nuclear beta-catenin, a historically “undruggable” oncology target implicated in cell proliferation, differentiation, immune evasion and stem cell renewal. Research demonstrating potent anti-tumor activity in a broad range of pre-clinical models indicate that Tegavivint has the potential for clinical utility in multiple cancer types. Tegavivint is currently the subject of a Phase 1/2a clinical trial in patients with progressive desmoid tumors. Iterion is also pursuing clinical programs in additional cancers where nuclear beta-catenin signaling has been shown to play a role, including acute myeloid leukemia (AML), non-small cell lung cancer (NSCLC), and pediatric cancers, including sarcomas, lymphoma and other solid tumors. Iterion is the recipient of an up to $15.9 million Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information on Iterion, please visit https://iteriontherapeutics.com or follow the Company on Twitter and Linkedin.

Tiberend Strategic Advisors, Inc. 
Ingrid Mezo (Media)
646-604-5150
imezo@tiberend.com

SOURCE Iterion Therapeutics

COSELA is the only FDA-approved therapy that helps proactively deliver multilineage myeloprotection to patients with extensive-stage small cell lung cancer being treated with chemotherapy

– Myeloprotective efficacy of COSELA resulted in reductions in the incidence and duration of severe neutropenia, and impacted anemia and the need for rescue interventions such as growth factors and red blood cell transfusions –

– G1 will host conference call Tuesday, February 16, 2021 at 8:00 a.m. ET –

RESEARCH TRIANGLE PARK, N.C., Feb. 12, 2021 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved COSELA™ (trilaciclib) for injection to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). It is the first and only therapy designed to help protect bone marrow (myeloprotection) when administered prior to treatment with chemotherapy. COSELA is expected to be commercially available through G1’s specialty distributor partner network in early March.

“The approval of trilaciclib (COSELA) is an important advance in the treatment of patients with extensive-stage small cell lung cancer receiving chemotherapy,” said Dr. Jeffrey Crawford, Geller Professor for Research in Cancer in the Department of Medicine and Duke Cancer Institute. “The most serious and life-threatening side effect of chemotherapy is myelosuppression, or damage to the bone marrow, resulting in reduced white blood cells, red blood cells and platelets. Chemotherapy-induced myelosuppression may lead to increased risks of infection, severe anemia, and/or bleeding. These complications impact patients’ quality of life and may also result in chemotherapy dose reductions and delays. To date, approaches have included the use of growth factor agents to accelerate blood cell recovery after the bone marrow injury has occurred, along with antibiotics and transfusions as needed. By contrast, trilaciclib provides the first proactive approach to myelosuppression through a unique mechanism of action that helps protect the bone marrow from damage by chemotherapy. In clinical trials, the addition of trilaciclib to extensive-stage small cell lung cancer chemotherapy treatment regimens reduced myelosuppression and improved clinical outcomes. The good news is that these benefits of trilaciclib will now be available for our patients in clinical practice.”

Chemotherapy is an effective and important weapon against cancer. However, chemotherapy does not differentiate between healthy cells and cancer cells. It kills both, including important hematopoietic stem and progenitor cells (HSPCs) in the bone marrow that produce white blood cells (immune cells that help fight infection), red blood cells (cells that carry oxygen from the lungs to the tissues), and platelets (cells that prevent bleeding from cancer, surgeries, chronic diseases, and injuries). This chemotherapy-induced bone marrow damage, known as myelosuppression, can lead to increased risk of infection, anemia, thrombocytopenia, and other complications. Myeloprotection is a novel approach of protecting HSPCs in the bone marrow from chemotherapy-induced damage. This approach can help reduce some chemotherapy-related toxicity, making chemotherapy safer and more tolerable, while also reducing the need for reactive rescue interventions.

“Chemotherapy is the most effective and widely used approach to treating people diagnosed with extensive-stage small cell lung cancer; however, standard of care chemotherapy regimens are highly myelosuppressive and can lead to costly hospitalizations and rescue interventions,” said Jack Bailey, Chief Executive Officer at G1 Therapeutics. “COSELA will help change the chemotherapy experience for people who are battling ES-SCLC. G1 is proud to deliver COSELA to patients and their families as the first and only therapy to help protect against chemotherapy-induced myelosuppression.”

COSELA is administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy and is the first FDA-approved therapy that helps provide proactive, multilineage protection from chemotherapy-induced myelosuppression. The approval of COSELA is based on data from three randomized, placebo-controlled trials that showed patients receiving COSELA prior to the start of chemotherapy had clinically meaningful and statistically significant reduction in the duration and severity of neutropenia. Data also showed a positive impact on red blood cell transfusions and other myeloprotective measures. The trials evaluated COSELA in combination with carboplatin/etoposide (+/- the immunotherapy atezolizumab) and topotecan chemotherapy regimens. Approximately 90% of all patients with ES-SCLC will receive at least one of these regimens during the course of their treatment.

The majority of adverse reactions reported with COSELA were mild to moderate in severity. The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia. Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis. Grade 3/4 hematological adverse reactions occurring in patients treated with COSELA and placebo included neutropenia (32% and 69%), febrile neutropenia (3% and 9%), anemia (16% and 34%), thrombocytopenia (18% and 33%), and leukopenia (4% and 17%), respectively.

“Quite often, people diagnosed with extensive-stage small cell lung cancer rely on chemotherapy to not only extend their lives, but also to acutely alleviate their symptoms,” said Bonnie J. Addario, lung cancer survivor, co-founder and board chair of the Go2 Foundation for Lung Cancer. “Unfortunately, the vast majority will experience chemotherapy-induced side effects, resulting in dose delays and reductions, and increased utilization of healthcare services. G1 shares our organization’s goal to improve the quality of life of those diagnosed with lung cancer and to transform survivorship among people living with this insidious disease. We are thrilled to see new advancements that can help improve the lives of those living with small cell lung cancer.”

Approximately 30,000 small cell lung cancer patients are treated in the United States annually. G1 is committed to helping patients with extensive-stage small cell lung cancer in the U.S. gain access to treatment with COSELA. For more information on access and affordability programs, patients and providers should call the G1toOne support center at 833-G1toONE (833-418-6663) from 8:00 a.m. to 8:00 p.m. Eastern time.

G1 received Breakthrough Therapy Designation from the FDA in 2019 based on positive data in small cell lung cancer patients from three randomized Phase 2 clinical trials. As is common with breakthrough-designated products that receive priority review, G1 will conduct certain post-marketing activities, including in vitro drug-drug interaction and metabolism studies, and a clinical trial to assess impact of trilaciclib on disease progression or survival in patients with ES-SCLC with chemotherapy-induced myelosuppression treated with a platinum/etoposide-containing or topotecan-containing regimen with at least a two year follow up. G1 intends to initiate the post-approval clinical trial in 2022.

Webcast and Conference Call
The management team will host a webcast and conference call at 8:00 a.m. ET on Tuesday, February 16, 2021 to discuss the FDA approval of COSELA (trilaciclib). The live call may be accessed by dialing 866-763-6020 (domestic) or (210) 874-7713 (international) and entering the conference code: 6195528. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

COSELA (trilaciclib) Co-Promotion Agreement with Boehringer Ingelheim

In June 2020, G1 announced a three-year co-promotion agreement with Boehringer Ingelheim for COSELA in small cell lung cancer in the U.S. and Puerto Rico. G1 will lead marketing, market access and medical engagement initiatives for COSELA. The Boehringer Ingelheim oncology commercial team, well-established in lung cancer, will lead sales force engagement initiatives. G1 will book revenue and retain development and commercialization rights to COSELA and pay Boehringer Ingelheim a promotional fee based on net sales. The three-year agreement does not extend to additional indications that G1 is evaluating for trilaciclib. Press release details of the G1/ Boehringer Ingelheim agreement can be found here.

About Small Cell Lung Cancer

In the United States, approximately 30,000 small cell lung cancer patients are treated annually. SCLC, one of the two main types of lung cancer, accounts for about 10% to 15% of all lung cancers. SCLC is an aggressive disease and tends to grow and spread faster than NSCLC. It is usually asymptomatic; once symptoms do appear, it often indicates that the cancer has spread to other parts of the body. About 70% of people with SCLC will have cancer that has metastasized at the time they are diagnosed. The severity of symptoms usually increases with increased cancer growth and spread. From the time of diagnosis, the general 5-year survival rate for people with SCLC is 6%. The five-year survival rates for limited-stage (the cancer is confined to one side of the chest) SCLC is 12% to 15%, and for extensive stage (cancer has spread to the other lung and beyond), survival rates are less than 2%. Chemotherapy is the most common treatment for ES-SCLC.

COSELA™ (trilaciclib) for Injection  
INDICATION
COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

• COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

WARNINGS AND PRECAUTIONS

Injection-Site Reactions, Including Phlebitis and Thrombophlebitis

• COSELA administration can cause injection-site reactions, including phlebitis and thrombophlebitis, which occurred in 56 (21%) of 272 patients receiving COSELA in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions. Monitor patients for signs and symptoms of injection-site reactions, including infusion-site pain and erythema during infusion. For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue COSELA. Injection-site reactions led to discontinuation of treatment in 3 (1%) of the 272 patients.

Acute Drug Hypersensitivity Reactions

• COSELA administration can cause acute drug hypersensitivity reactions, which occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). Monitor patients for signs and symptoms of acute drug hypersensitivity reactions. For moderate (Grade 2) acute drug hypersensitivity reactions, stop infusion and hold COSELA until the adverse reaction recovers to Grade ≤1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue COSELA.

Interstitial Lung Disease/Pneumonitis

• Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, including COSELA, with which it occurred in 1 (0.4%) of 272 patients receiving COSELA in clinical trials. Monitor patients for pulmonary symptoms of ILD/pneumonitis. For recurrent moderate (Grade 2) ILD/pneumonitis, and severe (Grade 3) or life-threatening (Grade 4) ILD/pneumonitis, permanently discontinue COSELA.

Embryo-Fetal Toxicity

• Based on its mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with COSELA and for at least 3 weeks after the final dose.

ADVERSE REACTIONS

• Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis.
• Fatal adverse reactions were observed in 5% of patients receiving COSELA. Fatal adverse reactions for patients receiving COSELA included pneumonia (2%), respiratory failure (2%), acute respiratory failure (<1%), hemoptysis (<1%), and cerebrovascular accident (<1%).
• Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA. Adverse reactions leading to permanent discontinuation of any study treatment for patients receiving COSELA included pneumonia (2%), asthenia (2%), injection-site reaction, thrombocytopenia, cerebrovascular accident, ischemic stroke, infusion-related reaction, respiratory failure, and myositis (<1% each).
• Infusion interruptions due to an adverse reaction occurred in 4.1% of patients who received COSELA.
• The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

DRUG INTERACTIONS

• COSELA is an inhibitor of OCT2, MATE1, and MATE-2K. Co-administration of COSELA may increase the concentration or net accumulation of OCT2, MATE1, and MATE-2K substrates in the kidney (e.g., dofetilide, dalfampridine, and cisplatin).

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information here

For more information about COSELA, please call 1-800-790-G1TX (1-800-790-4189)

About G1 Therapeutics
G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercially available product COSELA™ (trilaciclib), a first-in-class therapy approved by the U.S. Food and Drug Administration to help protect against chemotherapy-induced myelosuppression in patients with extensive-stage small cell lung cancer being treated with chemotherapy. Trilaciclib is also being evaluated in other solid tumors, including colorectal, breast and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

Tecentriq® (atezolizumab) is a registered trademark of Genentech.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those relating to the therapeutic potential of COSELA (trilaciclib), and COSELA’s (trilaciclib) possibility to improve patient outcomes, are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contacts:
Will Roberts
G1 Therapeutics, Inc.
Vice President, Investor Relations and Corporate Communications
(919) 907-1944
wroberts@g1therapeutics.com

Christine Rogers
G1 Therapeutics, Inc.
Associate Director, Corporate Communications
(984) 365-2819
crogers@g1therapeutics.com

A PDF accompanying this announcement is available here

A photo accompanying this announcement is available here

ATLANTA, Feb. 11, 2021 (GLOBE NEWSWIRE) — Antios Therapeutics, Inc. (“Antios”) today announced the appointment of Patrick T. Higgins to the company’s board of directors. Mr. Higgins is a highly accomplished biopharmaceutical executive with more than two decades of experience leading companies in the development of therapies to treat infectious diseases of the liver including HBV and HCV.

“We have made significant progress on our lead asset, ATI-2173, a potential backbone treatment in a functional curative regimen for chronic HBV infection,” said Abel De La Rosa, Ph.D., co-founder of Antios and Chairman of its Board of Directors. “In conjunction with the completion of our Phase 1b clinical study in chronic HBV patients and with data expected to be presented at an upcoming medical conference, the addition of Pat’s significant expertise to our Board is very timely. We look forward to his guidance as we advance ATI-2173 in clinical development.”

Mr. Higgins has more than 35 years of biopharmaceutical executive experience of which the last 25 were with companies focused on infectious diseases including HBV and HCV for liver disease. His most recent position was as chief operating officer for Arbutus Biopharma, which is focused on developing a cure for HBV. In a prior role, he was a co-founder and chief executive officer of OnCore Biopharma, which he took public by merging with Tekmira Pharmaceuticals to form Arbutus. Before co-founding OnCore, he served as executive vice president, Commercial, for Pharmasset, which developed sofosbuvir, an FDA-approved therapy for HCV. Mr. Higgins was responsible for developing and executing the commercial strategy for sofosbuvir before the Company was acquired by Gilead Sciences in 2012 for $11 billion. Prior to Pharmasset, he led the infectious disease portfolio, including Pegasys^® for hepatitis infections, for Hoffman-LaRoche and spent 13 years at Schering Plough in various roles. Mr. Higgins is currently a director on the Board of Saronic Biotechnology. He earned is B.A. at Villanova University and his M.B.A. at Seton Hall University.

“I have spent much of my career in the pharmaceutical industry working for companies seeking treatments and cures for chronic hepatitis infections,” said Mr. Higgins. “Antios is focused on developing a functional cure for HBV, a public health objective that has yet to be achieved. I am looking forward to working with the Antios team to make this dream a reality.”

About ATI-2173
ATI-2173 is a novel, orally-administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) molecule designed to deliver the 5’-monophosphate of clevudine to the liver. This L-nucleoside’s active 5’-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor that distorts the active site of HBV polymerase resulting in potent HBV antiviral activity and extended off-treatment suppression of HBV DNA. ATI-2173 targets the liver, delivering high levels of the unique 5’- triphosphate while limiting systemic exposure to the parent L-nucleoside. ATI-2173 has the potential to become an integral part of a curative combination regimen for chronic hepatitis B.

About Antios Therapeutics Inc.
Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Antios is currently developing ATI-2173, aiming to provide chronic hepatitis B infected patients with a curative combination regimen.

VANCOUVER, BC, Feb. 10, 2021 /PRNewswire/ — Notch Therapeutics, Inc., a biotechnology company developing renewable, induced pluripotent stem cell (iPSC)-derived cell therapies for cancer, announced today the closing of an oversubscribed U.S. $85 million Series A financing. The financing was led by an exclusively healthcare-focused investment fund, with participation by existing investors Allogene Therapeutics, Inc. (NASDAQ: ALLO), Lumira Ventures, and CCRM Enterprises Holdings Ltd., an affiliate of Centre for Commercialization of Regenerative Medicine (CCRM); along with new investors EcoR1 Capital, a undisclosed leading global investment firm, Casdin Capital, Samsara BioCapital, and Amplitude Ventures. Proceeds from the financing will support the continuing development of Notch’s portfolio of iPSC-derived T cell therapeutic product candidates and clinical readiness of the company’s proprietary Engineered Thymic Niche (ETN) platform. The financing will also enable Notch to expand its team to support the company’s future growth, including establishing operations in Seattle, in addition to the company’s existing operations in Vancouver and Toronto.

“We are gratified to have the confidence of this exceptional group of investors and have them share in our vision that our platform can be game-changing for cell therapies by easing cell manufacturing and broadening their clinical and commercial potential,” said David Main, President and Chief Executive Officer of Notch. “The level of interest in this financing round enabled us to far exceed our original capital-raising goals. With this support, Notch is well positioned to support our partners and advance development of our initial cell therapy products for patients with cancer.”

Notch is applying its scalable Engineered Thymic Niche (ETN) technology platform to develop homogeneous and universally compatible, stem cell-derived cell therapies. To date, Notch has assembled a world-class scientific team and built a fully integrated, tightly controlled platform for generating and editing immune cells from clonal stem cells to enable development of a broad range of T cell therapeutics. Notch has an existing partnership with Allogene Therapeutics to apply Notch’s proprietary ETN platform to develop CAR-targeted, iPSC-derived, off-the-shelf T cell or natural killer (NK) cell therapies for hematologic cancer indications.

“We have great confidence in Notch’s high-caliber management team and the rigorous science underlying its research programs,” said David Chang, M.D., Ph.D., President, Chief Executive Officer, and Co-Founder of Allogene and a member of the Notch Board of Directors. “We are impressed by the company’s innovation and accomplishments and pleased to continue our support of Notch as the company advances the development of a new generation of cell therapies for cancer and other immune disorders.”

About Notch Therapeutics (www.notchtx.com)
Notch is developing a pipeline of cellular immunotherapies originating from pluripotent stem cells that are specifically engineered to address the underlying biology of complex disease systems. The company has unlocked the ability for large-quantity production of T cells and other cells from any source of stem cells to bring best-in-class cell therapies for cancer and other immune disorders to thousands of patients. The core of the Notch platform is the Engineered Thymic Niche (ETN), which enables precision control of cell fate during the differentiation and expansion of stem cells in suspension bioreactors without the need for feeder cells or serum. The ETN has the potential to generate immunotherapies with decreased variability, increased potency, and engineered improvements. The technology was invented in the laboratories of Juan-Carlos Zúñiga-Pflücker, Ph.D. at Sunnybrook Research Institute and Peter Zandstra, Ph.D., FRSC at the University of Toronto. Notch was founded by these two institutions, in conjunction with MaRS Innovation (now Toronto Innovation Acceleration Partners) and the Centre for Commercialization of Regenerative Medicine (CCRM), which initially incubated the company.

Contact:
Mary Moynihan
M2Friend Biocommunications
802-951-9600
mary@m2friend.com

SOURCE Notch Therapeutics

TORONTO, ON / ACCESSWIRE / February 2, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has secured a commitment of up to C$14 million (US$ 11 million) from the Government of Canada to complete the Phase 2 portion of a Phase 2/Phase 3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients. The funding will also help fund certain pre-clinical research intended to broaden the utility of the company’s experimental therapy, including treatments for other respiratory pathogens. The funds were awarded under the federal government’s Strategic Innovation Fund following a multi-disciplinary review of Edesa’s drug technology and plans.

“The award of this competitive funding is an important validation of the therapeutic potential of EB05 and the scientific rationale behind our efforts. The funds will be targeted toward rapidly getting EB05 into the hands of physicians on the front line of this health crisis,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “By targeting the body’s underlying response, our experimental drug offers a potential solution that could be effective despite variations in the virus.”

The Honorable François-Philippe Champagne, Minister of Innovation, Science and Industry, said that Strategic Innovation Fund (SIF) funding announced today is part of the government’s plan to support the development of novel medical countermeasures for COVID-19 patients. “As countries around the world begin to distribute and administer COVID-19 vaccines to their populations, we cannot lose sight of the importance of developing treatments to limit the long-term impacts of the virus on Canadians. Today’s contribution will support Edesa as they take their promising treatment through clinical trials and subsequent approvals. Once approved, this therapy has the potential to be an important tool in treating and preventing lung injuries caused by COVID-19. As the government continues to protect and support Canadians through this pandemic, it must also lay the foundation for a better-prepared, healthier and more prosperous future,” he said.

EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients. Specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling – an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of ICU patients and intubation/ventilation procedures, and ultimately saving lives.

The company intends to use the SIF funding for Phase 2 study expenses. Edesa’s ongoing Phase 2/3 study is an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. Up to 316 patients will be enrolled in the first phase of the trial. Patients will be infused intravenously with a single dose of EB05 or placebo. Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study.

“We greatly appreciate the support of the Government of Canada and the effort of the staff of the Innovation, Science and Economic Development (ISED) department in leading the technical review of our application,” said Michael Brooks, PhD, President of Edesa Biotech. “We look forward to working with the government on the next steps in the program and continuing to build on Canada’s emergency preparedness capabilities.”

In addition to the ongoing clinical study, the SIF funding will also be used to support a research project at a Canadian university. Among other objectives, the in vitro pre-clinical study will examine the potential therapeutic utility of EB05 against a panel of pathogens, including coronavirus variants and influenza strains.

Hospitals and physicians interested in participating in the Phase 2/3 study of EB05 should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT04401475)

About ARDS

Acute Respiratory Distress Syndrome is the leading cause of death in COVID-19 patients. The U.S. Centers for Disease Control (CDC) reports that 20% to 42% of hospitalized COVID-19 patients develop ARDS, which increases to 67% to 85% for patients admitted to the ICU. Mortality among patients admitted to the ICU ranges from 39% to 72% depending on the study and characteristics of patient population, according to the CDC. ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that results in edema that deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to COVID-19, ARDS accounted for approximately 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. Edesa’s lead product candidate, EB01, is a novel non-steroidal anti-inflammatory molecule (sPLA2 inhibitor) for the treatment of chronic allergic contact dermatitis which has demonstrated statistically significant improvements in multiple clinical studies. The company is developing late-stage monoclonal antibodies that block certain immune signaling proteins, known as TLR4 and CXCL10. These molecules are associated with a broad range of diseases, including the inflammation associated infectious diseases. Due to the global health emergency, Edesa has prioritized the development of EB05 as a potential treatment for hospitalized COVID-19 patients. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s belief that EB05 could regulate the overactive immune response associated with ARDS, the company’s belief that EB05 could modulate the TLR4 signaling pathway for the benefit of patients, the company’s belief that EB05 could provide effective treatment for current and future variations of the SARS-CoV2 virus, and the company’s plans regarding its Phase 2/3 study and the use of SIF funding. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as COVID-19. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

Contact:

Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
investors@edesabiotech.com

 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNIS^TM (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). LUPKYNIS is the first FDA-approved oral therapy for LN. LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). LUPKYNIS is now available to patients in the United States (U.S.).

In pivotal trials, patients treated with LUPKYNIS in combination with standard-of-care (SoC) were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio (UPCR) twice as fast as patients on typical SoC alone. UPCR is a standard measurement used to monitor protein levels in the kidney. Early intervention and kidney response are linked to better long-term outcomes and prevent irreversible kidney damage. Patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically-active classes of LN studied.

“The LUPKYNIS approval marks a turning point for the lupus nephritis community – patients, caregivers, families, and healthcare professionals – all of whom we thank for their partnership in the development of this innovative novel treatment. We are thrilled to bring LUPKYNIS to the people impacted by this devastating condition,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals. “The approved label supports the efficacy and safety of LUPKYNIS as well as Aurinia’s proprietary and patented eGFR pharmacodynamic dosing protocol. We have worked tirelessly to put the correct team and infrastructure in place to ensure we are ready for swift commercial adoption of LUPKYNIS.”

“For years treating patients with lupus nephritis has been challenging. We have had a very limited number of therapeutic options, and these have been only modestly effective but highly toxic,” said Brad H. Rovin, M.D., Professor of Medicine and the Director of the Division of Nephrology, Ohio State University Wexler Medical Center, and AURORA clinical trial investigator. “The FDA approval of LUPKYNIS allows us to treat patients safely and more effectively with a rapid acting therapy which requires far less steroids, something our patients will appreciate.”

To assist LUPKYNIS patients and the healthcare provider (HCPs) who prescribe the treatment, Aurinia has developed and launched Aurinia Alliance™, a patient support program featuring dedicated nurse case managers who provide personalized educational resources and assistance in navigating insurance and Aurinia medication costs throughout each patient’s LUPKYNIS treatment journey. To learn more about Aurinia Alliance or LUPKYNIS, visit www.LUPKYNIS.com.

“People with lupus nephritis have desperately needed approved treatments to help them avoid irreversible kidney damage and the eventual need for kidney transplant,” said Stevan W. Gibson, President and CEO, Lupus Foundation of America. “The approval of a tailored therapy represents a significant step forward in treating lupus nephritis and is excellent news for the lupus community.”

“Despite strong efforts in research to find solutions for SLE and LN, options to-date have been limited. Once patients progress to LN, they face inevitable life-altering effects,” said Kenneth M. Farber, President and CEO, Lupus Research Alliance. “We have long supported Aurinia Pharmaceuticals and are encouraged by the U.S. FDA approval of voclosporin, a much-needed oral treatment option to address the challenges faced by people living with LN.”

“New treatments indicated specifically for lupus nephritis will contribute to our quest for health equity in kidney diseases,” commented National Kidney Foundation’s Chief Medical Officer Joseph Vassalotti, M.D. “Interventions that are effective to manage and potentially prevent irreversible kidney damage are exciting for people living with lupus nephritis and their clinicians in nephrology and rheumatology.”

“As a patient-led organization who understands all too well the urgent need for more efficacious treatments for people struggling to live with diseases of unmet need like lupus nephritis, we are thrilled with the approval of LUPKYNIS,” said Kathleen A. Arntsen President and CEO of Lupus and Allied Diseases Association. “There is now a new treatment for this debilitating and life-diminishing condition that is four times higher for people of African descent and Asians and two times higher for Hispanics/Latinos and Native Americans. At a time when our nation faces extreme challenges such as addressing and overcoming social inequities and health disparities, this is welcome and promising news, especially since both lupus nephritis and COVID-19 disproportionately impact communities of color.”

LUPKYNIS was approved by the FDA under Priority Review and was previously granted Fast Track designation from the Agency in 2016. To learn more visit www.auriniapharma.com.

Multimedia Components and Conference Call Information

Multimedia components are available with this press release (link here). Aurinia will host a conference call and webcast to discuss the approval of LUPKYNIS on Monday, January 25, 2021 at 8:30 a.m. ET. The webcast can be accessed on the investor section of the Aurinia website at www.auriniapharma.com. To participate in the teleconference, please dial +1-877-407-9170 (Toll-free U.S. & Canada).

Clinical Trial Overview of LUPKYNIS (voclosporin)

The approval of LUPKYNIS is based on data from Aurinia’s pioneering late-stage global clinical studies in LN – the pivotal AURORA Phase 3 study and the AURA-LV Phase 2 study. These studies together demonstrated the ability of LUPKYNIS treatment to significantly improve outcomes as reported up to 52 weeks, for patients on several parameters when added to the typical SoC, mycophenolate mofetil (MMF), and low dose steroids.

In both studies, a total of 533 patients with LN were randomized to receive either LUPKYNIS 23.7 mg or placebo twice daily used with SoC. All patients were dosed with concurrent MMF at a target dose 2 g/day. In both studies, initial treatment with intravenous (IV) methylprednisolone up to a cumulative dose of 1 g was administered on Days 1 and 2, and all patients received a subsequent taper of oral corticosteroids. The starting dose of oral prednisone was 20 mg/day for patients with a body weight of <45 kg and 25 mg/day for patients ≥45 kg. The dose of oral corticosteroid was tapered down to achieve a target dose of 2.5 mg/day by Week 16. The studies enrolled patients with LN of Class III or IV (alone or in combination with Class V) or pure Class V. Enrolled patients were required to have baseline eGFR >45 mL/min/1.73 m².

In the Phase 3 study, at one year, LUPKYNIS plus SoC was more than two times as effective at achieving a complete renal response than the SoC alone. Patients in the study taking LUPKYNIS also achieved a 50 percent reduction in UPCR twice as fast as SoC, and a higher portion of LUPKYNIS-treated patients achieved a complete renal response at 24 weeks compared to patients receiving SoC. The study results were achieved using a protocol-defined steroid taper. Patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically-active classes of LN studied.

The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

About Lupus Nephritis

Lupus nephritis (LN) is a serious progression of SLE, a chronic, complex and autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

About Aurinia

Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company has introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). The Company’s head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATIONS

LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

CONTRAINDICATIONS: LUPKYNIS is contraindicated inpatients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.

WARNINGS AND PRECAUTIONS

Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.

Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.

Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.

Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.

Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.

QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.

Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.

ADVERSE REACTIONS

The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

SPECIFIC POPULATIONS

Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.

Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m² unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.

Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.

Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.

Forward-Looking Statements

Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia’s estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; the proportion of Black and Asian individuals, and individuals with Hispanic ancestry, compared to Caucasian individuals, to develop LN; Aurinia enhancing access with a variety of patient services and healthcare engagement initiatives. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of the results from our clinical trials; the accuracy of reported data from third party studies and reports; that Aurinia’s intellectual property rights are valid and do not infringe the intellectual property rights of third parties. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following difficulties we may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; Aurinia may have to pay unanticipated expenses; Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion; unknown impact and difficulties imposed by the COVID-19 pandemic on our business operations including nonclinical, clinical, regulatory and commercial activities; the results from our clinical studies and from third party studies and reports may not be accurate; and our assets or business activities may be subject to disputes that may result in litigation or other legal claims. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

All forward-looking information contained in this presentation is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar

View source version on businesswire.com: https://www.businesswire.com/news/home/20210122005501/en/

Investors:
Glenn Schulman, PharmD, MPH
Investor Relations & Corporate Communications, Aurinia
gschulman@auriniapharma.com

Corporate:
Dana Lynch
Corporate Communications, Aurinia
dlynch@auriniapharma.com

Media:
Stefan Riley
Ten Bridge Communications
stefan@tenbridgecommunications.com

Source: Aurinia Pharmaceuticals Inc.

Released January 22, 2021

Hillrom (NYSE: HRC) today announced it has reached a definitive agreement to acquire Bardy Diagnostics, Inc. (BardyDx), an innovator in digital health and a leading provider of ambulatory cardiac monitoring technologies. Under the terms of the agreement, Hillrom will purchase BardyDx for a cash consideration of $375 million and future potential payments based on the achievement of certain commercial milestones. Hillrom is also acquiring net operating losses valued at more than $20 million that are expected to result in future tax benefits.

“This acquisition provides Hillrom with a highly strategic and differentiated diagnostic cardiology platform aligned with our vision of Advancing Connected Care™, as well as an attractive recurring, high-growth revenue stream and gross margin profile,” said Hillrom President and CEO John Groetelaars. “BardyDx brings a talented team with significant commercial, clinical and scientific expertise, and dedicated independent diagnostic testing facilities. We look forward to welcoming the 230 employees who will join us in our mission of enhancing outcomes for patients and their caregivers.”

The acquisition of BardyDx complements Hillrom’s current cardiology portfolio of cardiac stress exercise, Holter and resting electrocardiography (ECG) devices. BardyDx, with annualized revenue of approximately $30 million, provides a differentiated, wearable bio-sensing technology, the Carnation Ambulatory Monitor (or CAM™ patch), that is engineered for patient-comfort, superior P-wave clarity, exceptional diagnostic yield and superior clinical accuracy.

“We set out to elevate ECG monitoring through an entirely new approach to signal processing, ECG reader training and report analysis tools and format, which allow for precise diagnoses of both common and abstruse arrhythmias,” said Gust H. Bardy, M.D., electrophysiologist, founder and chief medical officer of Bardy Diagnostics. “Our team coupled advanced diagnostics with comfort and ease-of-use for the patient, and simple implementation for clinicians. By joining Hillrom, we will broaden our footprint globally with the goal of providing greater patient value and more confident physician diagnoses.” 

The CAM patch is designed to promote patient compliance, streamline clinical workflow, and yield clinically actionable data in a unique and proprietary CAM™ report that enables physicians to identify specific arrhythmias to aid clinical decision-making. The device employs a novel circuit design and uses advanced compression algorithms to process the signal, ensuring P-wave recording and accuracy, a significant attribute for cardiologists and electrophysiologists.

Hillrom’s existing global brand, channel and presence in acute and primary care settings, and capabilities around market access, payor contracting, data security and EMR integration, are expected to drive accelerated adoption of the CAM patch and BardyDx’s related suite of ECG analysis services and tools.

Hillrom intends to finance the acquisition through a combination of cash on hand and borrowings under existing credit facilities, and expects to close the transaction in the fiscal second quarter of 2021, subject to customary closing conditions. Hillrom expects the transaction to be dilutive to fiscal 2021 adjusted earnings by approximately $0.10 per diluted share and does not expect the transaction to have an impact on its previously issued fiscal 2021 financial guidance. The transaction is expected to be dilutive in the first twelve months, increasingly accretive thereafter, and generate 10% return on invested capital by year five. The company will provide additional information on its fiscal first quarter 2021 earnings conference call.

About Bardy Diagnostics, Inc.
Bardy Diagnostics was founded in 2013 by electrophysiologist Gust H. Bardy, M.D. The company’s mission is to improve clinical management and outcomes for patients and their physicians by deploying innovative P-wave-centric ECG detection into patient-friendly technologies that result in greater patient compliance and more confident physician diagnoses. After years of meticulous R&D, BardyDx developed the first continuous-wear, wire-free ambulatory patch monitor that provides unparalleled signal clarity with a focus on the P-wave: the Carnation Ambulatory Monitor, or CAM™ patch. Learn more at BardyDx.com.

About Hillrom
Hillrom is a global medical technology leader whose 10,000 employees have a single purpose: enhancing outcomes for patients and their caregivers by advancing connected care. Around the world, our innovations touch over 7 million patients each day. They help enable earlier diagnosis and treatment, optimize surgical efficiency and accelerate patient recovery while simplifying clinical communication and shifting care closer to home. We make these outcomes possible through digital and connected care solutions and collaboration tools, including smart bed systems, patient monitoring and diagnostic technologies, respiratory health devices, advanced equipment for the surgical space and more, delivering actionable, real-time insights at the point of care. Learn more at hillrom.com.

Cyrano Therapeutics, a clinical stage regenerative medicine company developing a novel intranasal therapy for smell and flavor restoration, has raised $12.8 million in a Series A financing led by Remiges Ventures and Lumira Ventures, with the participation of additional investors. The funds will be used to complete a Phase 2 clinical trial of the company’s lead product, CYR-064, in the U.S. and Europe.  As part of the financing, Taka Koda of Remiges Ventures and Gerry Brunk of Lumira Ventures have joined the company’s board of directors.

The chronic loss of smell and flavor is a condition affecting at least 5% of the population in the U.S. with a similar incidence in Europe and Asia. Influenza, allergic rhinitis and traumatic brain injury are commonly known causes of chronic smell and flavor loss. In the neurodegenerative disease sector, it is also known that 95 percent of Parkinson’s patients experience smell and flavor loss, often as the first symptom of the disease. 

Over the past year, clinicians now recognize that over 90% of COVID-19 patients experience at least some smell loss or smell distortion (known as anosmia, hyposmia or parosmia), with over half of them experiencing severe to complete loss of smell and flavor. Although many patients recover, an indeterminate number may have a chronic dysfunction in need of long-term treatment. The company expects to include COVID-19 patients in its clinical trial, along with patients whose loss of smell resulted from other viral infections.

Cyrano Therapeutics was founded after Chief Executive Officer Rick Geoffrion experienced a long-term loss of smell and flavor due to the flu several years ago. Partnering with Robert Henkin, PhD, Director of The Taste and Smell Clinic in Washington D.C., they co-founded Cyrano Therapeutics to bring a safe and effective treatment to patients.

“When losing all sense of smell and flavor, you realize the magnitude of the issue and how much these senses are intertwined with general social interaction, appetite, libido and memory.  These are the building blocks of everyday life and integral to one’s physical and mental quality of life. Importantly, our sense of smell also alerts us to threats including gas leaks, smoke and spoiled food. Together with Dr. Henkin, we are on a mission to take this therapy through rigorous trials and provide full access for the millions who need it,” says Geoffrion.

About Cyrano Therapeutics

Cyrano Therapeutics is a private, venture-backed clinical stage regenerative medicine company developing a novel therapy to restore smell and flavor function. The chronic loss of smell and flavor is a condition affecting at least 5% of the U.S. population with a similar incidence in Europe and Asia. Influenza, allergic rhinitis and traumatic brain injury are commonly known causes of chronic smell and flavor loss. The condition is now recognized as a widely prevalent long-term condition suffered by many patients who have recovered from COVID-19.   www.cyranotherapeutics.com

SOURCE:Cyrano Therapeutics

enGene Inc., A biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to enGene for EG-70, the company’s lead investigational non-viral gene therapy for the treatment of patients with Bacille Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).  

The Fast Track program is intended to facilitate the development and expedite the review of therapies that treat serious conditions and fill an unmet medical need. Therapeutic programs that receive Fast Track Designation can benefit from more frequent communication with the FDA, eligibility for Priority Review and Accelerated Approval, and potentially for Rolling Review of the marketing application.

“Fast Track Designation underscores the urgent need for new and effective treatments for BCG-unresponsive NMIBC patients,” said Jason Hanson, Chief Executive Officer at enGene. “We are pleased with the FDA’s recognition of our EG-70 program with this designation and we look forward to working closely with the FDA throughout the clinical development process to bring this innovative treatment to patients as quickly as possible.”

About enGene Inc.
enGene Inc. is a biotechnology company developing a proprietary non-viral gene therapy platform for localized delivery of nucleic acid payloads to mucosal tissues. The dually derived chitosan (DDX) platform has a high-degree of payload flexibility including DNA and various forms of RNA with broad tissue and disease applications. In addition to developing EG-70 for BCG-unresponsive NMIBC, enGene is developing unique genetic medicines for respiratory indications and the company is evolving its technology to enable applications in multiple mucosal tissues with areas of high unmet medical need. http://www.engene.com 

Former CEO and Antios co-founder, Abel De La Rosa, Ph.D., appointed Chairman of the Board of Directors

Mayes to lead continued development of ATI-2173 as a potential backbone of a curative regimen for Hepatitis B (“HBV”)

ATLANTA, Dec. 01, 2020 (GLOBE NEWSWIRE) — Antios Therapeutics, Inc. (“Antios”) today announced the appointment of Gregory T. Mayes as Chief Executive Officer and Director. Mr. Mayes succeeds Abel De La Rosa, Ph.D., who co-founded Antios in 2018 and has served as CEO and Director since its inception. Dr. De La Rosa, who is retiring from his full-time role, will remain with Antios as an advisor and will assume the role of Chairman of its Board of Directors.

“On behalf of our Board of Directors, we are thrilled to have Greg join Antios as our new CEO and lead the company to its next stage of development,” said Dr. De La Rosa. “Greg is an accomplished biopharma executive with a sterling track record of success at both building startups and managing established organizations. He has led companies through early- and late-stage clinical development programs as well as commercial launches. Our lead clinical candidate, ATI-2173, is approaching an important inflection point in its development with the upcoming readout from our Phase 1 study in both healthy volunteers and HBV-infected subjects and the commencement of our Phase 2 program in early 2021.”

“Having led Antios from preclinical development to the well capitalized, clinical stage biopharmaceutical company it is today, I feel this is the opportune time for a leadership change. I truly believe that we are well positioned for continued success and I am confident that Antios will flourish under Greg’s leadership. As a co-inventor of ATI-2173, I am deeply committed to its success, and look forward to remaining actively involved, both as Chairman of the Board and in my new role as Senior Scientific and Strategic Advisor.”

Mr. Mayes joins Antios following the acquisition of Engage Therapeutics (“Engage”) by UCB in June 2020. He co-founded Engage and served as CEO from 2017 until its acquisition, which came following positive data from a large, randomized Phase 2 clinical trial of its lead product candidate in development for a new product category called REST (Rapid Epileptic Seizure Termination). Prior to founding Engage, he was Chief Operating Officer and a Board member at Advaxis Immunotherapies, where he developed the Phase 3 registration strategy and clinical development plan for its lead product candidate and established multiple major pharma partnerships. Previously, he was President, General Counsel and Board member at Unigene Laboratories, where he led out-licensing efforts for a novel oral peptide delivery platform. He was also Vice President, General Counsel, and Chief Compliance Officer at ImClone Systems (“ImClone”), where he was actively involved in the clinical development and commercial launch plans for ERBITUX® (cetuximab) and was instrumental in ImClone’s sale to Eli Lilly in 2008. He began his career as Senior Counsel at AstraZeneca Pharmaceuticals LP, where he provided legal services related to the development and commercialization of multiple oncology products. He earned his J.D. degree from Temple University School of Law, where he was Articles Editor on the Temple Law Review and holds a bachelor’s degree from Syracuse University. Mayes currently sits on the Boards of AVEO Oncology and Receptor Life Sciences.

“I am extremely grateful to the Board for this opportunity and excited to build upon the solid foundation that Abel and his team have established over the last several years,” said Mr. Mayes. “In ATI-2173, we have a promising clinical candidate and compelling scientific rationale to position it as the potential backbone of a functional cure regimen for HBV, a significant unmet need. I look forward to leading its continued clinical development and to the many opportunities that lie ahead for Antios.”

About ATI-2173
ATI-2173 is a novel liver-targeted molecule designed to deliver the 5’-monophosphate of clevudine. This L-nucleoside’s active 5’-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor. By selectively delivering the 5’-monophosphate to the liver, while retaining the unique anti-HBV activity of the active 5’- triphosphate, ATI-2173 could become an integral part of a curative combination regimen for chronic hepatitis B.

About Antios Therapeutics Inc.
Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Antios is currently developing ATI-2173, aiming to provide chronic hepatitis B infected patients with a curative combination regimen.

CONTACTS

Investors:
Idean Marvasty
ir@antiostherapeutics.com

Media:
Antios Public Relations
pr@antiostherapeutics.com

TEWKSBURY, Mass., Nov. 17, 2020 /PRNewswire/ — Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure (HF), today announced completion of randomization in its REDUCE LAP-HF II global, pivotal trial. The trial is evaluating the Corvia^® Atrial Shunt (IASD^®) – a novel, transcatheter implant – to reduce elevated left atrial pressures (LAP), the primary cause of HF symptoms, in heart failure patients with preserved ejection fraction (HFpEF) or mid-range ejection fraction (HFmrEF). The company also announced authorization by the Food and Drug Administration (FDA) to continue evaluation of the Corvia Atrial Shunt under a Continued Access Protocol (CAP) while its pre-market approval (PMA) application is under review. PMA submission is planned for late 2021.

REDUCE LAP-HF II is the world’s first large, prospective, multicenter, randomized, sham-controlled trial to evaluate interatrial shunting. The study randomized 626 patients at 109 sites across 15 countries, with the aim to improve quality of life, reduce HF symptoms and decrease HF-related hospitalizations. Primary outcome measures will be evaluated after the last randomized patient completes 12-month follow-up. Sanjiv Shah, MD from Northwestern University Feinberg School of Medicine in Chicago, Illinois, and Martin Leon, MD from the Columbia University Irving Medical Center in New York, NY serve as lead principal investigators.

“The outcome of the landmark REDUCE LAP-HF II trial has the potential to revolutionize how we treat these heart failure patients, which is the greatest unmet need in cardiology today,” stated Sanjiv Shah, MD. “Treating this population is challenging, and often frustrating, because standard treatments for heart failure don’t work well. Data from this study evaluating the efficacy of the Corvia Atrial Shunt will provide valuable information regarding this novel therapy in this underserved patient population.” Martin Leon, MD added, “In light of the increasing incidence of heart failure, innovative treatment options are of critical importance. We are pleased with the study execution and enrollment pace of this trial, and are eagerly awaiting the results, which have the potential to change the treatment paradigm for heart failure.”

“Randomizing the last pivotal trial patients is a significant milestone for Corvia and brings us one step closer to providing this innovative technology to patients in the US,” said George Fazio, President and CEO of Corvia Medical. “REDUCE LAP-HF II is one of the largest randomized heart failure device trials ever undertaken and demonstrates our commitment to building a strong body of clinical evidence showing how atrial shunting advances care for patients suffering with the debilitating symptoms of heart failure.”

Corvia also announced FDA authorization to continue patient enrollment under a CAP. The open label REDUCE LAP-HF IV study will enroll patients at existing pivotal trial centers. “We are pleased to have the opportunity to continue to offer this breakthrough therapy to heart failure patients,” said Jan Komtebedde, Senior Vice President and Chief Medical Officer at Corvia Medical. “In collaboration with our advisors and investigators, we are committed to generating unbiased evidence to support this new therapeutic class of atrial shunting for heart failure. This study provides an opportunity to generate additional safety and efficacy evidence to support future therapy adoption.”

About Heart Failure
Heart failure (HF) is a chronic condition that affects approximately 26 million people worldwide.By 2030, that number will increase by almost 50%, to nearly 38 million people. More than half of all HF patients have HFpEF/HFmrEF, and that number is increasing, driven by population aging and other risk factors. In patients with HFpEF/HFmrEF, the proportion of blood pumped out of the heart is normal or relatively normal, but because the muscles of the left atrium and ventricle are stiff, the heart cannot relax and fill properly, causing an increase in pressures in the left heart chambers and the lungs. HFpEF/HFmrEF remains one of the most significant unmet needs in cardiovascular medicine. While there have been significant advances in treatment for heart failure with reduced ejection fraction (HFrEF), there currently are no effective treatments for HFpEF/HFmrEF. 

About the Corvia Atrial Shunt (IASD^®)
The Corvia Atrial Shunt is a novel, transcatheter implant for patients suffering from symptomatic heart failure (HF) and the first therapeutic device designed to directly address elevated left atrial pressure (LAP), the primary contributor of HF symptoms. The device (about the size of a dime) is implanted by an interventional cardiologist or electrophysiologist during a minimally invasive, outpatient procedure. After a small opening is created in the atrial septum, the Corvia Atrial Shunt is deployed, forming a passage between the left and right atria that enables the left atrium to decompress at rest and during physical activity, with the aim of lowering LAP and pressure in the lungs. By facilitating continuous and dynamic decompression of the left atrium, the Corvia Atrial Shunt aims to improve HF symptoms and quality of life, decrease HF hospitalizations, and reduce the overall cost of managing HF patients. The Corvia Atrial Shunt is the most clinically studied interatrial shunt for the reduction of LAP in symptomatic HF patients. It has been implanted in more than 400 patients worldwide and reviewed in over 20 publications. For more information, visit http://treatmyheartfailure.com. The Corvia Atrial Shunt is an investigational device and is not available for commercial distribution in the United States. The device is available for sale in the European Union.

About Corvia Medical, Inc.
Corvia Medical, Inc. is revolutionizing the treatment of heart failure through novel transcatheter cardiovascular devices. Founded in 2009 and headquartered in Tewksbury, MA, Corvia Medical is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim their lives. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences and an undisclosed strategic investor.

For more information, visit http://corviamedical.com/.

MEDIA CONTACT:
Lisa Ensz
Vice President, Marketing
Corvia Medical, Inc.
+1 978-654-6120
lensz@corviamedical.com

SOURCE Corvia Medical, Inc.Back

OTTAWA, ON, Nov. 10, 2020 /CNW/ – The world is shining the spotlight on science now more than ever as we face the challenges of the COVID-19 pandemic. As Canadian science and engineering researchers continue to lead on the world stage, the Government of Canada celebrates the country’s research excellence by honoring some of its best and brightest.

Today, Her Excellency the Right Honourable Julie Payette, Governor General of Canada, the Honourable Navdeep Bains, Minister of Innovation, Science and Industry, and Professor Alejandro Adem, President of the Natural Sciences and Engineering Research Council of Canada (NSERC) are pleased to announce this year’s recipients of NSERC Prizes. Twenty-six of Canada’s world-leading scientists and engineers, and 13 of their industry partners received NSERC prizes recognizing their contributions in a range of research fields. Topics explored include advancements to our understanding of the effects of climate change on biodiversity in urban, natural and ocean environments, the impact of aerosols on the Arctic, the development of sustainable pesticides, and innovations in quantum computing technology.

Dr. Molly Shoichet is this year’s recipient of Canada’s most prestigious science prize, the Gerhard Herzberg Canada Gold Medal for Science and Engineering, worth up to $1 million. Dr. Shoichet’s breakthrough invention of hydrogels enabled researchers to grow human cells in three-dimensional environments, and has since led to game-changing applications in the areas of tissue engineering, regenerative medicine and pharmaceutical testing. Dr. Shoichet’s contributions have fundamentally advanced biomedical engineering research and placed the next generation of medical treatments within our grasp.

Dr. Karen Maxwell is receiving this year’s John C. Polanyi Award in recognition of her ground-breaking discovery and ongoing contributions to the field of biochemistry. Dr. Maxwell and her team discovered that the soil-dwelling bacteria Streptomyces produces molecules that stop viruses in their tracks and prevent fast replication, a breakthrough that opens up a new method to screen for drugs that could be useful for the treatment of human cancers and viral infections.

NSERC celebrates research excellence with a wide range of prizes. Individual awards focus on accomplishments that range from innovative discoveries by young researchers to lifetime achievement and influence. 

Quotes

“Our government is steadfastly committed to science and research, and is proud to honor today’s recipients for their outstanding achievements in their fields. These researchers exemplify Canada’s culture of curiosity and innovation, and are making the breakthroughs that have the power to improve the lives of all Canadians from better understanding the effects of climate change to making medical advancements.”
–  The Honourable Navdeep Bains, Minister of Innovation, Science and Industry

“This year is about highlighting and celebrating how much science is playing an important role in our everyday lives. The prize winners showcase their excellence in science research with their breakthrough successes in diverse fields. Congratulations to all prize winners for their significant achievements.”
–  Professor Alejandro Adem, President of NSERC

“When I found out that I had won the Herzberg award, I was overwhelmed because it seems so unreachable. When you look at all the people who have won this award before me, they are people that I hold in such high esteem. To be among them, and to have my peers consider me to be among them, is so exciting and so thrilling.”
–  Dr. Molly Shoichet, Professor of Chemical Engineering & Applied Chemistry and Biomaterials & Biomedical Engineering, University of Toronto

Quick facts

• Honouring the memory of Canadian Nobel laureate Gerhard Herzberg, the NSERC Herzberg Gold Medal is the agency’s highest honour. It provides recipients with up to $1 million in discovery research funding over five years.
• Today’s ceremony celebrates the outstanding achievements of recipients who received five NSERC prizes totaling up to $3.95 million.
• NSERC-funded researchers are honoured every year for achievements that showcase the high caliber of talent and the innovative research taking place in Canadian universities and colleges.

Associated Links

Full list of NSERC prizes, this year’s winners and their profiles

NSERC invests over $1.2 billion each year in natural sciences and engineering research in Canada. Our investments deliver discoveries—valuable world firsts in knowledge claimed by a brain trust of over 11,000 professors. Our investments enable partnerships and collaborations that connect the makers and users of discoveries. Research partnerships established by NSERC help inform research and development and solve scale-up challenges.

NSERC also provides scholarships and hands-on training experience for more than 30,000 post-secondary students and post-doctoral fellows. These young researchers will be the next generation of science and engineering leaders in Canada.

SOURCE NSERC

For further information: John Power, Press Secretary, Office of the Minister of Innovation, Science and Industry, 343-550-1456, john.power@canada.ca; Media Relations, Innovation, Science and Economic Development Canada, 343-291-1777, ic.mediarelations-mediasrelations.ic@canada.ca; Christine Seguin, Media and Public Affairs Officer, Natural Sciences and Engineering Research Council of Canada, media@nserc-crsng.gc.ca

Related Links

https://www.canada.ca

Prizes recognize exemplary achievements by some of the best and brightest researchers in the world

OTTAWA, ON, Nov. 10, 2020 /CNW/ – The world is shining the spotlight on science now more than ever as we face the challenges of the COVID-19 pandemic. As Canadian science and engineering researchers continue to lead on the world stage, the Government of Canada celebrates the country’s research excellence by honoring some of its best and brightest.

Today, Her Excellency the Right Honourable Julie Payette, Governor General of Canada, the Honourable Navdeep Bains, Minister of Innovation, Science and Industry, and Professor Alejandro Adem, President of the Natural Sciences and Engineering Research Council of Canada (NSERC) are pleased to announce this year’s recipients of NSERC Prizes. Twenty-six of Canada’s world-leading scientists and engineers, and 13 of their industry partners received NSERC prizes recognizing their contributions in a range of research fields. Topics explored include advancements to our understanding of the effects of climate change on biodiversity in urban, natural and ocean environments, the impact of aerosols on the Arctic, the development of sustainable pesticides, and innovations in quantum computing technology.

Dr. Molly Shoichet is this year’s recipient of Canada’s most prestigious science prize, the Gerhard Herzberg Canada Gold Medal for Science and Engineering, worth up to $1 million. Dr. Shoichet’s breakthrough invention of hydrogels enabled researchers to grow human cells in three-dimensional environments, and has since led to game-changing applications in the areas of tissue engineering, regenerative medicine and pharmaceutical testing. Dr. Shoichet’s contributions have fundamentally advanced biomedical engineering research and placed the next generation of medical treatments within our grasp.

Dr. Karen Maxwell is receiving this year’s John C. Polanyi Award in recognition of her ground-breaking discovery and ongoing contributions to the field of biochemistry. Dr. Maxwell and her team discovered that the soil-dwelling bacteria Streptomyces produces molecules that stop viruses in their tracks and prevent fast replication, a breakthrough that opens up a new method to screen for drugs that could be useful for the treatment of human cancers and viral infections.

NSERC celebrates research excellence with a wide range of prizes. Individual awards focus on accomplishments that range from innovative discoveries by young researchers to lifetime achievement and influence. 

Quotes

“Our government is steadfastly committed to science and research, and is proud to honor today’s recipients for their outstanding achievements in their fields. These researchers exemplify Canada’s culture of curiosity and innovation, and are making the breakthroughs that have the power to improve the lives of all Canadians from better understanding the effects of climate change to making medical advancements.”
–  The Honourable Navdeep Bains, Minister of Innovation, Science and Industry

“This year is about highlighting and celebrating how much science is playing an important role in our everyday lives. The prize winners showcase their excellence in science research with their breakthrough successes in diverse fields. Congratulations to all prize winners for their significant achievements.”
–  Professor Alejandro Adem, President of NSERC

“When I found out that I had won the Herzberg award, I was overwhelmed because it seems so unreachable. When you look at all the people who have won this award before me, they are people that I hold in such high esteem. To be among them, and to have my peers consider me to be among them, is so exciting and so thrilling.”
–  Dr. Molly Shoichet, Professor of Chemical Engineering & Applied Chemistry and Biomaterials & Biomedical Engineering, University of Toronto

Quick facts

• Honouring the memory of Canadian Nobel laureate Gerhard Herzberg, the NSERC Herzberg Gold Medal is the agency’s highest honour. It provides recipients with up to $1 million in discovery research funding over five years.
• Today’s ceremony celebrates the outstanding achievements of recipients who received five NSERC prizes totaling up to $3.95 million.
• NSERC-funded researchers are honoured every year for achievements that showcase the high caliber of talent and the innovative research taking place in Canadian universities and colleges.

Associated Links

Full list of NSERC prizes, this year’s winners and their profiles

NSERC invests over $1.2 billion each year in natural sciences and engineering research in Canada. Our investments deliver discoveries—valuable world firsts in knowledge claimed by a brain trust of over 11,000 professors. Our investments enable partnerships and collaborations that connect the makers and users of discoveries. Research partnerships established by NSERC help inform research and development and solve scale-up challenges.

NSERC also provides scholarships and hands-on training experience for more than 30,000 post-secondary students and post-doctoral fellows. These young researchers will be the next generation of science and engineering leaders in Canada.

SOURCE NSERC

For further information: John Power, Press Secretary, Office of the Minister of Innovation, Science and Industry, 343-550-1456, john.power@canada.ca; Media Relations, Innovation, Science and Economic Development Canada, 343-291-1777, ic.mediarelations-mediasrelations.ic@canada.ca; Christine Seguin, Media and Public Affairs Officer, Natural Sciences and Engineering Research Council of Canada, media@nserc-crsng.gc.ca

Related Links

https://www.canada.ca