G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced results from an immunologic analysis of Phase 2 study data showing that trilaciclib enhances both CD4 and CD8 T cell function in certain patients with metastatic triple negative breast cancer (mTNBC) when administered prior to chemotherapy. Patients receiving placebo prior to chemotherapy did not demonstrate enhanced T cell function. Results of the immunologic analysis are being presented in a poster session at the 36^th Annual Meeting of The Society for Immunotherapy of Cancer (SITC), Nov. 10-14, 2021. The poster is available in the scientific publications section of the G1’s website.

“The Phase 2 immunologic data analysis suggests that administering trilaciclib prior to chemotherapy may enhance antitumor efficacy by modulating the composition and response of immune cell subsets,” said John Yi, PhD, Director of Translational Medicine at G1 Therapeutics.

In the exploratory analysis, researchers sought to investigate the immune mechanisms underlying the improved rate of overall survival shown in the 2020 Phase 2 trial of TNBC patients receiving trilaciclib in combination with gemcitabine/carboplatin (GCb) compared with GCb alone. The researchers evaluated tumor samples and peripheral blood samples from patients at baseline and after trilaciclib/GCb administration or after placebo/GCb administration to identify differential gene expression and changes in immune function between the two groups. Further, they measured qualitative and quantitative differences between patients who did respond or did not respond to trilaciclib plus GCb. Response to treatment was defined as partial or complete response, while nonresponse was defined as stable or progressive disease.

Among the findings in the poster titled, “Immune Profiling to Investigate Improved Survival in Patients with Metastatic Triple-Negative Breast Cancer Receiving Trilaciclib Prior to Chemotherapy”:

• Patients who received trilaciclib prior to GCb showed increased T cell function as measured by greater production of inflammatory cytokines
• Patients who received trilaciclib had fewer immune suppressing cells known as myeloid-derived suppressor cells (MDSCs) than patients who received GCb alone, whether they were responders or non-responders to treatment
• Non-responders to trilaciclib/GCb had a reduction in circulating CD4 and CD8 T cells and a decreased production of inflammatory cytokines

“It is critical that we fully understand the underlying immune mechanisms that contributed to the overall survival improvement that was seen in the Phase 2 mTNBC trials, and to identify biomarkers that will clearly distinguish between trilaciclib responders and non-responders,” said Dr. Yi. “We are further investigating the impact of trilaciclib on changes to the tumor-infiltrating immune response in our Phase 3 PRESERVE 2 trial in patients with mTNBC and in a planned mechanism-of-action trial in the neoadjuvant TNBC setting.”

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% to 20% of such diagnosed breast cancers. TNBC is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. Because TNBC cells lack key growth-signaling receptors, patients do not respond well to medications that block estrogen, progesterone, or HER2 receptors. Instead, treating TNBC 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 TNBC compared to other forms of breast cancer, and TNBC 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.

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. G1 has a deep clinical pipeline and is executing a tumor-agnostic development plan evaluating trilaciclib 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.

G1Therapeutics™ 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 that administering trilaciclib prior to chemotherapy may enhance antitumor efficacy by modulating the composition and response of immune cell subsets), and the therapeutic potential of trilaciclib, which has not been approved for and is not commercially available for any use described in this press release. Forward-looking statements 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 other than 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.

G1 Therapeutics Contact:

Will Roberts
Vice President, Investor Relations & Corporate Communications
919-907-1944
wroberts@g1therapeutics.com

Rebecca Levine
Director, Corporate Communications and Public Relations
(919) 667-8711
rlevine@g1therapeutics.com  

Cyrano Therapeutics, a clinical stage regenerative medicine company developing a novel intranasal therapy to restore smell and flavor function, today announced that it has appointed biopharmaceutical industry veteran John Kollins to its board of directors. Kollins is currently President and Chief Executive Officer of Satsuma Pharmaceuticals, Inc.  (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine currently in Phase 3 trials.

“We are excited to welcome John to our board of directors,” stated Rick Geoffrion, Chief Executive Officer of Cyrano. “With his extensive strategic, operational and financial expertise in clinical-stage biopharmaceutical companies, including those developing intranasal therapies and treatments for neurological disorders, he brings a valuable perspective to Cyrano as we advance our therapy for the restoration of the lost senses of smell and flavor through Phase 2 development.”

Kollins’ biopharmaceutical industry experience spans more than 30 years and includes serving as CEO, on board of directors, and in executive leadership positions concerning operations, strategy, business/corporate development and product development and in commercialization roles in discovery, clinical and commercial-stage public and private companies.

Prior to co-founding Satsuma in 2016, he served as Chief Business Officer and Senior Vice President at Transcept Pharmaceuticals, a publicly-traded, neuroscience-focused specialty pharmaceuticals company. He also served successively as Chief Business Officer, Chief Operating Officer and Chief Executive Officer and a member of the board of directors at OXiGENE, Inc., a publicly-traded oncology and ophthalmology company. Earlier he served in business/corporate development and product management roles of increasing responsibility at CovX, Renovis, Elan Pharmaceuticals / Athena Neurosciences and Immunex Corporation.  He received a B.S.E. degree from Duke University and an M.B.A. from the University of Virginia’s Darden School of Business

“I am very pleased to join the Cyrano Therapeutics board of directors,” commented Kollins, “and I look forward to working closely with the company’s board and management on their mission to address this important unmet patient need. Patients suffering long term smell and flavor loss are effectively without 2 of the 5 senses we have as human beings, and tragically COVID-19 has significantly increased the prevalence of this condition and the need for effective therapies.”

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. The company raised a $12.8M Series A financing in December 2020 led by Remiges Ventures and Lumira Ventures.  www.cyranotherapeutics.com

SOURCE Cyrano Therapeutics

Iterion Therapeutics, Inc., a venture-backed, clinical-stage biotechnology company developing novel cancer therapeutics, today announced the initiation of a Phase 1/2 clinical trial to investigate tegavivint as a potential treatment for pediatric cancers, including sarcomas, lymphomas and other solid tumors that are prevalent in pediatric populations. This Children’s Oncology Group Pediatric Early Phase Clinical Trials Network (COG PEP-CTN)-sponsored trial, led by Sarah Whittle, M.D. Assistant Professor, Department of Pediatrics, Section of Hematology-Oncology, Baylor College of Medicine and pediatric oncologist at Texas Children’s Cancer Center, started recruiting patients this month.

COG and PEP-CTN are National Cancer Institute (NCI)-supported clinical trials groups, comprising the world’s largest organization devoted exclusively to childhood and adolescent cancer research including early-phase trials. The PEP-CTN is dedicated to conducting early phase clinical trials in children with cancer, building upon the success of the Children’s Oncology Group (COG) Phase 1 & Pilot Consortium.

Tegavivint is a potent and selective first-in-class small molecule inhibitor of Transducin Beta-like Protein One (TBL1), a novel downstream target in the Wnt/beta-catenin signaling pathway.  Beta-catenin and TBL1 expression are associated with metastasis and poor prognosis in a broad range of tumor types that are predominantly found in pediatric populations. Tegavivint’s targeting of TBL1 prevents the TBL1/beta-catenin complex from forming and specifically inhibits beta-catenin’s oncogenic activity without disrupting key cell membrane functions that have been linked to toxicity common to other drugs in this pathway.

“We are very pleased to collaborate with COG-NCI to initiate this Phase 1/2 clinical trial of tegavivint as a potential targeted treatment for pediatric cancers,” said Rahul Aras, Ph.D., CEO of Iterion. “Research involving tegavivint suggests that it could be ideally suited to addressing a range of pediatric cancers based on its ability to inhibit TBL1 and, in turn, disrupt the oncogenic activity of beta-catenin.  This unique mechanism of action, combined with tegavivint’s demonstrated safety profile in desmoid tumor patients, formed the basis for COG PEP-CTN to initiate the Phase 1/2 trial as a first step in the potential development of tegavivint for both solid and hematologic pediatric tumors.”

The Phase 1/2 clinical trial (COG Study PEPN2011; ClinicalTrials.gov Identifier: NCT04851119) of tegavivint in pediatric cancers is fully sponsored by COG PEP-CTN, with support from Iterion, and will be conducted at their 21 consortium clinical centers comprising the leading pediatric cancer centers in the United States. 

“We welcome the opportunity to lead this clinical trial of tegavivint, which targets TBL1, a novel therapeutic target in the Wnt-signaling pathway that has been implicated in multiple pediatric cancers,” said Dr. Sarah Whittle, Principal Investigator for the study. “This trial gives us the ability to enrich our understanding of tegavivint’s utility in multiple cancer types that specifically impact children and for which few treatments exist other than chemotherapy.”

Each year more than 16,000 children in the US¹ and 400,000 worldwide² are diagnosed with cancer, making it the number one cause of death by illness in children³. Treatment options for children are limited and consist mostly of surgery, radiation and various chemotherapies.

Dr. Aras continued, “Cancer is a devastating disease, but particularly when it impacts children.  While current treatment options offer hope, they can be harsh on pediatric patients, leading to many unintended downstream consequences for survivors, such as heart and lung damage or secondary cancers including myelodysplastic syndrome, acute myeloid leukemia and solid tumors. The development of safer and potentially curative treaments that spare children from short-term and long-term treatment side effects remains a critical goal.  We believe tegavivint holds such promise.”

The Phase 1/2 study of tegavivint in pediatric cancer patients follows compelling clinical data establishing the drug’s safety and clinical activity in adults with progressive and nonresectable desmoid tumors. The Phase 1/2a desmoid study enrolled 24 patients who received tegavivint. The treatment was well-tolerated with no observed dose limiting toxicities with several patients having received treatment for more than a year.

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 small molecule that binds to TBL1 in the nucleus inhibiting nuclear beta-catenin signaling and oncogenic activity. 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 clinical trial in patients with relapsed or refractory acute myeloid leukemia (AML) and a Phase 1/2 trial in pediatric patients with sarcomas, lymphomas and other solid tumors, excluding central nervous system (CNS) tumors. Iterion is also pursuing a clinical program in non-small cell lung cancer (NSCLC), in which nuclear beta-catenin signaling has been shown to play a role.  Data from a Phase 1/2a clinical trial of tegavivint in patients with progressive desmoid tumors demonstrated safety and preliminary clinical efficacy. 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.

About The Children’s Oncology Group (COG) and Pediatric Early Phase Clinical Trials Network (PEP-CTN)
COG (childrensoncologygroup.org), a member of the NCI National Clinical Trials Network (NCTN), is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. COG unites over 10,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, and New Zealand in the fight against childhood cancer. Today, more than 90% of the 16,000 children and adolescents diagnosed with cancer each year in the United States are cared for at COG member institutions. Research performed by COG institutions over the past 50 years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 80%. COG’s mission is to improve the cure rate and outcomes for all children with cancer.

COG PEP-CTN, funded by the NCI, is the largest early phase trial organization devoted to pediatric cancer, leveraging the expertise of 21 selected institutions within the COG based on their experience in new therapies for childhood cancer. The COG PEP-CTN designs and conducts pediatric early phase trials including phase 1 trials that often include phase 2 expansion cohorts. In addition, the PEP-CTN conducts pilot studies of novel agents/regimens to determine their tolerability so that promising agents/regimens can proceed to definitive testing in phase 3 clinical trials

About Texas Children’s Hospital
Texas Children’s Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children’s hospital in Texas, and among the top in the nation, Texas Children’s has garnered widespread recognition for its expertise and breakthroughs in pediatric and women’s health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for Pediatric Research; Texas Children’s Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children’s Hospital West Campus, a community hospital in suburban West Houston; and Texas Children’s Hospital The Woodlands, the first hospital devoted to children’s care for communities north of Houston. The organization also created Texas Children’s Health Plan, the nation’s first HMO for children; Texas Children’s Pediatrics, the largest pediatric primary care network in the country; Texas Children’s Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that’s channeling care to children and women all over the world. Texas Children’s Hospital is affiliated with Baylor College of Medicine. For more information, go to www.texaschildrens.org.

About Baylor College of Medicine
Baylor College of Medicine is a health sciences university that creates knowledge and applies science and discoveries to further education, healthcare and community service locally and globally.

It is the only private medical school in the greater southwest and is ranked 22^nd among medical schools for research and 17^th  for primary care by U.S. News & World Report. The Baylor pediatrics program is ranked 7^th  among all pediatric programs, reflecting the strong affiliation with Texas Children’s Hospital where our faculty care for pediatric patients and our students and residents train. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Luke’s Medical Center, part of CHI St. Luke’s Health. More information on Baylor College of Medicine may be found on the website, https://www.bcm.edu/.

¹ CA Cancer J Clin 2021; 71:7-33
² Steliarova-Foucher E, Colombet M, Ries LAG, et al. International incidence of childhood cancer, 2001-10: a population-based registry study. Lancet Oncol. 2017;18(6):719-731.
³ N Engl J Med 2018; 379:2468-2475 DOI: 10.1056/NEJMsr1804754

For more information:

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

SOURCE Iterion Therapeutics

Antiva Biosciences, a biopharmaceutical company developing novel, topical therapeutics for the treatment of pre-cancerous lesions caused by human papilloma virus (HPV) infection, today announced the closing of a $31 million Series D equity financing. The financing was supported by a syndicate of premier life science investors led by Adjuvant Capital, a leading global and women’s health venture firm, and joined by GV, formerly Google Ventures. Participants in the financing also included new investors HBM Healthcare Investments, Avestria Ventures, Gaingels and Mana Ventures, as well as existing investors including Canaan Partners, Sofinnova Ventures, Lumira Ventures, Brace Pharma Capital, Sirona Capital, Osage University Partners, Dong-A ST and Alexandria Venture Investments. In conjunction with the financing, Jenny Yip, Managing Partner, Adjuvant Capital, will join Antiva’s board of directors.

Proceeds from the financing will support the continued development of the company’s lead development candidate, ABI-2280, including the near-term advancement of the compound into Phase 1 and 2a clinical trials as a potential treatment for high-grade cervical intraepithelial neoplasias (HSIL, CIN 2,3). ABI-2280 is a prodrug of an acyclic nucleoside phosphonate with known potent antiviral activity which works by directly blocking HPV replication and inducing apoptosis in HPV-infected lesions, while sparing normal cells. Antiva has leveraged its development expertise to create a topical formulation of the compound that is rapidly taken up into epithelial cells, avoiding the potential systemic toxicity often seen when potent antiviral drugs are delivered systemically.  The company intends to initiate a Phase 1 clinical trial of ABI-2280 during the fourth quarter, with data expected in the first half of 2022.

“This round of financing comes at an active and exciting time for Antiva, as we rapidly approach the initiation of our first-in-human Phase 1 clinical trial of ABI-2280. With industry-wide interest continuing to grow in the global health and women’s health sectors, we feel that ABI-2280 is strongly positioned to meet several critical unmet needs in these areas,” said Gail Maderis, President and CEO of Antiva. “As a non-surgical treatment, ABI-2280 has the potential to offer a therapeutic that can preserve women’s reproductive health, be self-administered at home, and improve access to care in underserved communities where OB/GYN resources are scarce. These attributes are particularly valuable in lower- and middle-income countries (LMIC) , which account for the majority of the more than 300,000 annual deaths from cervical cancer worldwide.”

“As an investor targeting companies tackling high-burden public health challenges in historically overlooked market segments, we feel that Antiva fits our investment approach perfectly. By leveraging a novel technology to develop a topical treatment for HPV-related diseases that often progress into invasive cancers, Antiva is working to address a major global unmet clinical need with a goal of increasing treatment access to women throughout the world,” said Ms. Yip. “We are proud to support the company’s efforts in this area and look forward to the ongoing development of ABI-2280 as it enters the clinic.”

In conjunction with the close of the Series D financing, Antiva and Adjuvant are establishing a global health committee designed to accelerate global development and commercialization of ABI-2280 in lower and middle income countries. The committee will be led by Clifford Samuel, a member of Antiva’s board of directors and formerly Senior Vice President of Global Patient Solutions at Gilead, who brings more than two decades of experience developing and commercializing global health therapeutics.

About HPV-Related Diseases and Cervical Cancer

Human Papilloma Virus (HPV) is so common that nearly all sexually active men and women are infected with the virus at some point in their lives. While many of these are transient infections which the body is capable of fighting off, the infections that persist are known to drive the formation of malignancies, including cervical, anal, vulvar, penile, and head and neck cancers.

The introduction of prophylactic vaccines for HPV was a major step forward in the fight against HPV-associated cancers by preventing infection by certain high-risk HPV subtypes. However, due to low adoption rates in the US, EU, and Japan, and limited access to the vaccines in developing countries, HPV infections and the disease states driven by such infections remain a major unmet clinical need.

Globally, cervical cancer is the fourth most common cancer in women and as such represents a major public health problem. According to the World Health Organization, an estimated 570,000 women were diagnosed with cervical cancer worldwide and approximately 311,000 women died from the disease in 2018.

About Antiva Biosciences
Antiva Biosciences, Inc. is a clinical-stage biopharmaceutical company developing novel, topical therapeutics for the treatment of diseases caused by HPV infection. The company, based in South San Francisco, was founded in 2012 by Dr. Karl Hostetler of The University of California San Diego. The company’s lead drug candidate, ABI-2280 is initially being developed as a topical treatment for high-grade cervical intraepithelial neoplasias (HSIL, CIN 2,3). Antiva believes that development of ABI-2280 may also be expanded to include other pre-cancers attributed to HPV, such as vulvar (VIN 2,3) and anal (AIN 2,3) neoplasias. 

For more information, please visit: www.antivabio.com.

Contact Information:
Gail Maderis
Antiva Biosciences, Inc.
650-822-1401
gmaderis@antivabio.com

Tim Brons 
Vida Strategic Partners (media)
646-319-8981
tbrons@vidasp.com

SOURCE Antiva Biosciences, Inc.

Enrollment for Phase 1 Clinical Trial to Commence by End of 2021

BioTheryX, Inc., a clinical-stage company focused on targeted protein degradation to create life-saving medicines, today announced that the U.S. Food and Drug Administration (FDA) cleared the company to proceed with a Phase 1 clinical trial of BTX-1188 in hematologic and solid malignancies. 

BTX-1188 is a novel oral small molecule cereblon binder that has immunomodulatory properties and promotes the degradation of a neosubstrate G1 to S phase transition 1 (GSPT1), a translation termination factor, as well as IKZF1/3, zinc finger transcription factors important in hematological function. By degrading multiple proteins including GSPT1 and IKZF1/3, BTX-1188’s profile is expected to be differentiated from protein degraders that exclusively target GSPT1. BTX-1188 has demonstrated promising preclinical activity against a variety of leukemias and solid tumors.

“The FDA clearance to begin our Phase 1 study for BTX-1188 is a major milestone for BioTheryX, which represents our first molecular glue to enter clinical development, and the second IND clearance for our pipeline,” said Zung Thai, M.D., Ph.D., Chief Medical Officer of BioTheryX. “We plan to study BTX-1188 in patients with hematological and solid malignancies who have limited treatment options and for whom new therapies are desperately needed. We expect to initiate patient enrollment in the Phase I study by year end.”

The Phase I clinical trial is designed to assess the safety and tolerability of BTX-1188 and to determine the recommended Phase 2 dose. Following determination of the recommended Phase 2 dose, the company plans to further evaluate the safety and efficacy of BTX-1188 in expansion cohorts in both hematological and solid tumor malignancies.

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, ‘molecular glues’ and PROTACs, 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 on LinkedIn.

Antios Therapeutics, Inc. (“Antios”), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), today announced the successful closing of a $75 million Series B-1 financing. The financing round was co-led by GordonMD Global Investments, a firm focused on investments in private and publicly traded global growth and innovative biopharma companies primarily located in the United States, Japan, and Europe.

The proceeds from this financing will be used to advance the clinical development of ATI-2173, Antios’ lead Phase 2b clinical candidate. ATI-2173 is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development and has the potential, if approved, to become the cornerstone of a curative, once-daily HBV therapy. Pre-clinical data to date for ATI-2173, alone or combined with tenofovir disoproxil fumarate (TDF), indicate the potential for sustained HBV DNA suppression off treatment, unique among approved nucleosides and investigational anti-HBV therapies.

“We are pleased to add GordonMD Global Investments to our existing group of high-caliber healthcare investors. Their excitement reflects a shared recognition that, if approved, ATI-2173 has the potential to be a convenient, once-daily regimen that could offer hope for millions of HBV-infected individuals worldwide,” said Greg Mayes, Chief Executive Officer of Antios. “This round of investment enables us to accelerate the Phase 2b clinical development of ATI-2173, which has already demonstrated potent on-treatment and durable off-treatment effects, while being generally well-tolerated, in our Phase 1b study in patients with HBV.”

“Antios’ unique approach to developing potentially curative therapies for HBV and other viral diseases, and the strong results from the Phase 1b clinical trial data of ATI-2173, are impressive,” said Craig Gordon, MD, Founder, CEO and CIO of GordonMD Global Investments. “We believe in the mission that Antios’ management and clinical teams are driving forward and are excited to be a part of their next phase of growth.” The EPIQ Capital Group co-led the investment with GordonMD Global Investments and new healthcare investors include Avego BioScience Capital and Heartland Healthcare Capital. All investors in the prior rounds of

investment participated in the Series B-1 raise. Healthcare investors from previous funding rounds include CAM Capital, Delos Capital, Lumira Ventures, Domain Partners IX L.P., Adage Capital Management L.P., Fonds de solidarité des travailleurs du Québec (FTQ), Sixty Degree Capital, Pontifax, RA Capital Management, Soleus Capital, Aisling Capital, Amzak Health, Granite Point Capital Management, L.P., LifeSci Venture Partners, GRA Venture Fund and Altium Capital.

As part of the funding announcement, Antios also announced that Dr. Gordon will join the Antios Board of Directors.

About ATI-2173

ATI-2173, Antios Therapeutics’ lead once-daily, oral drug candidate for treating HBV, is an investigational phosphoramidate prodrug of clevudine monophosphate. ATI-2173 has the potential, if approved, to become the cornerstone of a curative HBV regimen. It is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development and its mechanism of action is complementary to other approaches that also seek to achieve a functional cure. ATI-2173 is currently in Phase 2b clinical development. The SAVE-1 (Sustained Anti-Viral Efficacy) trial is an ongoing, double-blind, randomized, placebo-controlled study of 30 patients designed to assess the safety and efficacy of 25 and 50 mg doses of ATI-2173 daily for 90 days in combination with tenofovir disoproxil fumarate (TDF) compared with TDF plus ATI-placebo (control) in chronic HBV-infected subjects.

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. Its lead drug candidate ATI-2173 – the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development – has the potential, if approved, to become the cornerstone of a curative therapeutic regimen for chronic HBV, a major unmet global health problem affecting up to 300 million people worldwide, more than hepatitis C and HIV combined. For more information, please visit www.antiostherapeutics.com.

ANTIOS CONTACTS

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

Media:
Jenny Hooper
JPA Health
jhooper@jpa.com  
+1 (202) 899-5379 / +1 (956) 638-5095

GORDONMD GLOBAL INVESTMENTS CONTACT

Media:

Mitch Ackles Hedge Fund PR

mitch@hedgefundpr.net

+1 (646) 657-9230

Company Strategically Strengthens its Fight Against Long QT Syndrome with Novel Kinase Drug Development Expertise

Today, LQT Therapeutics, Inc. (LQTT) announced the addition of Dr. Robert Booth to its Board of Directors. Dr. Booth brings more than 30 years of biopharmaceutical industry experience to the company, most recently as founder and chief executive officer of Virobay Inc. In addition, he has served as operating partner and senior advisor at TPG Biotech.

“A major objective for us at LQTT after our recent Series A financing, has been to enrich our board of directors with experienced, respected and highly accomplished drug development executives as we continue to advance our clinical programs,” said Paul F. Truex, Chairman and Chief Executive Officer of LQT Therapeutics.“Robert has extensive strategic and operational experience in early-stage drug development and specifically with the development of commercially successful kinase inhibitors. Robert is a veteran of the industry, and a superb scientist with wide-ranging expertise in many aspects of drug development and a particular focus in supporting the advancement of novel therapies for important diseases for which the existing treatment options are suboptimal.”

Prior to Virobay, Dr. Booth was the chief scientific officer at Celera Genomics, where he was responsible for all discovery and development activities. He conceived and initiated the BTK inhibitor program that was ultimately licensed to Pharmacyclics, and from which Imbruvica was developed and approved. Imbruvica is a novel kinase inhibitor used for the treatment of many B cell non-Hodgkin’s lymphomas (NHL). Dr. Booth served on the board of directors of Pharmacyclics until its acquisition by AbbVie. Prior to Celera, he was senior vice president for Roche in Palo Alto, California. He was a member of the global research management team and the business development committee, which oversaw licensing opportunities. Dr. Booth received his BSc and PhD in biochemistry from the University of London.

About LQT Therapeutics, Inc.

LQT Therapeutics, Inc. is pioneering a precision medicine approach to treat patients with Long QT Syndrome and other arrhythmias based on research developed at Beth Israel Deacons Medical Center, Massachusetts General Hospital, and Sanofi, S.A. By combining leading-edge cardiovascular genetics and diagnostics with recent advances in the understanding of the role of SGK1, LQT Therapeutics seeks to make a meaningful difference in the lives of people suffering from Long QT Syndrome and resistant cancers. Launched in 2019 by the Fonds de Solidarité FTQ. LQT Therapeutics, Inc. was founded by world-class experts in cardiovascular disease, cardiac muscle biology and drug development. For more information, please visit www.lqttrx.com

For more information:

Daphne Doucet | daphne@lqttrx.com | 514-973-0915

BioTheryX, Inc., a clinical-stage company focused on targeted protein degradation to create life-saving medicines, today announced the appointment of Philippe Drouet as President and Chief Executive Officer of BioTheryX.

“Philippe is an extremely talented biopharma executive with more than two decades of global experience in commercializing blockbuster oncology therapeutics. He has worked to advance products through clinical development, successfully launched them, and most importantly made them available to patients. His proven track record in building effective high performing teams will position us well to advance our pipeline of protein degraders and modulators to create life-saving medicines for patients,” said David Stirling, Ph.D., Executive Chairman of BioTheryX. “The Board and I welcome him as CEO, and we are excited to have him lead our company as we build on our expertise in protein modulation-based drug development.”

Prior to joining BioTheryX, Mr. Drouet served as Chief Commercial Officer at CRISPR Therapeutics where he shaped the strategy for the launch of the company’s first allogeneic CAR-T therapies and helped lead the clinical development strategy for the company’s phase I clinical assets. Previously, Philippe served as Senior Vice President, Global Oncology at Merck & Co. where he launched and commercialized Keytruda®, drove substantial global oncology revenue and built and led the company’s Global Oncology Marketing, Access and Pricing organization.  Prior to that, he served as President of Hospira’s U.S. division before Hospira’s acquisition by Pfizer in 2015. Philippe also held roles of increasing responsibility at Novartis Pharmaceutical Corporation, including Vice President U.S. Hematology, General Manager Oncology in Turkey, Global Brand Leader for Gleevec® and Head of Oncology Marketing in Canada. Philippe received an MBA from INSEAD in France and a Master of Science and Bachelor in Chemical Engineering from McGill University, Canada.

“I am excited to join BioTheryX and lead the company through its next stage of rapid growth as it expands its programs in the fast-paced category of protein degradation,” said Mr. Drouet. “BioTheryX has built one of the leading scientific teams and most promising pipelines in the protein degradation space. I look forward to working alongside this outstanding team to build our clinical-stage program for liquid and solid tumors and develop first-in-class therapies in areas of high unmet medical need in oncology and other diseases.”

About BioTheryX, Inc.

BioTheryX is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from cancer and inflammatory and immunological diseases through the discovery, development and commercialization of therapies that restore protein homeostasis through targeted protein degradation and modulation, and multi-kinase inhibition. They leverage their proprietary Protein Homeostatic Modulator technology platform and differentiated targeted protein degradation approach to design small molecules that regulate protein homeostasis. BioTheryX believes their approach is applicable to a broad range of diseases, in particular those driven by protein targets that have been considered undruggable. The initial programs are focused on oncology indications with high unmet medical need.

For more information, please visit www.biotheryx.com 

GenEp, Inc., a biotechnology company developing therapies that address unmet needs in patients with epilepsy, announced today the closing of a $1.45 million seed financing. The financing was co-led by the UVA Licensing & Ventures Group Seed Fund, Angelini Lumira Biosciences Fund and 3B Future Health Fund, with additional participation by the Virginia Innovation Partnership Corporation, Kids Connect Charitable Fund, PDI Ventures and the company’s management team. GenEp is developing first-in-class, highly selective compounds that modulate sodium channels. Nav1.6 & Nav1.2 gain of function mutations drive uncontrolled seizures and result in treatment resistance in certain rare genetic epilepsies and other treatment resistant epilepsies.

“We are grateful to our investors for their confidence in our team and our science,” said Andrew J. Krouse, President and Chief Executive Officer of GenEp. “Their financial support and deep industry experience will enable our company to make a difference in the lives of children and families living with epilepsy.”

The company’s proprietary mouse audiogenic reflex seizure model (MARS^TM) allows it to rapidly screen many compounds in vivo in a clinically relevant model of human SCN8A epileptic encephalopathy, a rare pediatric disease caused by gain of function mutation in the Nav1.6 channel. Based on the University of Virginia’s Dr. Manoj Patel’s therapeutic insight that targeting the CNS isoforms of the Nav channel (Nav1.6, Nav1.2, and Nav1.1) to control seizures would be superior to targeting only Nav1.6, GenEp is optimizing its patented first series of CNS- specific sodium channel inhibitors to decrease over-active neuronal signaling while limiting off-target safety effects common to other isoforms and ion channels.

“We are excited to join in accelerating GenEp’s important pediatric genetic epilepsy programs,” stated Gerry Brunk, Managing Director of Lumira Ventures, manager of the Angelini Lumira Biosciences Fund. “GenEp’s experienced management team (whose previous company Cavion was acquired by Jazz Pharmaceuticals in 2019), patented compounds, and innovative drug screening model offer a compelling opportunity to develop effective therapies for these patients’ unmet medical needs.”

In connection with the financing, Gerry Brunk and Marianne Bjordal of 3B Future Health Fund will join CEO Andrew Krouse on the GenEp Board of Directors.

About GenEp, Inc.

GenEp, Inc. is a privately held pre-clinical stage biotechnology company based on intellectual property assets licensed from the University of Virginia. GenEp aims to create therapies targeting mutations of sodium and other ion channels that cause rare genetic epilepsies and other treatment-resistant epilepsies.

About the UVA Licensing & Ventures Group

The Licensing & Ventures Group (LVG) is the intellectual property management and innovation commercialization organization for the University of Virginia (UVA) research enterprise. Founded in 1977, its mission is to maximize the intellectual, societal, and economic impact of UVA discoveries via commercialization to enrich and improve lives for the University, the Commonwealth of Virginia, and the world. The LVG Seed Fund is a $10MM evergreen fund that is uniquely positioned to launch and support new ventures emerging from the UVA research portfolio. The Fund is governed by an oversight committee comprised of leaders in early-stage investing and startup development who are all UVA alumni. To learn more visit lvg.virginia.edu.

About Angelini Lumira Biosciences Fund

Angelini Lumira Biosciences Fund is a corporate venture capital fund established by Angelini Pharma, an international pharmaceutical company, part of the Italian privately-owned Angelini Group. Angelini Pharma is committed to helping patients in the therapeutics areas of central nervous system and mental health, rare diseases, and consumer healthcare. Angelini Pharma operates directly in 25 countries employing almost 3,000 people and commercializes its products in more than 70 countries through strategic alliances with leading international pharmaceutical groups. Lumira Ventures is a North American healthcare venture capital firm with a two-decades of experience of investing in and helping to build transformative biomedical companies. Lumira Ventures manages its activities from offices in Toronto, Montréal, Vancouver and Boston.  For more information, please visit www.lumiraventures.com 

About 3B Future Health Fund S.A. SICAR, formerly known as Helsinn Investment Fund S.A., SICAR

3B Future Health Fund is focused on investments in areas of high unmet patient need. Backed by the Helsinn Group, and guided by Helsinn’s core values of quality, integrity, and respect, 3B Future Health Fund aims to help companies with innovative technologies to transform new ideas into commercial solutions with the potential to impact health-related quality of life of patients. Drawing on Helsinn’s over 40 years of investment into research and development and commercial expertise, the investment fund selects companies with technologies in a range of areas including cancer therapeutics and diagnostics, cancer supportive care, metabolic and gastrointestinal disorders, and dermatology conditions. For more information, please visit 3bfuturehealth.com.

Forward-Looking Statement

This press release contains forward-looking statements that are subject to risks and uncertainties and includes statements that are not historical facts. Actual results could differ significantly from results discussed. GenEp, Inc. disclaims any intent or obligation to update forward-looking statements, except as required by law.

For more information:

GenEp, Inc.
Andrew Krouse
434-989-6299
akrouse@genepbio.com

Iterion Therapeutics, Inc., a venture-backed, clinical-stage biotechnology company developing novel cancer therapeutics, today announced the initiation of a Phase 1 clinical trial to investigate tegavivint as a potential treatment for acute myeloid leukemia (AML). This investigator-initiated trial is being led by Tapan M. Kadia, M.D., from the Department of Leukemia at The University of Texas MD Anderson Cancer Center.

Tegavivint is a potent and selective first-in-class inhibitor of Transducin βeta-like Protein One (TBL1), a novel downstream target in the Wnt/beta-catenin signaling pathway. Binding of TBL1 to beta-catenin in the nucleus is necessary for activation of beta-catenin-dependent gene transcription. Tegavivint’s targeting of TBL1 prevents the TBL1/beta-catenin complex from forming and specifically inhibits beta-catenin’s oncogenic activity without disrupting key cell membrane functions that have been linked to toxicity common to other drugs in this pathway.

“We are very excited about this trial to research tegavivint as a potential new treatment for AML, the most common type of leukemia in adults,” stated Rahul Aras, Ph.D., CEO of Iterion Therapeutics. “Having recently established the drug’s safety and clinical activity in a proof-of-concept Phase 1 study in desmoid tumors, we are expanding our clinical footprint to address additional cancers characterized by beta-catenin overexpression such as AML, NSCLC and certain pediatric cancers. The initiation of the AML clinical trial represents an important advance in this growth strategy.”

Aberrant up-regulation of beta-catenin has been documented as essential for self-renewal, growth and survival of AML stem and blast progenitor cells. In AML preclinical models, tegavivint has shown single agent and combination efficacy with chemotherapy and targeted agents, without affecting normal hematopoietic stem cells. The Phase 1 trial is designed as a two-part, open-label, dose-escalation study to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of tegavivint, as a monotherapy and in combination with decitabine, in patients with relapsed and refractory AML.

More information on the clinical trial is available at https://clinicaltrials.gov/ct2/show/NCT04874480?term=Tegavivint&draw=2&rank=2.

“We welcome the opportunity to initiate this clinical trial of tegavivint, which targets TBL1, a novel therapeutic target in the Wnt-signaling pathway that has been implicated by several groups in the progression of AML,” said Casey Cunningham, M.D., Chief Medical Officer of Iterion Therapeutics.  “This trial builds upon prior published research from MD Anderson led by Dr. Kapil N. Bhalla that defined the importance of the TBL1/beta-catenin biology in AML and the therapeutic potential for tegavivint in this patient population.”

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 small molecule that binds to TBL1 in the nucleus inhibiting nuclear beta-catenin signaling and oncogenic activity. 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 and a Phase 1 clinical trial in patients with relapsed or refractory acute myeloid leukemia (AML). Iterion is also pursuing clinical programs in additional cancers where nuclear beta-catenin signaling has been shown to play a role, such as 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.

HistoSonics, the developer and manufacturer of a non-invasive platform and novel sonic beam therapy called histotripsy, announced today that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its new therapy platform. Histotripsy of the liver provides clinicians the first automated external beam therapy using acoustic energy to mechanically destroy and liquefy tissue in the liver without incisions, ionizing radiation or heat.

“The Breakthrough Device Designation is a significant milestone for our company and validates our belief that our platform offers significant advantages over existing approved or cleared alternatives, per FDA requirements,” said Mike Blue, President and CEO of HistoSonics. “Early and ongoing clinical results are promising and suggest that our ability to precisely destroy targeted liver tissue, completely non-invasively, and without the challenges associated with ionizing radiation or other locoregional therapies, provides advantages to patients and physicians that don’t exist today, and we look forward to working with the FDA to make the technology accessible as quickly as possible.” 

The company believes the novel mechanism of action of their proprietary technology may offer significant advantages to patients, including equivalent treatment effect throughout the entire treatment volume resulting in precise and predictable treatment zones. Early clinical and pre-clinical results also suggest that histotripsy largely preserves critical structures such as the liver capsule, and larger vessels and ducts within or adjacent to the treated volume of tissue. Additionally, histotripsy enables the treating physicians the ability to monitor the destruction of tissue under continuous real time visualization and control, unlike any modality that exists today. The Breakthrough Designation will allow the company to engage with the FDA in a prioritized review during the regulatory market authorization process.

HistoSonics has worked cooperatively with the FDA for over 3 years in developing pre-clinical and clinical data required for regulatory market authorization and intends to continue collaborating with the Agency throughout the ongoing Investigational Device Exemption (IDE) Study, #HOPE4LIVER US, which is designed to evaluate the safety and technical efficacy of histotripsy in patients with primary and secondary liver tumors. The company plans to share US and European #HOPE4LIVER Study data and results with FDA to demonstrate the benefits of histotripsy in a broad patient population.

The HistoSonics System 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™ Platform, global clinical studies, and new strategic projects including future clinical applications and platforms. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, Minnesota.

For more information please visit: www.histosonics.com

SOURCE HistoSonics, Inc.

QUEBEC, Quebec, October 13, 2021 – OpSens Inc. (TSX:OPS), a cardiology medical device company providing innovative product solutions based on its patented optical technology, is pleased to announce the commencement of the human clinical study utilizing the SavvyWire, and successful treatment of the first patients. The SavvyWire, developed initially for transcatheter aortic valve replacement (“TAVR”), is the first guidewire intended to both deliver a valvular prosthesis while allowing continuous hemodynamic pressure measurement during the procedure.

“We are extremely pleased to have commenced this important safety study with the first two patients  successfully treated with the SavvyWire. Structural heart procedures are  a rapidly growing market, driven by the TAVR procedure and the expansion of its indications,” said OpSens President and Chief Executive Officer, Louis Laflamme. “As the TAVR procedure continues to benefit a wider range of patients and the minimalist approach grows in popularity, the benefit of a product like the SavvyWire could be significant. The SavvyWire is an active guidewire that allows physicians to deliver the valve, monitor deployment, and ensure optimal implantation without guidewire exchanges. We believe this could have procedural benefits and improve the security and efficiency of the procedure.”

Treatment of the first patients in the SavvyWire clinical study

The study will be conducted on 20 patients in two world renowned structural heart institutions with Dr. Josep Rodés-Cabau at the Quebec Heart and Lung Institute (Institut Universitaire de Cardiologie et de Pneumologie de Québec or “IUCPQ”), in Quebec City and Dr. Réda Ibrahim at The Montreal Heart Institute (“MHI”) in Montreal, as primary investigators.

Dr. Rodés-Cabau and Dr. Ibrahim mentioned, “Our two major cardiology centers in Quebec (IUCPQ and MHI), are proud to collaborate in the optimization of TAVR procedures by working with OpSens, an innovative Company on the cutting-edge of medical technology in the field of cardiology. In the first cases performed simultaneously in Quebec City and Montreal, we were able to successfully deploy the two dominant valves on the market, an Edwards Sapien 3 Ultra valve in one patient and a Medtronic CoreValve Evolut Pro Plus in the other. This demonstrated the initial versatility of the SavvyWire.”

The SavvyWire, a new intelligent, pre-shaped, structural guidewire with integrated pressure monitoring, aims at improving procedural efficiency and clinical outcomes by allowing multiple steps over the same device without exchange. This device has been designed to support the minimalist TAVR approach which has been growing among structural heart physicians. With the SavvyWire, physicians can expect to diagnose and implant the percutaneous valve over the same device while getting continuous and accurate hemodynamic measurements. OpSens is targeting the commercial launch of its SavvyWire in calendar year 2022.

TAVR Procedure Evolution

Aortic valve stenosis occurs when the heart’s aortic valve narrows, which prevents the valve from opening fully, restricting blood flow from the heart into the main artery (aorta) and onward to the rest of the body.

Initially, the TAVR procedure was only indicated for inoperable patients and then for high-risk surgical patients. Clinical programs like PARTNER or COREVALVE, have since shown better or equivalent clinical outcomes in intermediate and low-risk patients. The TAVR procedure is now evolving quickly with a minimalist approach that allows the procedure to be faster and the patients to be discharged earlier, sometimes on the same day.

The TAVR procedure is on the rise, driven by an aging of the population and recent studies that demonstrate its benefits to patients of all conditions. The TAVR market is currently estimated at US$5 billion and is expected to reach US$8 billion by 2025.

For more information, please contact:

Louis Laflamme, CPA, CA, Chief Executive Officer, 418.781.0333

Robin Villeneuve, CPA, CA Chief Financial Officer, 418.781.0333

LQT Therapeutics, Inc. (LQTT) a pharmaceutical company pioneering the development of precision therapies for genetic heart diseases, today announced the successful completion of a US$19 million Series A financing.  LQTT is advancing a series of in-licensed compounds discovered and developed by Sanofi S.A. (Paris, France) which inhibit Serum/Glucocorticoid Regulated Kinase 1 (SGK1).  Recent research conducted by the company’s founders confirmed the role of this novel kinase as a key contributor of inappropriate sodium regulation in various arrhythmias including Long QT Syndrome.  Further investigation also validated the effects of SGK1 inhibition on cell proliferation pathways in prostate and colorectal cancers.  Additional roles for upregulated activated SGK1 on various metabolic pathways continue to be discovered which LQTT intends to explore opportunistically. 

Over the past 12 months LQTT has successfully reproduced the positive effects of SGK1 inhibition in stem-cells of patients with Long QT Syndrome and various in vitro models of cell proliferation for prostate cancer and anticipates presenting this new data at an upcoming scientific conference.  Based on this data LQTT has designated a series of promising SGK1 inhibitors for IND-enabling studies and eventual human use.  Proceeds from this financing will advance and expand the company’s portfolio of SGK1 inhibitors through phase 1 human clinical studies. 

“The enthusiasm from our investors is a reflection of breakthrough science, hard work and dedication of our scientists, founders and collaborators all sharing a vision to transform the lives of patients suffering from Long QT Syndrome and other devastating diseases,” said Paul F. Truex, Chairman and Chief Executive Officer of LQT Therapeutics. “The investment of resources and expertise by our new shareholders and Sanofi’s willingness to provide exclusive access to their intellectual property will be instrumental for us to advance our therapeutic programs.  We are thankful for the efforts of our founders Dr. Anthony Rosenzweig, Dr. David Milan and Dr. Saumya Das, whose initial research uncovered this truly novel approach to treat rare arrhythmias and Dr. Marc Vidal who worked tirelessly over the past 18 months to advance our research while serving as a member of our Board of Directors.”

The Series A financing was led by Amplitude Ventures and included new investments from Lumira Ventures, Amzak Health, Alexandria Venture Investments, founding investor Fonds de solidarité FTQ, founding scientists and members of the management team.  As part of the financing Jean-François Pariseau from Amplitude, Daniel Hétu, MD from Lumira Ventures, and Scott Weiner from Amzak Health will join the Board of Directors.  Additionally, Dr. Debra Odink will join the company as Chief Development Officer and Senior Vice President of Technical Operations. Having started her career at Roche, Dr. Odink spent the last 25 years in various leadership roles across multiple disease areas culminating in the successful commercialization of several pharmaceutical products and corporate outcomes.  Dr. Philip Sager will join the company as Chief Medical Officer to provide regulatory and clinical development guidance to the company’s lead program.  Finally, Dr. Saumya Das, a founder will continue to provide clinical and scientific expertise to our Long QT Syndrome program. 

“Looking back at the progress that Paul, the founders and the LQTT team have made since we seeded this team in 2019 is so exciting,” added Geneviève Guertin, Vice President for Investments, Life Sciences at Fonds de solidarité FTQ. “This project is the first of a new initiative in which the Fonds acts as a founding shareholder along with successful entrepreneurs. We are pleased to be joined today by such a great group of investors, with whom we will support LQTT into its next phase”

“We’re excited to partner once again with this highly-skilled management team to support LQTT’s goals in becoming a leader in precision cardiology”, commented Jean-François Pariseau, co-founder and partner at Amplitude Ventures.  “Rare and orphan cardiovascular diseases are a high need area—ideal for a more precision approach for diagnosis and treatment” Inquiries:  Info@lqttrx.com

About LQT Therapeutics

LQT Therapeutics, Inc. is pioneering a precision medicine approach to treat patients with Long QT Syndrome and potentially other arrhythmias based on research from Beth Israel Deacons Medical Center, Massachusetts General Hospital, and Sanofi, S.A. By combining leading-edge cardiovascular genetics and diagnostics with recent advances in the understanding of the role of SGK1, LQT Therapeutics seeks to make a meaningful difference in the lives of people suffering from Long QT Syndrome and resistant cancers.  Launched in 2019 by the Fonds de solidarité FTQ.  LQT Therapeutics was founded by world-class experts in cardiovascular disease, cardiac muscle biology and drug development. For more information, please visit www.lqttrx.com

About Our Investors

Amplitude Ventures
Amplitude is a full-stack venture capital firm using a unique growth model to build Canadian companies with world-class management teams and scale companies to breakout potential. With over $300M under management and offices in Montreal, Toronto and Vancouver, Amplitude applies a proven, evidence-based approach to investing in leading precision medicine companies. Visit www.amplitudevc.com

The Fonds de solidarité FTQ
The Fonds de solidarité FTQ invests to build a better society by channeling the savings of its 723,501 shareholders into development and risk capital investments to help Québec transition to a green economy, to a human-centered world of work, and to a healthier society. The Fonds offers businesses unsecured financing and strategic support. With $17.2 billion in net assets as at May 31, 2021, the Fonds has supported 3,437 partner companies and 247,612 jobs. For more information, visit www.fondsftq.com

Lumira Ventures
Lumira Ventures is a North American healthcare venture capital firm with a two-decade track record of investing in transformative biomedical companies.  It is a multi-stage investor that partners with mission-driven entrepreneurs and like-minded investors to build innovative companies in the biotechnology, medical device and digital health sectors.  These companies are harnessing rapidly evolving innovations in genomics, cell therapy, gene therapy, bioengineering, robotics and artificial intelligence to develop high impact, often transformative products for patients while generating exceptional returns for their investors and meaningful economic value to society. To date, Lumira’s companies have brought dozens of biomedical innovations to the market, impacting the lives of over 1 billion patients worldwide and generating over $70 billion of cumulative revenue. Lumira Ventures manages its activities from offices in Toronto, Montréal, Vancouver and Boston.  For more information, please visit www.lumiraventures.com 

Amzak Health
Amzak Health is an evergreen fund that invests in private and select public life science companies across stages and geographies.  It seeks to invest in innovative biotech and medtech companies developing first in class or best in class treatments addressing areas of unmet medical need.  The Amzak Health team has significant investment and operating experience. Amzak Health approaches each investment with a long-term vision and prides itself on being knowledgeable and dependable partners. Amzak Heath is based in New York. https://amzak.com

Alexandria Venture Investments 
Alexandria Venture Investments is the Alexandria Real Estate’s strategic venture capital platform. Since its inception in 1996, it has invested in disruptive life science, agrifoodtech, and technology companies advancing transformative new modalities and platforms to meaningfully improve human health. www.are.com

SOURCE LQT Therapeutics Inc.

For further information: Inquiries: Info@lqttrx.com

Related Links

http://www.lqttrx.com

BioTheryX, Inc., a clinical-stage company focused on creating life-saving medicines through targeted protein degradation, today announced the appointments of Nancy Miller-Rich, John A. Hohneker, M.D., and Diantha Duvall to its Board of Directors.

“The wealth of biotech leadership and industry knowledge that Nancy, John, and Diantha bring to our board will be invaluable as we advance our pipeline and execute on our strategic goals,” said David Stirling, Ph.D., President and CEO of BioTheryX.  “Nancy is a veteran life sciences executive and board member with significant expertise in corporate and commercial strategy.  John brings extensive drug development experience to BioTheryX and has been instrumental in the approval and commercialization of seven drugs across multiple therapeutic categories.  Diantha is a well-respected public company executive with experience across a broad range of financial and business disciplines that underpin biotech and large pharmaceutical company operations.  We look forward to Nancy, John, and Diantha’s guidance as we aim to build a leading protein degradation company.”

Appointee Bios:

Nancy Miller-Rich has 35 years of experience in the healthcare industry, with significant expertise in business development and commercial strategy. Since September 2017, Ms. Miller-Rich has served as a consultant to the pharmaceutical industry. Previously, Ms. Miller-Rich served in a number of leadership roles at Merck & Co., Inc. and, prior to the merger of the two companies, at Schering-Plough Corporation, including most recently as Senior Vice President, Global Human Health Business Development & Licensing, Strategy and Commercial Support and as Group Vice President, Consumer Care Global New Ventures and Strategic Commercial Development. Prior to joining Schering-Plough, Ms. Miller-Rich served in a variety of commercial and marketing roles at Sandoz Pharmaceuticals and Sterling Drug, Inc. She is currently a director of Aldeyra Therapeutics, Inc., Intercept Pharmaceuticals, Kadmon Holdings, Inc., and 4D Molecular Therapeutics, Inc., as well as a board member of a number of private and not-for-profit entities. She received her B.S. in Business Administration, Marketing from Ithaca College in Ithaca, New York.

John A. Hohneker, M.D. brings over 30 years of drug development and leadership experience within the biotech and pharmaceutical industry to the BioTheryX board.  He has served in several key leadership roles including as President and CEO of Anokion SA and President of Research and Development at FORMA Therapeutics Inc., where he guided the Company’s transition from a discovery-stage biotech to one with multiple programs in clinical trials.  He also held several roles at Novartis AG, most recently as Senior Vice President and Global Head of Development for Immunology and Dermatology, where he led the development and registration of Cosentyx® and Ilaris®.  During his tenure at Novartis, Dr. Hohneker also played a key role in the development, approval, and commercialization of several products including Gleevec®, Tasigna®, Zometa®, Afinitor® and Exjade®.  Prior to joining Novartis, he held positions of increasing responsibility at Glaxo Wellcome and its legacy company, Burroughs Wellcome. He received an MD from the University of Medicine and Dentistry of New Jersey at Rutgers Medical School.  Dr. Hohneker completed his internship and residency in Internal Medicine and his fellowship in Medical Oncology at the University of North Carolina Hospitals.

Diantha Duvall is an experienced financial and business leader in the life sciences sector who currently serves as Chief Financial Officer of Genocea, a leading cancer immunotherapy company.  Prior to joining Genocea in 2019, Ms. Duvall held several positions of increasing responsibility including Vice President, Controller and Chief Accounting Officer at Bioverativ, Inc., U.S. and Global Commercial Controller at Biogen, and Executive Director at Merck and Co.  While at Merck, her experiences spanned roles in venture investment, business development, joint ventures, and alliances, as well as operational controls and technical accounting.  In addition, she gained extensive experience in SEC reporting, Sarbanes Oxley compliance, transaction support and risk management while at PricewaterhouseCoopers.  Ms. Duvall received a bachelor’s degree in Economics and Public Policy from Colby College and masters’ degrees in both Accounting and Business Administration from Northeastern University. Ms. Duvall is a Certified Public Accountant licensed in the state of Massachusetts.

About BioTheryX, Inc.

BioTheryX is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from cancer and inflammatory and immunological diseases through the discovery, development and commercialization of therapies that restore protein homeostasis through targeted protein degradation and modulation, and multi-kinase inhibition. We leverage our proprietary Protein Homeostatic Modulator technology platform and differentiated targeted protein degradation approach to design small molecules that regulate protein homeostasis. We believe our approach is applicable to a broad range of diseases, in particular those driven by protein targets that have been considered undruggable. Our initial programs are focused on oncology indications with high unmet medical need.  For more information, please visit www.biotheryx.com and engage with us on LinkedIn.

SOURCE BioTheryX, Inc.

HAMILTON, ON and BOSTON, July 28, 2021 — Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) applications for [²²⁵Ac]-FPI-1966 (FPI-1966) and imaging agent [¹¹¹In]-FPI-1967 (FPI-1967). FPI-1966 is a targeted alpha therapy (TAT) designed to use vofatamab, a human monoclonal antibody, to target and deliver actinium-225 to tumor sites expressing fibroblast growth factor 3 (FGFR3), a protein that is overexpressed in multiple tumor types, particularly head and neck and bladder cancers. FPI-1966 utilizes Fusion’s Fast-Clear™ linker to connect vofatamab to actinium-225.

“Leveraging Fusion’s platform and expertise developing targeted alpha therapies, we are excited to begin our second clinical program,” said Chief Executive Officer John Valliant, Ph.D. “FGFR3 is an established and validated cancer target which is found in multiple tumor types with substantial unmet need, notably head and neck and bladder cancers. We have an opportunity to selectively deliver alpha particles to these tumors and use precision radiation therapy as a new treatment paradigm. While the currently approved pan-FGFR inhibitor for bladder cancer requires the presence of a specific mutation, our approach requires only over-expression of FGFR3. If successful, this could provide an opportunity to treat a larger population of patients.”

Fusion plans to initiate a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing FGFR3 intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. The study employs a 3 + 3 dose escalation design to evaluate multiple ascending doses of FPI-1966. The first cohort will comprise four sub-groups in which various doses of non-radiolabeled vofatamab (“cold antibody”) will be evaluated to assess the impact of pre-dosing on tumor uptake. As part of the screening process, patients will be administered an imaging analogue of FPI-1966, FPI-1967, and only those who meet predefined tumor uptake and safety criteria will go on to receive FPI-1966.

About FPI-1966
[²²⁵Ac]-FPI-1966 is a targeted alpha therapy designed to target and deliver an alpha emitting medical isotope, actinium-225, to cancer cells expressing FGFR3; a receptor that is overexpressed on several tumor types, including head and neck and bladder cancers. FPI-1966 utilizes Fusion’s Fast-Clear™ linker to connect vofatamab, the human monoclonal antibody that targets FGFR3, with actinium-225. Vofatamab was previously evaluated as a therapeutic agent in a Phase 1b/2 trial and was reportedly well-tolerated.

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-1966. 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 March 31, 2021 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.

Investors and others should note that Fusion communicates with its investors and the public using the Fusion website, www.fusionpharma.com, including, but not limited to, company disclosures, investor presentations, SEC filings, and press releases. The information that Fusion posts on this website could be deemed to be material information. As a result, Fusion encourages investors, media and others interested to review the information that Fusion posts there on a regular basis.

SOUTH SAN FRANCISCO, Calif., July 28, 2021 (GLOBE NEWSWIRE) — Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced randomization of the first subject in its SUMMIT Phase 3 efficacy trial of STS101 for the acute treatment of migraine.

Satsuma’s President and Chief Executive Officer, John Kollins, commented, “We are pleased to have initiated the SUMMIT trial and begun randomizing subjects in accordance with our previously communicated timeline objectives. We believe the likelihood of success for SUMMIT is high given the utilization of the second-generation STS101 nasal delivery device and improved subject training in combination with the trial design and conduct adjustments we’ve made based on our analyses of results from the previous EMERGE Phase 3 trial. We believe SUMMIT will provide the basis for STS101, with subsequent FDA approval, to become the first and only DHE product to have established efficacy on the current standard and FDA-accepted endpoints for acute treatment of migraine in a randomized, placebo-controlled trial.”

The SUMMIT Phase 3 efficacy trial of STS101 is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in approximately 1,400 subjects with migraine that is being conducted in the United States. The SUMMIT study was designed in accordance with FDA recommendations outlined in the FDA Guidance Migraine: Developing Drugs for Acute Treatment, February 2018. The study design and conduct take into account learnings from the Company’s previously-completed EMERGE Phase 3 efficacy trial. After establishing full eligibility, SUMMIT trial participants are randomized (1:1) to receive either STS101 5.2 mg or matching placebo and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication. The co-primary endpoints of the SUMMIT trial, to be assessed at two hours after STS101 administration, are freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia or nausea). The trial is designed for greater than 99% statistical power for the freedom from pain endpoint and greater than 95% statistical power for the freedom from most bothersome symptom endpoint. In addition, the SUMMIT trial incorporates a number of secondary endpoints and prospective evaluations of the clinical performance of STS101 that could differentiate the clinical profile of STS101.

Consistent with its previous communications, Satsuma expects to report top-line data from the SUMMIT trial in the second half of 2022.

For further information regarding the STS101 SUMMIT Phase 3 efficacy trial, see www.ClinicalTrials.gov, identifier NCT04940390: A Randomized, Double-Blind, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine (SUMMIT). 

About Satsuma Pharmaceuticals and STS101

Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product, STS101, for the acute treatment of migraine. STS101 is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE), administered via Satsuma’s proprietary 2^nd-generation nasal delivery device.  STS101 is designed to provide significant benefits versus existing acute treatments for migraine, including the combination of quick and convenient self-administration and other clinical advantages, that current DHE liquid nasal spray products and injectable dosage forms lack. Satsuma’s dry powder DHE formulation has demonstrated fast absorption, rapid achievement of high DHE plasma concentrations which Satsuma believes is necessary for early efficacy, and sustained plasma levels over time with low dose to dose variability. STS101 also now incorporates an improved 2^nd-generation nasal delivery device designed to provide more consistent nasal dosing, irrespective of user administration technique. Although DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration processes and/or sub-optimal clinical performance, have limited the widespread use of DHE. Featuring a compact and convenient dosage form, STS101 is designed to overcome these shortcomings and provide patients an improved therapeutic solution for acutely treating migraines that consistently delivers robust clinical performance.

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.

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

• 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