OncoMyx Therapeutics, a privately-held oncolytic virus immunotherapy company, today announced the appointment of Robert Williamson as Chief Business and Chief Financial Officer. Mr. Williamson has more than two decades of experience in building, financing, and leading private and public biotechnology companies through critical phases of growth. At OncoMyx, Mr. Williamson will lead the business development and financing strategies to maximize the company’s pipeline of multi-armed myxoma immunotherapies for the treatment of solid tumors and hematological malignancies.

“Rob has a proven track record of establishing successful partnerships and executing financings that propel companies to the next stage,” said Steve Potts, Ph.D., MBA, cofounder and Chief Executive Officer of OncoMyx. “The addition of Rob to the team comes at a key moment for OncoMyx, as we look to advance our lead multi-armed myxoma immunotherapy into clinical trials as a novel platform to deliver multiple cancer-killing payloads in one therapeutic. I look forward to working closely with him to realize the potential of OncoMyx’s unique myxoma platform to become best-in-class components of novel immunotherapeutic regimens and to build OncoMyx into the next great oncology company that delivers lifesaving medicines for many difficult-to-treat cancers.”

“I’m impressed not only with the potential of OncoMyx’s platform to systemically deliver multiple immune-activating and anti-tumor agents, but also the team, who are industry leaders with the experience needed to advance novel targeted treatments for cancer patients into and through the clinic,” said Mr. Williamson. “Furthermore, the compelling preclinical data demonstrating efficacy and safety of the myxoma platform across a broad range of solid and liquid tumors suggests that OncoMyx has the opportunity to make significant breakthroughs in cancer therapy.”

Prior to joining OncoMyx, Mr. Williamson was the Chief Executive Officer of BioTheryX, a protein degradation therapeutics company, where he raised a $100 million crossover round and positioned the company for an initial public offering. Prior to joining BioTheryX, he served as Chief Executive Officer of both PharmAkea (acquired by Galecto) and ATXCo (acquired by Blade Therapeutics), oncology and fibrosis drug development companies financed through a partnership with Celgene. Prior to those companies, Mr. Williamson was Chief Executive Officer of Arriva Pharmaceuticals, President and Chief Operating Officer of Eos Biotechnology (acquired by Protein Design Labs), and Chief Operating Officer of DoubleTwist (acquired in part by Merck and Hitachi). Notably, Mr. Williamson served as an early Director of Pharmasset, where he helped finance, grow, and advance the company into the public markets and through its acquisition by Gilead in 2011 for $11 billion.

About OncoMyx’s Myxoma Immunotherapy Platform

OncoMyx’s multi-armed myxoma virus delivers multiple antitumor immunomodulatory proteins that target critical points in the cancer immunity cycle to modulate the tumor microenvironment and stimulate a robust anti-tumor response. Myxoma is a natural oncolytic virus, selectively infecting and killing a wide range of cancer cell types. It is also inherently highly immuno-interactive, and as a large dsDNA poxvirus, can be engineered to express multiple payloads to treat cancer. Because myxoma is not pathogenic to humans, there is no pre-existing immunity, making it highly amenable to intravenous and repeat dosing.

About OncoMyx Therapeutics

OncoMyx Therapeutics is advancing multi-armed, systemic immunotherapies with the potential to be broadly effective in treating solid tumors and heme cancers. Successful immuno-oncology cancer treatment generally requires combination therapy, and OncoMyx’s myxoma platform is designed to deliver multiple cancer-killing payloads in one therapeutic and orchestrate an immune response capable of treating a wide range of cancers. OncoMyx has assembled a top immuno-oncology team to develop next generation immunotherapies that can have the greatest therapeutic benefit for more cancer patients. The company’s myxoma virus platform is poised to be a best-in-class oncolytic virus approach and was developed based on breakthrough research from Dr. Grant McFadden’s lab that was exclusively licensed from Arizona State University.

Media Contact: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com , +1.858.344.8091

enGene Inc., a clinical-stage biotechnology company pioneering novel non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, today announced positive results from its LEGEND study, a first-in-human Phase 1/2 clinical trial of EG-70 for the treatment of high-grade Non-Muscle Invasive Bladder Cancer (NMIBC) in patients with carcinoma in situ (CIS) that are BCG-unresponsive.

For over 30 years, the standard treatment for NMIBC has been BCG immunotherapy. However, the 60% disease recurrence and progression rates associated with BCG treatment have created an urgent unmet medical need for NMIBC patients who are left with very few options. Ultimately, the majority of NMIBC patients that do not respond to BCG will undergo radical cystectomy, a procedure in which the bladder is removed concurrently with other surrounding organs.

The results from LEGEND study to-date have shown that enGene’s novel intravesical monotherapy, EG-70, is safe and well tolerated, with encouraging clinical efficacy in high-grade NMIBC patients with CIS in whom BCG has failed. Of the six patients that have reached the 3-month efficacy assessment, five have achieved complete response (CR). This marks an 83% CR rate that is trending best-in-class for an intravesical monotherapy at the end of the first treatment cycle.

“The responses observed with EG-70 are an important step towards NMIBC patients avoiding radical cystectomy,” said Dr. Gary Steinberg, Professor and Director at the Perlmutter Cancer Center and Department of Urology Goldstein Urology Bladder Cancer Program of NYU Langone Health, and lead Principal Investigator for the LEGEND study. “If similar results are observed as the study progresses, I am confident that this novel intravesical monotherapy will make a meaningful impact in the lives of patients with high risk NMIBC.”

“We are thrilled to announce the safety and clinical efficacy of EG-70 in patients with BCG-unresponsive NMIBC who are facing bladder removal as an alternative,” said Jason Hanson, Chief Executive Officer at enGene. “EG-70 was designed ab initio as an intravesical monotherapy that would slot directly into current medical practice to provide ease-of-use and increased access to patients. With the initial results providing a clear best-in-class trajectory, we are confident that EG-70 will be the organ-sparing solution that is a game-changer for patients and physicians.”

Summary of Clinical Results

• The analysis reported that 83% of patients evaluable for efficacy have achieved CR (N=6) at 3-months
• There have been no DLTs or SAEs reported to date
• AEs were limited to transient Grade 1 and Grade 2 Aes such as intermittent pain when urinating, urinary tract pain, bilateral serous otitis, increased nocturia, restlessness, and low back pain

The open label trial has a primary endpoint of safety and tolerability and a key secondary endpoint of CR rate at 3-months. With these initial data, the LEGEND study is slated to successfully meet both primary and secondary endpoints.

About enGene’s DDX platform – EG-70
Based on enGene’s DDX platform, EG-70 is a novel 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.

About the LEGEND 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. For additional information about the LEGEND study, please visit thelegendstudy.com.

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

Congruence Therapeutics, a biotechnology company working at the interface of computational and experimental drug discovery to design novel small molecules for diseases of protein misfolding, announced today the closing of a US$50 million, tranched, series A financing. The financing was led by Amplitude Ventures and Fonds de solidarité FTQ, with participation from Lumira Ventures, Investissement Quebec, OrbiMed Advisors, Driehaus Capital Management, and others.

“Our industry faces a watershed moment where the application of novel computational tools, including machine learning, is poised to disrupt traditional drug discovery,” commented Dr. Clarissa Desjardins. “Our proprietary computational platform, Revenir™, has already demonstrated its ability to uncover novel biophysical features of certain proteins that underpin disease. This financing will allow us to build out a world-class team of ‘drug hunters’ to efficiently design novel small molecules for rare diseases of high unmet medical need, and progress them toward and into the clinic. We are grateful for the strong commitment provided by our syndicate of investors.”

“We are delighted to back Clarissa and the Congruence team as we see the potential of computational approaches to design better drugs faster,” said Nancy Harrison, Venture Partner at Amplitude Ventures.

David Bonita, MD, General Partner of OrbiMed Advisors commented, “We are pleased to support this experienced team and their unique computational tools toward the goal of developing novel, next-generation pharmacological stabilizers, a well validated and commercially successful class of drugs for rare diseases.”

The cornerstone of the Congruence strategy is its proprietary computational platform, Revenir™, a tool for the rational design of stabilizers that circumvents the target validation, protein purification, high throughput screening and hit triage stages. This purpose-built technology uses mathematical modeling, physics, and machine learning to characterize the biophysical defects of misfolded proteins that cause disease, then designs compounds to rescue the mutated proteins by correcting these defects in silico. Congruence is currently deploying Revenir™ in indications with high unmet medical need. At the same time, the Company is building a proprietary database containing the biophysical properties of mutant proteins, which can be used to develop stabilizers for diseases caused by protein families outside of the Company’s current focus.

Congruence Therapeutics was founded in 2021 by Clarissa Desjardins, Ph.D., previously the founder and chief executive officer of Clementia Pharmaceuticals, a company developing therapies for rare pediatric bone diseases and sold to Ipsen in early 2019 for US$1.3 billion.  Clementia’s lead product, Sohonos™ (palovarotene), was recently approved in Canada and is under review at the FDA as the first treatment for Fibrodysplasia Ossificans Progressiva, a debilitating and progressive rare bone disorder.  At Congruence, Dr. Desjardins has put into place a team of ‘drug hunters’ with domain experience in rare disease strategy and clinical development, computational chemistry, medicinal chemistry, and business development.

Concurrent with the financing, Kenneth J. Valenzano, Ph.D. has joined the company as Chief Scientific Officer. Dr. Valenzano most recently served as Senior Vice President of Drug Discovery for Amicus Therapeutics, a leading company historically focused on pharmacological chaperones to treat human genetic diseases. Dr. Valenzano participated in the discovery and development of several small molecule chaperones including Galafold™ (migalastat), the first and only orally-available, small molecule treatment for Fabry’s Disease approved in Europe and in the US in 2018.

About Congruence Therapeutics
Congruence Therapeutics is a biotechnology company working at the interface of computational and experimental drug discovery to design novel small molecules for diseases of protein misfolding.  Using structural bioinformatics, computational chemistry, and machine learning, the Company is deploying an in silico platform that enables the design of new pharmacological stabilizers, a validated class of small molecules, at an unprecedented speed and scale.

For more information, please visit www.congruencetx.com.

Company Contact
Charles Grubsztajn
Chief Operating Officer
cgrubsztajn@congruencetx.com

Media Contact
David Rosen
Argot Partners
David.rosen@argotpartners.com 
212-600-1902

SOURCE Congruence Therapeutics

XyloCor Therapeutics, a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced that it has appointed Elizabeth Tarka, M.D.  as Chief Medical Officer and A. Brian Davis as Chief Financial Officer. These experienced pharmaceutical industry executives will enhance the company’s clinical development, operational, and financial capabilities and drive its ongoing growth. “I am delighted to welcome Liz and Brian to the leadership team at XyloCor,” said Al Gianchetti, President and Chief Executive Officer. “Liz is a proven R&D leader who brings a strong track record managing late-stage clinical development programs with particular expertise in cardiovascular medicine. Brian will leverage his extensive management and finance experience in both private and public biotech companies to accelerate XyloCor’s strategic and corporate objectives. Their collective experience will drive XyloCor toward our objectives as we focus on advancing our pipeline of transformative gene therapies intended to improve the lives of people with cardiovascular disease.”

Dr. Tarka is a cardiologist with over 20 years of experience in the pharmaceutical and biotechnology industry.  She has dedicated her career to the development of innovative therapies that improve human health.  Dr. Tarka’s experience includes leadership roles across all phases of late-stage clinical development and a track record of effectively partnering with stakeholders to enable the successful execution of clinical trials. She joins the company from Idera Pharmaceuticals where she served as CMO. Before that, Dr. Tarka was Vice President, Clinical Development at Complexa, Inc., a clinical stage biopharmaceutical company focused on life-threatening fibrosis and inflammatory diseases. Earlier in her career, she served as Clinical Program Leader for Xarelto^® (rivaroxaban) at Janssen Pharmaceuticals, where she was responsible for the design, implementation, and medical oversight for large multinational trials. Prior to her tenure at Janssen, Dr. Tarka worked at GlaxoSmithKline in the Metabolic Pathways and Cardiovascular Therapeutic Area. She has been on the faculty and had numerous major teaching and clinical responsibilities at the University of Pennsylvania and affiliated hospitals. She is trained in Cardiology and Internal Medicine and has published in a number of peer-reviewed journals. Dr. Tarka earned a BA in Biochemistry and an MD from the University of Pennsylvania where she also completed her residency and fellowship training.

Mr. Davis joins XyloCor with a proven background as a seasoned financial executive, including over 15 years of experience as a CFO for publicly traded, commercial- and clinical-stage biopharmaceutical companies, and nearly 30 years as a financial professional in the life sciences industry. He has extensive expertise in fundraising, financial strategy, negotiating strategic transactions involving acquisition and disposition of commercial and clinical-stage assets, shareholder relations, and SEC accounting, reporting, and compliance.  Mr. Davis has raised over $600 million in public and private equity financings, including leading an initial public offering, and nearly $200 million in debt financings. Most recently, he was CFO at Verrica Pharmaceuticals, where he held managerial responsibility for executing equity and debt financings, analyst and shareholder relations, financial aspects of commercial launch preparation, business development, finance, accounting, tax, and treasury. Before that, Mr. Davis had similar duties as CFO at Strongbridge Biopharma plc, Tengion, Inc., and Neose Technologies, Inc. Mr. Davis is a Certified Public Accountant. He earned an MBA from The Wharton School, University of Pennsylvania and an undergraduate degree in Accounting from Trenton State College.

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 currently being investigated in a Phase 2 clinical trial 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.

Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported that the company has received approval from Health Canada to test its monoclonal antibody candidate, designated EB05, as a rescue therapy for critically ill patients in the Phase 3 part of a Phase 2/3 clinical study.

Edesa believes that EB05 regulates the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure that accounts for ~10% of all ICU admissions (pre-pandemic) and is the leading cause of death among COVID-19 patients. Approval of the company’s Phase 3 study design follows favorable Phase 2 results, which demonstrated compelling preliminary evidence of EB05’s ability to reduce mortality in the sickest patients. Among the results, critically ill hospitalized COVID-19 patients given EB05 plus standard of care treatment had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

“Health Canada’s approval represents a significant milestone in our goal of demonstrating the broad potential utility of EB05 in a critical care setting,” said Par Nijhawan, MD, Chief Executive Officer of Edesa. He noted that there’s an urgent need for therapeutics that are agnostic to SARS-CoV2 variants.

“The growing number of COVID variants – and the inherent limits of vaccines and anti-viral drugs – have highlighted the importance of agnostic therapies, like EB05, that target the patient’s immune response rather than the virus. While the Phase 3 study is designed to confirm the Phase 2 results, the preliminary data shows that EB05 has already saved lives. Perhaps just as important, this innovative technology is providing greater confidence that COVID can be well managed one day, like other endemic diseases,” said Dr. Nijhawan.

Edesa reported that the Phase 3 double-blind study is designed to assess the efficacy and safety of EB05 among critically ill COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation plus organ support (IMV+), defined as Level 7 on the World Health Organization’s COVID-19 Severity Scale. The primary endpoint for the Level 7 patients will be 28-day mortality. Ventilator free days and 60-day mortality will also be measured among other secondary endpoints. The amended trial protocol design calls for approximately 315 evaluable subjects. The company has opened patient enrollment under the amended protocol.

Health Canada reviewed Edesa’s study design amendment and approved it by issuing a “Notice of Authorization,” which allows the company to proceed with its planned study design. Under the amended protocol, Edesa also has the option to complete a separate study group of less severe patients receiving only invasive mechanical ventilation (WHO COVID-19 Severity Scale Level 6), which would be evaluated independently.

Edesa has filed similar protocol amendments with the U.S. Food and Drug Administration (FDA) as well as other jurisdictions. In the U.S., the company is currently in discussions with the FDA on the design of the final Phase 3 protocol.

About EB05
EB05 is a monoclonal antibody designed to inhibit toll-like receptor 4 (TLR4) signaling – an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. In September 2021, the company reported that an independent monitoring board for the Phase 2/3 study concluded that “a clinically important efficacy signal” was detected and that the Phase 2 study “met its objective.” The monitoring board further recommended continuation of the study into a Phase 3 confirmatory trial. Edesa’s Phase 2 study of EB05 in hospitalized COVID-19 patients was funded in part by a C$14 million grant from the Canadian Government’s Strategic Innovation Fund.

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

About Edesa Biotech, Inc.
Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. 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. Connect with us on Twitter and LinkedIn.

Edesa Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s belief that EB05 could regulate the overactive and dysfunctional immune response associated with ARDS; the company’s belief in the broad potential life-saving impact of its EB05 monoclonal antibody candidate; the company’s belief that there’s a critical need for therapeutics that are agnostic to SARS-CoV2 variants; and the company’s timing and plans regarding its clinical studies in general. 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

LQT Therapeutics, Inc. (“LQTT”) is pleased to announce a collaboration with the laboratory of Dr. Donald McDonnell of Duke University School of Medicine to evaluate LQTT SGK1 inhibitors as potential treatment for patients with resistant prostate and breast cancer. Despite the approval of recent treatments for patients with these cancer types, resistance often emerges, and new treatments are needed. Recently, numerous scientists have produced evidence of SGK1’s role in the resistance of various cancers to existing therapies, and Dr. McDonnell’s laboratory has extensive experience in understanding this specific role. “The research in our group is focused on the development and application of mechanism-based approaches to identify novel therapeutics for use in the treatment and prevention of hormonally responsive cancers. We are interested in estrogen and androgen receptors (AR) as therapeutic targets in breast and prostate cancers and in defining how these receptors influence the pathogenesis of these diseases. The utility of targeting processes downstream of AR, such as SGK1 inhibition, could provide an alternate approach to therapy. In our laboratories we have demonstrated SGK1 inhibition blocks the effect of androgens in known cancer cell proliferation assays, and we believe SGK1 inhibition is a promising target in treatment resistant cancer. We are excited to evaluate LQTT’s platform of SGK1 inhibitors in our models of treatment resistant cancers,” said Dr. Donald McDonnell. Research at LQTT has validated the effects of SGK1 inhibition on cell proliferation pathways in prostate and colorectal cancers. Often difficult to treat cancers may be resistant from the start, or develop resistance during treatment with existing therapies through a variety of mechanisms. The recent approval of novel targeted therapies against cancer also generated additional pathways of resistance, and new opportunities to develop precision treatments to address this resistance. Additional roles for the activation of SGK1 in various cancer pathways continue to be discovered, and LQTT intends to explore these pathways and continues to advance a series of compounds with promise to address the treatment challenges of these resistant cancers. “We are looking forward to working with Dr. McDonnell and his team to further develop SGK1 inhibitors in different models of resistant cancers” said Dr. Eric Campeau, Vice President of Translational Research at LQT Therapeutics, Inc. “Dr. McDonnell and his scientific team have demonstrated the role of SGK1 in promoting tumor growth and overcoming resistance to anticancer treatments. We are hopeful SGK1 inhibition will prevent cancer progression in animal models of these resistant cancers. Our collaboration will aim to identify the optimal SGK1 inhibition profile required for anti-tumor activity, as well as the patient population that could most benefit from such therapy.”

About LQT Therapeutics, Inc.
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, Inc. was founded by world-class experts in cardiovascular disease, cardiac muscle biology and drug development. For more information, please visit www.lqttrx.com

Media Inquiries:
Daphne Doucet | daphne@lqttrx.com | +1 (514) 973-0915

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced nomination of the first targeted alpha therapy (TAT) candidate under the Company’s collaboration agreement with AstraZeneca (LSE/STO/Nasdaq: AZN). Both companies will jointly develop through a Phase 1 study the novel TAT which utilizes Fusion’s Fast-Clear™ linker technology to radiolabel an AstraZeneca-owned bispecific antibody with the alpha-emitting isotope, actinium-225.

“Fusion is at the forefront developing a new wave of cancer therapies using alpha-emitting medical isotopes and various targeting vehicles,” said John Valliant, Ph.D. “One of the pillars of our platform is to create next-generation immunoconjugates, and we are excited to be working with AstraZeneca to pursue a novel radioimmunoconjugate for oncology. We had strong alignment among our joint development committee to move this novel TAT forward into a planned Phase 1 study and we look forward to sharing more information as we approach the investigational new drug application (IND) filing.”

Under the terms of the previously announced collaboration agreement, Fusion will be operationally responsible for preclinical development through first-in-human studies, while AstraZeneca will be responsible for subsequent clinical development. The companies will share costs equally through clinical development. IND enabling studies are ongoing.

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 Response Inhibitors (DDRis) and Immuno-Oncology (IO) agents.

About AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com.

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 the novel TAT to be developed with AstraZeneca and the potential for it to move into Phase 1 clinical studies. 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, research, development or clinical activities; 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; 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, 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.

SOURCE Fusion Pharmaceuticals Inc.

Honor Recognizes Companies Advancing Innovative Solutions to Improve Women’s Health and Safety in Emerging Markets

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 that the World Bank Group and the Consumer Technology Association (CTA) have named it one of the winners of The Global Women’s HealthTech Awards. These awards recognize innovative companies that leverage technology to improve women’s health and safety in emerging markets. Antiva was one of the winners selected by a panel of industry experts from entries submitted by over 70 companies from 35 countries. Antiva’s lead development candidate, ABI-2280, is being developed 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 recently dosed the first subject in its Phase 1 clinical trial of ABI-2280 and expects data from the study to be available in mid-2022. “We are honored to be recognized by the World Bank Group and CTA and offer our congratulations to all of the other winners who are working to improve women’s health around the world. At Antiva, we have made women’s and global health a central tenet of our mission and our work with ABI-2280 is a perfect example of our efforts in this area,” said Gail Maderis, president and chief executive officer of Antiva. “To this end, we are excited to have recently advanced ABI-2280 into clinical development. We believe that this topical therapy, together with innovative screening and diagnostic tools, can offer a ‘see and treat’ solution to prevent cervical cancer, a disease which kills more than 300,000 women annually.”

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

Closing the gap between industry and academia to place patients directly at the center of research efforts. 

LQT Therapeutics, a privately-held biopharmaceutical company advancing novel SGK1 kinase therapeutics, today announced that the project, “SILENCE-LQTS: SGK1 inhibition as a novel therapeutic approach in Long QT Syndrome” was selected for funding by the European Joint Program on Rare Diseases (EJP RD). The EJP RD is a collaboration of over 130 institutions from 35 countries, working together to create a comprehensive, sustainable ecosystem between research, care, and medical innovation. 

Congenital Long QT Syndrome (LQTS) is a rare inherited disorder associated with life- threatening arrhythmias and sudden cardiac death (SCD) in relatively young and otherwise healthy individuals. LQTS has a heterogeneous genetic basis, usually impacting one of 3 key cardiac ion channels caused by mutations in distinct genes. Current symptom-directed therapies aimed at reducing arrhythmia triggering events, including lifestyle changes, beta blockade, and left cardiac sympathetic denervation, only partly prevent arrhythmic events, and syncope and SCD still occurs in a substantial number of LQTS patients. 

Within SILENCE-LQTS, the EJP RD consortium will investigate a novel, mechanism- targeted therapy, comprising pharmacological inhibition of the serum and glucocorticoid regulated kinase-1 (SGK1). In contrast to current symptom-directed therapies, this novel approach is designed to correct the pro-arrhythmic alterations in ion channel homeostasis caused by the underlying genetic defect. Efficacy of a SGK1 inhibitor, developed by LQT Therapeutics, will be systematically tested to establish the anti-arrhythmic potential of SGK1 inhibition, paving the way for future clinical application aimed at preventing symptoms and SCD in LQTS. 

“Because current symptom-directed therapies aimed at reducing arrhythmia triggering events, including lifestyle changes, beta blockade, and left cardiac sympathetic denervation, only partly prevent (lethal) arrhythmic events, there remains a crucial unmet need for novel, more efficacious, mechanism-driven therapies,” said Arthur Wilde, MD, PhD, Amsterdam University Medical Centers and EJP RD Consortium Member. 

LQT Therapeutics has shown that SGK1 inhibition in cardiomyocytes from patients with different LQT genetic mutations leads to shortening of the action potential duration. If this behavior translates in vivo, there is the potential to change the lives of patients with Congenital Long QT Syndrome, many of whom rely on medications that are not fully effective and have unpleasant side effects or implanted cardiac defibrillators. 

“This award represents a significant milestone for LQT Therapeutics as we advance our platform of SGK1 inhibitors,” said Debra Odink, PhD, Chief Development Officer of LQT Therapeutics. “We are grateful to the EJP RD for this award and the opportunity of working with the consortium. Advancing therapeutics for people with Long QT Syndrome is a focus of LQT Therapeutics and we aim to restore normal life to those that live in fear of developing a potentially life-threatening arrhythmia.” 

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 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, Inc. was founded by world-class experts in cardiovascular disease, cardiac muscle biology and drug development. For more information, please visit www.lqttrx.com 

About the EJP RD 

The European Joint Program on Rare Diseases (EJP RD) is a program aiming to create an effective rare diseases research ecosystem for progress, innovation and for the benefit of everyone with a rare disease. We support rare diseases stakeholders by funding research, bringing together data resources and tools, providing dedicated training courses, and translating high quality research into effective treatments. Consortium members include Arthur Wilde (Amsterdam University Medical Center), Lia Crotti (Istituto Auxologico Italiano), Katja Odening (University of Bern) and Lior Gepstein (Technion – Israel Institute of Technology), along with the patient advocacy organization, Hart4Onderzoek (Hart4Research) of the Netherlands. 

—

LQT Therapeutics Inc.

500, boulevard Cartier Ouest

Laval (Québec)  H7V 5B7

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has granted approval for an amendment to the company’s PROACTIVE-HF study, a pivotal Investigational Device Exemption (IDE) trial investigating the Cordella Pulmonary Artery (PA) Pressure Sensor¹, shifting the design from a randomized control study to a single-arm study. Following the 2021 update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment and the recently presented GUIDE-HF data, the FDA’s decision underscores the clinical benefits of PA pressure-guided HF management for New York Heart Association (NYHA) class III heart failure patients^2,3.  The new PROACTIVE-HF trial design ensures the over 100 previously enrolled patients have immediate access to the proven clinical benefits of PA pressure-guided therapy and expands the study to include clinical sites across Europe, as well as the U.S. The company is currently implementing the updated PROACTIVE-HF study design at trial sites worldwide.

“The FDA’s decision to approve the amended study design further validates what we are seeing in clinical practice. PA pressure-guided heart failure management is quickly becoming standard of care for NYHA class III patients based on the growing body of evidence supporting this approach,” commented Dr. Liviu Klein, Section Chief, Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension and Heart Transplant at UCSF and National Principal Investigator of the PROACTIVE-HF trial. “Understanding changes in PA pressure data is key to properly implementing guideline directed medical therapy and keeping these patients out of the hospital. The Cordella HF System and Sensor offers the next gen technology in PA pressure sensing and will play a critical part in how heart failure patients are managed moving forward.” 

The single-arm study design maintains similar safety and efficacy endpoints as the original study design, with the primary efficacy endpoint designed to demonstrate low rates of all-cause mortality and HF hospitalizations in the high-risk NYHA class III patient cohort. Under the updated study design, the PROACTIVE-HF trial will enroll over 400 NYHA class III patients at more than 100 sites worldwide. The trial is expected to complete enrollment in the second half of this year.

“The FDA’s decision is great news for our PROACTIVE-HF study patients – they now have immediate access to technology that is designed to keep them healthier and out of the hospital. Furthermore, it is an important acknowledgement for the therapeutic category and the benefits that PA pressure-guided heart failure management enables,” stated Harry Rowland, CEO of Endotronix. “Our team and clinical partners have been energized by the announcement and it obviously has a significant impact on our ability to bring the Cordella Sensor to market sooner in the U.S. and Europe.”

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

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

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

1. CAUTION: Investigational device. Limited by Federal law to investigational use.
2. Maddox TM, Januzzi JL et al. 2021 J Am Coll Cardiol. 2021 Feb, 77 (6) 772-810.
3. Lindenfeld J, Zile MR, et al. Lancet. 2021 Sept 11; 398 (10304):991-1001.

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

SOURCE Endotronix, Inc.

Specific Biologics Inc. (“Specific”) today announced that it has closed its first institutional financing, led by Lumira Ventures and adMare BioInnovations which have recently established an innovative partnership to build Canadian life sciences companies. Gene editing holds the potential to cure a wide range of genetic diseases by altering DNA in the genome inside cells – but today’s gene editors have limitations. To better realize the significant opportunity of this therapeutic approach, and allow for its application to new therapeutic areas, Specific Biologics has developed the unique next-generation Dualase™ gene editing platform which can more accurately alter DNA sequences by cutting DNA in two spots as a single molecule. Specific has demonstrated the benefit of this two-site mechanism in proof-of-concept studies in disease-relevant models.

“Based on our early work with Dualase™, we believe it will have broad utility across a number of diseases with high unmet need,” said Dr. Brent Stead, CEO of Specific Biologics Inc. “This investment by Lumira and adMare, two recognized leaders in life sciences, will help accelerate the advancement of our promising platform, and a pipeline of differentiated Dualase™-based gene editing therapeutics in a diverse range of indications.”

“Current gene editing technologies are constrained by low on-target editing efficiency and high unintended off-target effects. Data suggest that Dualase™ has the potential to overcome these well-known challenges in relevant therapeutic indications,” noted Dr. Daniel Hetu, Managing Director at Lumira Ventures. “Built on the work of Dr. David Edgell at Western University’s Schulich School of Medicine & Dentistry, Specific Biologics represents another example of how Canadian health science innovators are at the leading edge of treatment modalities,” added Nikhil Thatte, Principal at Lumira Ventures. “We are excited to work alongside adMare and the Specific team to grow the company and bring transformative therapies to patients.”

“The investment in Specific Biologics stems from a new partnership between adMare and Lumira Ventures,” commented Dr. Frédéric Lemaître Auger, Managing Partner, Investments with adMare. “adMare builds life sciences companies by partnering with and investing in Canadian innovators and entrepreneurs. The partnership with Lumira recognizes the complementary nature of our organizations’ resources, expertise, and roles in the ecosystem, and has resulted in our firms aligning to co-identify, support, and advance opportunities of mutual interest in a range of development stages. By working together in this way, adMare and Lumira are committed to expanding our contribution to the growth of the industry, and to making Canada a global life sciences leader. The investment in Specific Biologics is a great example of how we are effectively doing that – helping scale a highly-promising young company founded around world-leading Canadian research.”

About Specific Biologics Inc.

Specific Biologics Inc. (“Specific”) is a venture-backed early-stage biotechnology company on a mission to develop novel gene editing technologies to treat diseases through precision gene editing. Our two-site Dualase™ platform gene editors cut DNA in a way that optimally exploits the cell’s naturally occurring DNA repair pathways. This enables two gene editing outcomes, precise DNA deletions to disrupt genes or increased repair to correct genes. Specific also develops lipid nanoparticles to deliver the gene editor to target cells and is developing a pipeline of Dualase™-based therapeutics in areas of high unmet medical need. To learn more, visit www.specificbiologics.com.

About Lumira Ventures

Lumira Ventures is a North American healthcare venture capital firm with decades of experience of investing in and helping to build transformative biomedical companies. We are a multi-stage investor that partners with mission-driven entrepreneurs and like-minded investors to build innovative healthcare companies. 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 patients worldwide. Lumira Ventures manages its activities from offices in Toronto, Montréal, Vancouver and Boston. For more information, please visit www.lumiraventures.com

About adMare BioInnovations

With a wealth of scientific discovery, Canada is primed to be a global leader in life sciences. To realize this potential, adMare uses its scientific and commercial expertise, specialized R&D infrastructure, and investment capital to build investable companies, robust ecosystems and industry-ready talent – and re-invests its returns back into the Canadian industry to ensure it is sustained for the long-term. adMare’s 25+ portfolio companies have attracted more than $1.4billion of investment, have a combined value of over $3 billion, and employ more than 900 Canadians. Its Innovation Centres are home to 35+ life sciences companies, contract research organizations, and specialized commercialization support organizations; and the adMare Academy has trained 500+ alumni – 95% of whom are now working to build the Canadian life sciences industry. For more information, please visit www.admarebio.com

Media Inquiries:
info@specificbiologics.com
Ph: 647-773-4591

SOURCE Specific Biologics Inc.

www.specificbiologics.com

Antios Therapeutics, Inc. (“Antios”) and Arbutus Biopharma Corporation (Nasdaq: ABUS) today announced that the first patient has been dosed in a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection. A single cohort in the ongoing Antios Phase 2a SAVE-1 (Sustained Anti-Viral Efficacy) clinical trial will evaluate a triple combination of Antios’ proprietary active site polymerase inhibitor nucleotide (ASPIN), ATI-2173, Arbutus’ proprietary GalNAc delivered RNAi therapeutic, AB-729, and tenofovir disoproxil fumarate (TDF), a nucleotide reverse transcriptase inhibitor.

The multi-center, double-blind, combination clinical trial plans to enroll 40 patients including a cohort of 10 patients with chronic HBV infection assigned 8:2 to active drugs (ATI-2173+AB-729) or matching placebos. The active drugs (ATI-2173+AB-729) or placebos will be administered in combination with 300 mg of tenofovir disoproxil fumarate. ATI-2173 and tenofovir disoproxil fumarate will be administered orally and by injections once daily for 90 days. AB-729 will be administered by subcutaneous injection at Day 28 and Day 90. Following this 90-day treatment period, patients will be followed-up for safety and sustained antiviral responses for six additional months.

“The need for a functional cure for HBV is clear. Current therapies only partially suppress HBV replication and require ongoing treatment, adding to patient burden,” said Douglas Mayers, M.D., Chief Medical Officer and Co-Founder of Antios. “By combining AB-729 with ATI-2173 and tenofovir disoproxil fumarate, we hope to reduce hepatitis B surface antigens and sustain HBV DNA suppression while off treatment.”

ATI-2173 is the only ASPIN in clinical development and pre-clinical data to date for ATI-2173, alone or combined with TDF, indicate the potential for sustained HBV DNA suppression off treatment, unique among approved nucleos(t)ides and investigational anti-HBV therapies.

Dr. Gaston Picchio, Chief Development Officer of Arbutus, commented, “In our common endeavor to find a cure for chronic HBV, we are eager to evaluate the combination of these two unique assets which we expect will allow us to further understand the potential benefits of such combination therapy for patients with chronic HBV.”

AB-729 is an RNAi therapeutic that inhibits viral replication and reduces all HBV antigens. In clinical trials to date, AB-729 has demonstrated positive safety and tolerability data as well as meaningful reductions in HBV surface antigen.

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 designed to be complementary to other approaches that also seek to achieve a functional cure. ATI-2173 is currently in Phase 2a 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 AB-729

AB-729 is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens, including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. AB-729 targets hepatocytes using Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. Clinical data generated thus far has shown single- and multi-doses of AB-729 to be generally safe and well-tolerated while providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. AB-729 is currently in a Phase 2a clinical trial in combination with Peg-IFNα-2a and nucleos(t)ide analog (“NA”) therapy.

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 up to 300 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 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. Antios recently entered into an agreement with IRBM to acquire a novel series of fourth-generation capsid assembly modulators (CAMs) to further expand Antios’ portfolio of differentiated molecules in the HBV space. HBV is 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.

About Arbutus

Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of assets with different modes of action to provide a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple product candidates with distinct mechanisms of action that suppress viral replication, reduce surface antigen and reawaken the immune system. Arbutus believes this three-prong approach is key to transforming the treatment and developing a potential cure for chronic HBV infection. Arbutus’ HBV product pipeline includes RNA interference (RNAi) therapeutics, oral capsid inhibitors, oral compounds that inhibit PD-L1 and oral HBV RNA destabilizers. In addition, Arbutus has an ongoing drug discovery and development program directed to identifying orally active agents for treating coronaviruses (including COVID-19). For more information, visit www.arbutusbio.com.

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 future development plans for our product candidates, including the expected trial design of the triple combination trial with Antios; our expectations regarding the results of the triple combination trial with Antios; and the potential for our product candidates to achieve success in clinical trials.

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: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, may never be initiated or completed, or may not generate results that warrant future development of the tested product candidate; Arbutus or Antios may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt Arbutus’ or its partners’ 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.

For More Information:

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

OpSens Inc. (“OpSens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF), a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, today announced that it has filed a 510(k) submission with the U.S. Food & Drug Administration (“FDA”) for regulatory clearance of its new guidewire (“SavvyWire”) for transcatheter aortic valve replacement, or TAVR procedures. OpSens has also filed for approval with Health Canada.

“The FDA submission is a key milestone for OpSens, in introducing our innovative product to the cardiovascular market. The SavvyWire has been designed and developed to improve the workflow in transcatheter aortic valve replacement,” commented Louis Laflamme, President and Chief Executive Officer of OpSens. “The introduction of a novel and advanced guidewire that has the ability to both deliver a valvular prosthesis while allowing continuous hemodynamic pressure measurement during the procedure is considered to be a significant benefit to the medical community, especially given the rapid growth in TAVR procedures. We look forward to the agencies review of our application and will continue to prepare our organization for an anticipated approval in late summer or fall of 2022.”

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.

About OpSens Inc. (www.OpSens.com or www.OpSensmedical.com)

OpSens focuses mainly in interventional cardiology. The Company offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of over 150,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.

OpSens is also involved in industrial activities in developing, manufacturing, and installing innovative fiber optic sensing solutions for critical applications.

Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, and achievements of OpSens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.

Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.

SOURCE OPSENS Inc.

For further information:

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

Robin Villeneuve, CPA, CA Chief Financial Officer, 418.781.0333

OncoMyx Therapeutics, a privately-held immuno-oncology platform company, today announced the closing of a $50 million Series B financing, co-led by Lumira Ventures and B Capital Group with participation from LYZZ Capital and all Series A investors: Boehringer Ingelheim Venture Fund, Delos Capital, Xeraya Capital, Korea Investment Partners, City Hill Ventures, and Madison Partners. In conjunction with the financing, Benjamin (Beni) Rovinski, Ph.D., Managing Director of Lumira Ventures and Widya Mulyasasmita, Ph.D., Senior Principal, Healthcare at B Capital Group will join the company’s Board of Directors. The proceeds of the financing will support the further development of OncoMyx’s pipeline of multi-armed myxoma immunotherapies for the treatment of solid tumors and hematological malignances and the advancement of the company’s lead candidate into clinical trials.

OncoMyx has leveraged myxoma’s unique qualities to build an immunotherapy platform to deliver multiple cancer killing payloads in one therapeutic. Myxoma is a natural oncolytic virus, selectively infecting and killing a wide range of cancer cell types. It is also inherently highly immuno-interactive, and as a large dsDNA poxvirus, is engineerable to express multiple payloads. OncoMyx’s multi-armed myxoma virus delivers different antitumor immunomodulatory proteins that hit critical points in the cancer immunity cycle to modulate the tumor microenvironment and stimulate a robust anti-tumor response. Because myxoma is not pathogenic to humans, it does not have to overcome pre-existing immunity and is highly amenable to IV and repeat dosing with a longer dosing window.

“OncoMyx builds on more than three decades of research into the myxoma virus, brings together the top team with experience developing targeted cancer treatments, immunotherapies, and virotherapies, and is fueled by a commitment to addressing unmet medical needs in patients with cancer,” said Steve Potts, Ph.D., MBA, cofounder and CEO of OncoMyx. “The power of our myxoma platform is the potential to systemically deliver broad and selective targeting of cancer cells combined with robust activation of the cancer immunity cycle in a single therapeutic. With this financing, we plan to advance our lead multi-armed myxoma immunotherapy into clinical trials to demonstrate initial safety and efficacy of intravenous dosing.”

“I have long been interested and was previously involved in the development and use of modified, recombinant viruses as immunotherapeutic agents. Oncolytic viruses in particular have shown clinical promise but a significant challenge has been the inability to engineer a safe and versatile oncolytic virus platform that is not restricted to local intratumoral delivery,“ said Dr. Rovinski. “The use of myxoma virus, which is not pathogenic to humans and can accommodate several insertions of heterologous therapeutic agents, as the backbone of OncoMyx’s immunotherapy platform, represents a uniquely differentiated feature that has the potential to overcome the well-known historical challenge of effectively delivering oncolytic viruses systemically for optimal dosing. We believe that OncoMyx’s myxoma-based oncolytic viruses may become best-in-class components of novel immunotherapeutic regimens, and we look forward to supporting the world class team at OncoMyx to bring these therapies to patients in need.”

“We always seek to invest in companies with visionary founders and world-changing technology, and we saw the unmatched potential of OncoMyx’s myxoma platform to make a significant breakthrough in cancer immunotherapy by delivering multiple immune-activating and anti-tumor agents in one off-the-shelf package. We are impressed with the extensive preclinical data OncoMyx has generated demonstrating efficacy and safety of the myxoma platform across a broad range of cancers, from hematological malignancies to solid tumors,” said Dr. Mulyasasmita. “OncoMyx has attracted an exceptionally experienced and talented team who are as committed as the founders about building the next great immuno-oncology company that delivers lifesaving medicines for many difficult to treat cancers. We couldn’t be more thrilled and honored to support their mission.”

OncoMyx has presented preclinical safety and efficacy data at major scientific conferences demonstrating their myxoma immunotherapies stimulate anti-tumor immunity and produce anti-tumor efficacy in a wide range of models following IV or intratumoral administration. The data, along with previously published studies, support the advancement of these therapies into clinical development as a monotherapy and in combination with many cancer therapeutics and immunotherapies, including checkpoint inhibitors and chemotherapies. The company plans to advance its lead candidate into clinical trials next year to generate safety and efficacy data for IV dosing.

About OncoMyx Therapeutics
OncoMyx Therapeutics is advancing multi-armed, systemic immunotherapies with the potential to be broadly effective in treating solid tumors and heme cancers. Successful immuno-oncology cancer treatment generally requires combination therapy, and OncoMyx’s myxoma platform is designed to deliver multiple cancer-killing payloads in one therapeutic and orchestrate an immune response capable of treating a wide range of cancers. OncoMyx has assembled the top immuno-oncology team to develop next generation immunotherapies that can have the greatest therapeutic benefit for more cancer patients. The company’s myxoma virus platform is poised to be a best-in-class oncolytic virus approach and was developed based on breakthrough research from Dr. Grant McFadden’s lab that was exclusively licensed from Arizona State University. For more information, please visit www.oncomyx.com and connect with the company on LinkedIn and Twitter.

www.oncomyx.com

Maryland-based biotech company Deka Biosciences (“Deka”) today announced that it has successfully closed a USD 20 Million Series A financing with a syndicate of life science investors led by Leaps by Bayer, the impact investment arm of Bayer AG, and new investor Lumira Ventures. Additional investors include O-Bio (Echo Investment Capital), Viva BioInnovator, and Alexandria Venture Investments.

Novel cytokine-based therapies have the potential to provide patients with innovative curative treatment options for cancer, autoimmune diseases, and many types of infectious diseases. Understanding the known function of each cytokine, Deka has developed Diakines™ – intentionally engineered therapeutic proteins that are designed to deliver clinically validated cytokines, coupled in combination in the Diakine™ structure, to diseased tissue. Deka has also combined this therapeutic platform with companion diagnostic assays that ensure delivery of each Diakine™ to patients that will benefit the most.

In Deka’s Diakines™, the scaffold platform is derived from a human antibody fragment, called a single-chain variable fragment, that uniquely functions both as a stabilizing, half-life extension technology and a targeting vector to deliver the cytokine(s) function to specific cell types or the microenvironment of affected tissues. Through stabilization and improved manufacturing techniques, the Diakine™ scaffold increases production yields and reduces manufacturing costs, and the unique structure enhances the specific functions of each cytokine, unlike most other half-life extending technologies. The company has demonstrated positive responses in preclinical studies, in both cancer and inflammatory disease models. Through extensive investigation, Deka has found that not all people respond to the same cytokine in the same way. Deka has therefore developed assays that evaluate each patients’ response to each cytokine pair and found genetic signatures that are uniquely associated with response to each Diakine™. Deka will evaluate this genetic signature in future clinical trials to ensure that each patient is matched with their best Diakine™. The team at Deka is committed to developing Diakines™ that can treat every patient.

“This investment by our multi-national, top-tier syndicate enables our first step in developing the Diakine™ platform,” said John Mumm, CEO and founder of Deka Biosciences. “We are proud to join forces with our board of directors to bring these life-changing medicines to patients as quickly and effectively as possible. We share the vision to fundamentally change the nature of drug development and change the standard of healthcare through coupling our platform technology with predictive precision medicine. We are honored to have Leaps by Bayer as our lead investor as we share the goals to develop cures for patients through innovative science and precision medicine. We dare to leap as they do.”

“Leaps by Bayer aims to achieve life transforming breakthroughs for patients, this is why we invest in technologies of tomorrow already today,” said Juergen Eckhardt, MD, Head of Leaps by Bayer. “One of humankind’s biggest challenges and one of the big goals Leaps by Bayer is trying to solve is to prevent and cure cancer. We believe next-generation immunotherapies will play a pivotal role in addressing this challenge and Deka Biosciences’ cytokine therapy approach has the potential to change treatment-paradigms for cancer patients and for those suffering from auto-immune diseases.”

“Deka Biosciences has developed a unique and strongly differentiated platform to produce cytokines with therapeutically complementary functions that circumvent several challenges associated with naturally occurring and modified cytokines,” said Benjamin (Beni) Rovinski, PhD, Managing Director of Lumira Ventures. “At Lumira, our mission is to invest in companies at the forefront of biomedical innovation whose products have the potential to transform patient outcomes. It is gratifying to support Deka in pursuit of such a goal.”

“Deka has made impressive progress since its inception. We are excited to partner with Deka, and its Diakine™ platform, to provide best-in-class therapies to patients,” said Yi-Yen Chen, managing director at Echo Investment Capital’s O-Bio fund, a life science focused fund headquartered in Oklahoma City.

The investment will enable Deka to advance its research and talent acquisition and further expand development of its platform, in particular to file the Investigation New Drug (IND) application for the lead oncology program and advance the lead compound into Phase I clinical trials.

About Deka Biosciences
Deka is an early-stage biotech company focused on the development of novel cytokine therapies to treat cancer and inflammatory diseases such as Crohn’s, psoriasis, rheumatoid arthritis and sepsis. The company is led by serial entrepreneur John Mumm, who is backed by a team of experienced biopharma and CDMO innovators with expertise in drug discovery, product development, characterization and testing. Deka has developed disease specific Diakines™ that maximize patient benefits through improved pharmacokinetics / pharmacodynamics (PK/PD) function via targeted delivery of dual and complimentary cytokines to affected tissues or cells. Through the use of precision medicine, Deka’s vision is to maximize the impact of its Diakine™ therapeutic proteins by ensuring treatment of patients who will best benefit from and respond to our cytokine therapies. To learn more, visit www.dekabiosciences.com.

SOURCE Deka Biosciences

http://www.dekabiosciences.com

Antios Therapeutics, Inc. (“Antios”), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), and IRBM, a drug discovery and early development research institute and global contract research organization, announced today they entered into an agreement for Antios to purchase the IP rights to a novel series of fourth-generation capsid assembly modulators (CAMs) being developed for the treatment of HBV. The CAMs were originated and developed at IRBM in conjunction with Promidis/CNCCS (a subsidiary of IRBM), Istituto Nazionale Genetica Molecolare (INGM) and San Raffaele Hospital (OSR). These CAMs enable the selection of a new pipeline candidate, which will be the second molecule in Antios’ HBV portfolio. The total potential value of the deal to the Italian sellers/parties is up to $50 million, in addition to royalties.

Derived from a novel chemical scaffold, the CAMs have shown a strong in vitro and in vivo activity in a transgenic mouse model of HBV infection. Early in vivo data point to a differentiated mechanism of action which prevents accumulation of empty capsids, unlike most CAMs, and potentially provides for a more targeted, productive clearance by the immune system. Pre-clinical candidate selection is anticipated in the first half of 2022 with clinical development beginning in mid-2023.

“Unlike traditional CAMs, which target capsid assembly and disassembly, we believe these molecules may have an additional mechanism of action. Their distinct potential in vivo, along with their pre-clinical activity profile to date, position our candidate selection with best-in-class potential among the field,” said Katherine Squires, PhD, Head of Research and Development at Antios. “These particular CAMs will expand the Antios portfolio of differentiated molecules and offer a unique addition to the development of a potentially curative regimen.”

“We hope that the development of these compounds can bring significant benefit to the 296 million people living with this devastating disease,” said Romano Di Fabio, PhD, Corporate Director of Small Molecule R&D at IRBM, whose team designed and then optimized this novel CAM series. Dr. Di Fabio holds more than 70 international patents.

“This agreement is a tribute to the potential of partnerships between Italian academia and industry experts to develop novel therapies to address unmet clinical need,” said Carlo Toniatti, Chief Scientific Officer of IRBM.

“We are pleased to find a home for this program with an experienced team that recognizes the unique potential of these compounds that, in pre-clinical research, showed differentiation from others in its class,” said Luca Guidotti, MD, PhD, a co-inventor and a pioneering HBV researcher who serves as Deputy Scientific Director at OSR.

“Antios, because of its focus on HBV, is the ideal company to guide this program through clinical trials and advance its journey toward potential commercialization,” said Raffaele De Francesco, PhD, Co-inventor of the novel CAM series and Head of the Virology Laboratory at INGM.

Antios’ lead Phase 2b clinical candidate, ATI-2173, is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development, and has potential, if approved, to be the cornerstone of 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.

Destum Partners acted as business development advisor to Antios for this transaction. Closing of the transaction is subject to customary closing conditions, including clearance under the Italian Golden Power legislation.

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.

About IRBM
IRBM is a drug hunting company working primarily as an innovative contract research organization across all aspects of drug discovery and early development for different modalities – small molecule, peptides, and antibodies. IRBM fosters collaborations with organizations from the pharmaceutical, biotech and academic sectors to accelerate drug discovery from target validation and hit identification to candidate nomination. More than 200 scientists work at IRBM’s state-of-the-art R&D facility near Rome where projects are carried out “under one roof” enabling rapid cycle times and close integration of the scientific teams. IRBM’s scientists have discovered several drugs that are on the market, and more than 25 compounds have gone into clinical testing. The company was founded in 2010, as a spin-off from MSD. Now in its 11th year as an independent research organization, IRBM has laid the foundations to become a global Centre for Excellence in all aspects of drug discovery and early development. IRBM’s affiliate, Promidis, is based at the San Raffaele Hospital and conducts research with the objective to discover innovative drugs in areas of unmet need. IRBM is also part of The National Consortium and Collection of Chemical Compounds (CNCCS), a private-public consortium with a mission to identify compounds acting on innovative biological targets. It also acts as a center for translational research in rare, neglected and poverty-related diseases. Both Promidis and CNCCS together with IRBM were involved in the discovery and development of the fourth-generation CAM inhibitors. For more information visit www.irbm.com.  

About INGM
INGM is a biomedical research centre aimed at Preventive Precision Medicine with a special focus on genetics and epigenetics of immunological aspects of chronic diseases (autoimmune, infectious and tumoral). INGM develops translational research projects aimed at the identification of new biomarkers and novel therapeutic targets which could improve secondary and tertiary prevention of human chronic diseases. INGM projects exploit the most advance single cell omics technologies combined with the most advanced big data interrogation tools. For more information visit www.ingm.org.

About OSR
San Raffaele Hospital (OSR) is a large clinical-research-university hospital with more than 60 clinical specialties that provides advanced care for the most complex and difficult health conditions. OSR is part of Gruppo San Donato, the leading hospital group in Italy. Research at OSR involves more than 1,200 scientists and covers all fields of biomedicine. The overall biomedical innovation process is operative at OSR: from basic discoveries made in the labs to therapy design and test in pre-clinical models, up to first phase and pilot clinical trials in humans. The institute is recognized as a global authority in molecular medicine and gene therapy and is at the forefront of research in many other fields, including infectious diseases. OSR currently holds a portfolio of over 600 patents, most of which are licensed to industrial partners for further development. For more information, please visit: www.hsr.it.

SOURCE Antios Therapeutics

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