SAN FRANCISCO, Oct. 31, 2022 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that four abstracts highlighting new data from its hepatitis B virus (HBV) clinical program have been accepted for presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®, taking place in Washington, D.C., from November 4-8, 2022. These include two poster presentations, one of which is a late-breaking poster, and two oral presentations, both of which have been selected by AASLD for inclusion in the “Best of the Liver Meeting” summary.
The first oral presentation will highlight new safety, tolerability and antiviral activity data from the Phase 2 MARCH trial, the first clinical trial combining VIR-2218 and VIR-3434. VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) that diminishes the level of all HBV proteins in vitro, including hepatitis B surface antigen (HBsAg). VIR-3434 is an investigational HBsAg-targeting monoclonal antibody designed to remove HBV virions from the blood and block the entry of the virus into liver cells and potentially act as a therapeutic vaccine.
The second oral presentation will highlight additional safety, efficacy and follow-up data of VIR-2218 alone and in combination with pegylated interferon alfa (PEG-IFNα) in participants with chronic HBV infection.
The first poster presentation will highlight data indicating that a single 75 or 300 mg dose of VIR-3434 is associated with reductions in hepatitis B viral DNA and HBsAg in the majority of viremic participants with chronic HBV infection in the absence of nucleot(s)ide reverse transcriptase inhibitor (NRTI) therapy.
The late-breaker poster presentation will focus on the characteristics of chronic hepatitis B patients that were enrolled in a 20-year real-world study of treatment patterns in a U.S. health care delivery system.
Oral Presentations
- Title: Safety, tolerability, and antiviral activity of the siRNA VIR-2218 in combination with the investigational neutralizing monoclonal antibody VIR-3434 for the treatment of chronic hepatitis B virus infection: Preliminary results from the Phase 2 MARCH trial (Abstract #33496)
Session: Novel Therapeutic Approaches Aimed at Functional Cure of Hepatitis B and D
Date: Sunday, November 6
Time: 9:00 a.m. ET
Presenter: Prof. Edward Gane, M.D., Professor of Medicine at the University of Auckland, New Zealand, and Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital
- Title: Preliminary 48-week safety and efficacy of VIR-2218 alone and in combination with pegylated interferon alfa in participants with chronic HBV infection (Abstract #33507)
Session: Novel Therapeutic Approaches Aimed at Functional Cure of Hepatitis B and D
Date: Sunday, November 6
Time: 10:15 a.m. ET
Presenter: Prof. Man-Fung Yuen, D.Sc., M.D., Ph.D., MBBS, Deputy Department Chairperson, Chief of Division of Gastroenterology and Hepatology, Master of Lap-Chee College, The University of Hong Kong, Li Shu Fan Medical Foundation Professor in Medicine
Poster Presentation
- Title: Reduction in hepatitis B viral DNA and hepatitis B surface antigen following administration of a single dose of VIR-3434, an investigational, neutralizing monoclonal antibody: first experience in a population with viremia (Abstract #36195; Poster #1187)
Session: Poster Session I
Date: Friday, November 4
Time: 12:00-1:00 p.m. ET
Presenter: Kosh Agarwal, M.D., Consultant Hepatologist and Transplant Physician at the Institute of Liver Studies, Kings College Hospital, London, United Kingdom
Late-Breaker Poster Presentation
- Title: Characteristics of chronic hepatitis B patients enrolled in a 20-year, real-world study of treatment patterns in a U.S. health care delivery system (Abstract #38827; Poster #5045)
Session: Poster Session IV
Date: Monday, November 7
Time: 1:00-2:00 p.m. ET
Presenter: Sacha Satram, Ph.D., Director, Health Economics & Outcomes Research at Vir Biotechnology
About Chronic Hepatitis B
Chronic hepatitis B virus (HBV) infection remains an urgent global public health challenge associated with significant morbidity and mortality. Approximately 300 million people around the world are living with HBV, and approximately 900,000 of them die from associated complications each year. These patients are significantly underserved by existing therapies with low functional cure rates, lifelong daily therapy and poor tolerability. Vir is working to achieve a functional cure for the millions of people with HBV around the world through its broad and differentiated portfolio.
About VIR-2218
VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV and hepatitis D virus (HDV). It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. VIR-2218 is the first asset in the Company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.
About VIR-3434
VIR-3434 is an investigational subcutaneously administered antibody designed to block entry of HBV and HDV viruses into hepatocytes and to reduce the level of virions and subviral particles in the blood. VIR-3434, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to potentially function as a T cell vaccine against HBV and HDV in infected patients, as well as to have an extended half-life.
About Vir Biotechnology
Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B and hepatitis D viruses, influenza A and human immunodeficiency virus. Vir routinely posts information that may be important to investors on its website.
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,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Vir’s strategy and plans, the potential clinical effects of VIR-2218 and VIR-3434, the potential benefits, safety and efficacy of VIR-2218 and VIR-3434, the initial results of the MARCH trial, Vir’s plans and expectations for its HBV portfolio, and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; successful development and/or commercialization of alternative product candidates by Vir’s competitors; changes in expected or existing competition; delays in or disruptions to Vir’s business or clinical trials due to the COVID-19 pandemic, geopolitical changes (including the war in Ukraine) or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
