SAN FRANCISCO, June 07, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that five abstracts highlighting new data from the Company’s broad hepatitis portfolio addressing both hepatitis B virus (HBV) and hepatitis D virus (HDV) have been accepted for presentation at the annual meeting of the European Association for the Study of the Liver, EASL™ Congress 2023, taking place in Vienna from June 21-24.
“The accepted abstracts underscore the progress Vir is making with our robust hepatitis B and D portfolio and the potential impact the combination of VIR-3434 and VIR-2218 could have on both viruses,” said Phil Pang, M.D., Ph.D., Vir’s Executive Vice President, Chief Medical Officer and Interim Head of Research. “We look forward to sharing new data from our clinical development programs that give us confidence in our approach toward a functional cure for HBV and a treatment for the long-term suppression of HDV.”
The late-breaker oral presentation, which was accepted as the only HBV-focused late-breaker abstract, will provide new data related to the safety and efficacy of VIR-2218 with or without pegylated interferon alfa (PEG-IFN-α) in virally-suppressed participants with chronic HBV infection.
A second oral presentation will share follow-up data from Part A of the Phase 2 MARCH trial. Originally presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® in November 2022, Part A was designed to, and successfully demonstrated, the on-treatment additivity of VIR-2218 and VIR-3434. Importantly, these short-duration Part A cohorts, in which these investigational treatments were co-administered for only four or 12 weeks, informed the protocol for Part B, which is designed to evaluate whether VIR-3434 and VIR-2218, given with or without PEG-IFN-α for 24 and 48 weeks, can result in a functional cure for chronic HBV. Initial on-treatment data from the 24-week cohorts are anticipated in the second half of 2023.
Finally, three poster presentations will focus on the potential efficacy of VIR-2218 and VIR-3434 in preclinical models of HDV, the pharmacokinetics of HBV monotherapy with VIR-3434, and the eligibility and initiation of HBV treatment in a real-world setting.
Presentation details are as follows:
Late-Breaker Oral Presentation
- Title: Safety and efficacy of VIR-2218 with or without pegylated interferon alfa in virally-suppressed participants with chronic hepatitis B virus infection: post-treatment follow-up (Oral Presentation #LBO-02)
Session: Late-Breaker Session
Date: Saturday, June 24
Time: 11:15-11:30 CEST (5:15-5:30 a.m. EDT)
Presenter: Prof. Man-Fung Yuen, M.D., Ph.D., D.Sc., Professor of Medicine, Queen Mary Hospital, School of Clinical Medicine; State Key Laboratory of Liver Research, The University of Hong Kong
Oral Presentation
- Title: Safety and antiviral activity of short-duration combinations of the investigational small interfering ribonucleic acid (siRNA) VIR-2218 with the neutralizing, vaccinal monoclonal antibody VIR-3434: post-treatment follow-up from the Phase 2 MARCH trial (Abstract #1273; Oral Presentation #OS-031)
Session: Viral hepatitis B/D – New treatments
Date: Thursday, June 22
Time: 17:30-17:45 CEST (11:30-11:45 a.m. EDT)
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
Poster Presentations
- Title: VIR-2218 and VIR-3434 therapy is efficacious in preclinical models of hepatitis delta virus infection (Abstract #1333; Poster #TOP-109)
Session: Viral hepatitis B and D: New therapies, unapproved therapies or strategies
Date: Saturday, June 24
Time: Available from 9:00 CEST (from 3:00 a.m. EDT)
Presenter: Florian Lempp, Ph.D., Director, Virology, Vir Biotechnology
- Title: Single dose pharmacokinetics of VIR-3434, a novel neutralizing monoclonal antibody, in participants with chronic hepatitis B virus infection (Abstract #1305; Poster #SAT-177)
Session: Viral hepatitis B and D: New therapies, unapproved therapies or strategies
Date: Saturday, June 24
Time: Available from 9:00 CEST (from 3:00 a.m. EDT)
Presenter: Sneha V. Gupta, Ph.D., Director, Clinical Pharmacology, Vir Biotechnology
- Title: Treatment eligibility and initiation among chronic hepatitis B patients in a real-world setting in the United States (Abstract #2613; Poster #WED-141)
Session: Viral hepatitis B and D: Clinical aspects
Date: Wednesday, June 21
Time: Available from 9:00 CEST (from 3:00 a.m. EDT)
Presenter: Mark A. Schmidt, Ph.D., M.P.H., infectious disease epidemiologist, Kaiser Permanente Center for Health Research
The EASL presentation abstracts can be accessed under Events & Presentations in the Investors section of the Vir website here.
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/or 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 Chronic Hepatitis D
Chronic hepatitis D virus (HDV) infection occurs as a simultaneous co-infection or super-infection with hepatitis B virus (HBV). An estimated 12 million people globally are infected with HDV, representing approximately 5% of those infected with HBV. HDV-HBV co-infection is considered the most severe form of chronic viral hepatitis due to more rapid progression toward hepatocellular carcinoma and liver-related death.
About VIR-2218
VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that Vir believes has the potential to stimulate an effective immune response and have direct antiviral activity against HBV and 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 could 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 hepatitis B and hepatitis D 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, 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 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, preliminary data and the potential benefits, safety and efficacy of VIR-2218, VIR-3434, VIR-2218 in combination with VIR-3434 and VIR-2218 and VIR-3434 in combination with PEG-IFNα; the initial results of the MARCH clinical trial evaluating the combination of VIR-2218 and VIR-3434; Vir’s expectations related to the potential success of its current and future clinical development programs for HBV and HDV; Vir’s plans and expectations for its HBV portfolio; and risks and uncertainties associated with drug development and commercialization. Many important factors may cause differences between current expectations and actual results, including the MARCH trial 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 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.
