Vir Biotechnology to Present Late-Breaking Data from Its Ongoing Phase 2 Chronic Hepatitis B and Delta Trials at AASLD’s The Liver Meeting® 2023

By: Vir Biotechnology, Inc. via Business Wire

November 10, 2023 at 08:00 AM EST

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that it will be presenting new data from its Phase 2 trials evaluating the potential clinical impact that VIR-3434 and VIR-2218 could have for chronic hepatitis B (CHB) and chronic hepatitis delta (CHD) patients at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting^®, taking place in Boston, MA, from November 10-14, 2023. These include one late-breaking poster presentation and one late-breaking oral presentation.

Late-Breaking Presentations

Title: VIR-2218 and VIR-3434 With or Without Pegylated Interferon Alfa-2A for the Treatment of Chronic HBV Infection: End of Treatment (EOT) Results After 24 Weeks of Therapy (March Study Part B) (Abstract #48500)

Session: Late Breaking Poster Session

Date: Monday, November 13

Time: 1:00 p.m. ET

Presenter: 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: The Monoclonal Antibody VIR-3434 And siRNA VIR-2218 for the Treatment of Chronic Hepatitis D Virus: Preliminary Results from the Phase 2 SOLSTICE Trial (Abstract #5004)

Session: Oral, Late Breaking Parallel Session

Date: Monday, November 13

Time: 3:00 p.m. ET

Presenter: Tarik Asselah, M.D., Ph.D., Professor of Hepatology at the Hôpital Beaujon, APHP, Clichy, France, and at the University of Paris, and Head of Viral Hepatitis at INSERM UMR1149, France

The AASLD late breaking presentation abstracts can be accessed under Events & Presentations in the Investors section of the Vir website here.

Vir will host an investor conference call to discuss the Phase 2 CHD & CHB AASLD data at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on November 13th. A live webcast will be available on https://investors.vir.bio and will be archived on www.vir.bio for 30 days.

About Chronic Hepatitis B

Chronic hepatitis B (CHB) infection remains an urgent global public health challenge associated with significant morbidity and mortality. Approximately 300 million people around the world are living with CHB, 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 CHB around the world through its broad and differentiated portfolio.

About Chronic Hepatitis Delta

Chronic hepatitis delta (CHD) infection occurs as a simultaneous co-infection or super-infection with chronic hepatitis B. An estimated 12 million people globally are infected with CHD, representing approximately 5% of those infected with CHB. CHB-CHD 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-3434

VIR-3434 is an investigational subcutaneously administered antibody designed to block entry of hepatitis B and hepatitis delta 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 hepatitis B virus and hepatitis delta virus, as well as to have an extended half-life. VIR-3434 was identified using Vir’s proprietary monoclonal antibody discovery platform.

About VIR-2218

VIR-2218 is an investigational subcutaneously administered hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) that Vir believes has the potential to stimulate an immune response and have direct antiviral activity against hepatitis B virus and hepatitis delta virus. 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 Biotechnology, Inc.

Vir Biotechnology, Inc. is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions. Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses and human immunodeficiency virus. Vir has several preclinical candidates in its pipeline, including those targeting influenza A and B, COVID-19, RSV/MPV and HPV. 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-3434 and VIR-2218, the potential benefits, safety and efficacy of VIR-3434 and VIR-2218, data from Vir’s multiple ongoing trials evaluating VIR-3434 and VIR-2218, Vir’s plans and expectations for its HBV and HDV portfolios, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231106658171/en/

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Carly Scaduto

Senior Director, Media Relations

cscaduto@vir.bio

+1-314-368-5189

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Sasha Damouni Ellis

Executive Vice President, Chief Corporate Affairs Officer

sdamouni@vir.bio

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Vir Biotechnology to Present Late-Breaking Data from Its Ongoing Phase 2 Chronic Hepatitis B and Delta Trials at AASLD’s The Liver Meeting® 2023

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