Vir Biotechnology to Present Latest Clinical Data in Hepatitis Delta and B Programs at the European Association for the Study of the Liver (EASL) Congress 2025

• Phase 2 SOLSTICE subgroup analysis data in chronic hepatitis delta selected for poster presentation, and to be highlighted during EASL poster tour

• 24 Week post-treatment follow-up data in chronic hepatitis B from MARCH Phase 2 study to be shared in oral presentation

SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the Company will present data from a 24-week subgroup analysis of its ongoing Phase 2 SOLSTICE trial in chronic hepatitis delta at the upcoming European Association for the Study of the Liver (EASL) Congress 2025 in Amsterdam (The Netherlands), May 7-10. The Company will also present 24 Week post-treatment follow-up data from the MARCH Phase 2 clinical study evaluating combinations of tobevibart and elebsiran, alone, or in combination with pegylated interferon alfa (PEG-IFNα), in participants with chronic hepatitis B. These results follow end-of-treatment data presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting^® 2024, which demonstrated promising rates of hepatitis B surface antigen (HBsAg) loss (seroclearance) in participants with low baseline HBsAg (<1000 IU/mL) in both combination regimens.

Vir Biotechnology will present the following abstracts:

• SOLSTICE Week 24 subgroup analysis: Impact of baseline viral parameters and cirrhosis status on virological and biochemical responses in participants with chronic hepatitis delta virus infection treated with tobevibart and elebsiran
  Session: Poster Tour - Viral Hepatitis B and D: New therapies, unapproved therapies or strategies
  Date: Thursday, May 8
  Time: 16:15 – 17:00h CET
  Presenter: Alina Jucov, M.D., Ph.D., Arensia Exploratory Medicine GmbH, Düsseldorf, Germany, and Nicolae Testemitanu, State University of Medicine and Pharmacy, Chişinău, Moldova
  
  This poster will also be available as part of the following session:
  Session: Poster - Viral Hepatitis B and D: New therapies, unapproved therapies, or strategies
  Date: Thursday, May 8
  Time: 08:30 – 17:00h CET
  

• Outcomes of 48 weeks of therapy and subsequent 24-week post-treatment period with tobevibart (VIR-3434) and elebsiran (VIR-2218) with or without Pegylated Interferon Alfa-2a in chronic hepatitis B virus infection. Findings from the MARCH Study
  Session: General session 2
  Date: Friday, May 9
  Time: 10:30 – 12:30h CET
  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
  

• In vitro characterization of elebsiran (VIR-2218), an investigational siRNA therapeutic targeting hepatitis B virus
  Session: Poster - Viral Hepatitis: Experimental and pathophysiology
  Date: Friday, May 9
  Time: 08:30 – 17:00h CET
  Presenter: Dr. Gregory Camus, Director, Research, Vir Biotechnology, Inc.

About Tobevibart and Elebsiran

Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta and patients with chronic hepatitis B.

Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta and patients with chronic hepatitis B.

About Vir Biotechnology, Inc.

Vir Biotechnology, Inc., is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology 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 “should,” “could,” “may,” “might,” “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. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the therapeutic potential of the combination of tobevibart and elebsiran to treat chronic hepatitis B (with or without PEG-IFNα) and chronic hepatitis delta; Vir Biotechnology’s plans for presenting data from the SOLSTICE and MARCH studies at the EASL Congress 2025; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology’s planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology’s competitors, as well as changes in expected or existing competition; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. 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 studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology’s available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.