Vir Biotechnology Announces SOLSTICE Data to be Featured as an Oral Presentation at the European Association for the Study of the Liver (EASL) Congress 2024

Rhea-AI Summary

Vir Biotechnology announced that the European Association for the Study of the Liver (EASL) Congress 2024 has upgraded its Phase 2 SOLSTICE hepatitis delta presentation from a late-breaker poster to an oral presentation. The presentation will take place on June 8 during the EASL Congress in Milan, Italy, which runs from June 5-8. The company will also host an investor call on June 5 to discuss the new SOLSTICE data, including 12-week and 24-week treatment outcomes. Additional 48-week data on the efficacy and safety of tobevibart and elebsiran will be provided, complementing data shared at the 2023 AASLD Liver Meeting.

Positive

• EASL Congress upgraded the SOLSTICE presentation to an oral presentation, indicating high interest and potential validation.
• Investor call scheduled on June 5 to discuss new data enhances transparency and investor engagement.
• Presentation includes comprehensive data points, covering 12, 24, and 48-week treatment outcomes.
• Positive forward-looking statement with additional 24-week data expected in Q4 2024.

Negative

• No new financial information provided, leading to potential concerns over the company's current financial health.
• Pending results from additional 24-week data sets may introduce uncertainties.

SAN FRANCISCO--(BUSINESS WIRE)-- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the EASL Congress has changed the Company’s Phase 2 SOLSTICE hepatitis delta presentation from a late-breaker poster to an oral presentation. The SOLSTICE data will be presented on June 8 during the annual meeting of the European Association for the Study of the Liver, EASL™ Congress 2024, taking place in Milan, Italy, June 5-8. The Company plans to host an investor conference call to discuss the new SOLSTICE data on June 5. The update will include data on participants that have reached 12 and 24 weeks of chronic suppressive treatment. The Company will also share 48-week treatment data on the efficacy and safety of tobevibart and elebsiran for the participants that were previously reported on at the 2023 American Association for the Study of Liver Diseases (AASLD) The Liver Meeting^®.

The SOLSTICE trial (NCT05461170) is evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta. New data will be presented from the cohorts evaluating the de novo combination of tobevibart and elebsiran dosed every four weeks and tobevibart monotherapy every two weeks. Additional 24-week data from these cohorts are expected in the fourth quarter of 2024.

About Tobevibart (VIR-3434)

Tobevibart 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. Tobevibart, 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. Tobevibart was identified using Vir’s proprietary monoclonal antibody discovery platform.

About Elebsiran (VIR-2218)

Elebsiran is an investigational subcutaneously administered hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) that Vir believes has the potential to stimulate an effective 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. Elebsiran 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 powering the immune system to transform lives by treating and preventing infectious diseases and other serious conditions, including viral-associated diseases. Vir has assembled two technology platforms that are designed to modulate the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis delta and hepatitis B 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 tobevibart and elebsiran, the potential benefits, safety and efficacy of tobevibart and elebsiran, the timing, nature and significance of data from Vir’s multiple ongoing trials evaluating tobevibart and elebsiran, Vir’s plans and expectations for its CHD and CHB programs, 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240516732892/en/

Media

Carly Scaduto

Senior Director, External Communications

cscaduto@vir.bio

+1 314-368-5189

Investors

Richard Lepke

Senior Director, Investor Relations

rlepke@vir.bio

+1 978-973-9986

Source: Vir Biotechnology, Inc.

FAQ

What is Vir Biotechnology's SOLSTICE trial?

The SOLSTICE trial is a Phase 2 study evaluating the safety, tolerability, and efficacy of tobevibart and elebsiran in treating chronic hepatitis delta.

When will Vir Biotechnology present the SOLSTICE data?

Vir Biotechnology will present the SOLSTICE data on June 8, 2024, at the EASL Congress in Milan, Italy.

What will be discussed in the Vir Biotechnology investor call on June 5, 2024?

The investor call will discuss the new SOLSTICE data, including 12-week and 24-week treatment outcomes for chronic hepatitis delta.

What treatments are being evaluated in the SOLSTICE trial?

The SOLSTICE trial is evaluating tobevibart and elebsiran, with new data including a combination dosed every four weeks and tobevibart monotherapy every two weeks.

What are the key dates related to Vir Biotechnology's SOLSTICE trial data presentation?

Key dates include an investor call on June 5, 2024, and an oral presentation on June 8, 2024, at the EASL Congress.