Vir Biotechnology Announces New Clinical Data From its Broad Hepatitis B Program

– Results from ongoing trials of VIR-2218 and VIR-3434 presented at the International
Liver Congress™ (ILC) 2022 demonstrate durable reductions in hepatitis B surface antigen with no safety signals –

– Company expects to dose first patient in Part B of the Phase 2 MARCH trial by the end of June –

SAN FRANCISCO, June 25, 2022 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced new data from its robust hepatitis B virus (HBV) clinical trial program, including results from an ongoing Phase 2 clinical trial of VIR-2218, results from an ongoing Phase 1 clinical trial of VIR-3434 and preclinical data evaluating both investigational compounds as monotherapy and in combination. Data were presented in one oral and two poster presentations at the International Liver Congress™ (ILC) 2022, the Annual Meeting of the European Association for the Study of the Liver (EASL).

In summary, data presented at ILC demonstrated that a six-dose regimen of VIR-2218 provided greater and more durable reductions in hepatitis B surface antigen (HBsAg) than a two-dose regimen, with all participants achieving a >1 log₁₀ IU/mL reduction during the trial. Phase 1 results evaluating VIR-3434 showed that a single dose (6 mg, 18 mg, 75 mg or 300 mg) resulted in a rapid reduction of HBsAg, with the largest and most durable response noted with the 300 mg dose. Finally, preclinical in vivo data demonstrated that the combination of both investigational compounds resulted in greater HBsAg reductions than either compound alone.

“The data presented at the International Liver Congress 2022 continue to indicate that our therapeutic strategy of combining an antiviral with an immunomodulator to restore immunologic control in patients with chronic HBV is additive and offers the potential for a functional cure,” said Carey Hwang, M.D., Ph.D., Vir’s senior vice president, clinical research, head of chronic infection. “As we continue to evaluate VIR-2218 and VIR-3434, we are encouraged by the potential of these two investigational medicines alone and in combination. These data, alongside the anticipated initiation of Part B of the MARCH trial by the end of June, are important milestones in our broad HBV portfolio for which we expect multiple data readouts throughout 2022 and 2023.”

Hepatitis Portfolio Update

As part of its ongoing efforts to advance its broad HBV portfolio, Vir expects to dose the first patient in Part B of the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial evaluating VIR-2218 in combination with VIR-3434 for 24 and 48 weeks, and in combination with interferon, by the end of June. Previously reported results from Part A demonstrated that VIR-3434 combined with VIR-2218 provided an additional 2 log decline in HBsAg loss over the 3 log decrease with VIR-2218 alone. No drug-related safety signals were observed. Additional data from Part A are expected later this year. However, with clinical trial sites in Ukraine and Moldova, the Company is continuing to monitor the war in Ukraine for any potential impact on timing.

Additional milestones expected in the second half of 2022 include:

• Additional data from the Phase 2 trial of VIR-2218 in combination with PEG-IFN-α.
• Initial data from the Phase 2 trial led by Brii Biosciences evaluating VIR-2218 in combination with BRII-179, an investigational T cell vaccine, for the potential treatment of chronic HBV infection.
• The initiation of a Phase 2 platform trial of VIR-2218 in combination with VIR-3434 in viremic patients (THRIVE/STRIVE sub-protocols), with initial data expected in the second half of 2023.
• The initiation of a Phase 2 trial of VIR-2218 in combination with VIR-3434 for the treatment of chronic hepatitis D virus (HDV) infection, with initial data expected in 2023.

The Company also expects to report initial data from the Phase 2 trial evaluating various combinations of VIR-2218, selgantolimod (GS-9688), Gilead Sciences, Inc.’s investigational TLR-8 agonist, and nivolumab, an approved PD-1 inhibitor, as a potential cure regimen for chronic HBV infection in the first half of 2023.

Summary of ILC 2022 Presentations

Oral Presentation – VIR-2218

Longer treatment duration of monthly VIR-2218 results in deeper and more sustained reductions in hepatitis B surface antigen in participants with chronic hepatitis B infection (Abstract #644)
Young-Suk Lim, M.D., Ph.D., professor, Department of Gastroenterology and Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

Preliminary results from the ongoing Phase 2 trial evaluating the safety, tolerability, and antiviral activity of two dosing regimens (two or six doses of VIR-2218 200 mg given subcutaneously every four weeks) in 21 virally suppressed hepatitis B e antigen (HBeAg)-positive or negative participants with chronic HBV infection demonstrated:

• All participants in the 2- and 6-dose regimens achieved a >1 log₁₀ IU/mL reduction in HBsAg.
• The six-dose regimen was associated with a greater mean maximum HBsAg reduction and more sustained HBsAg reductions than the two-dose regimen with 73% of participants receiving 6 doses of VIR-2218 maintaining ≥ 1 log₁₀ IU/mL reduction in HBsAg from baseline through 40 weeks after the last dose.
• There were no observable differences in safety or tolerability between the two VIR-2218 dosing regimens. No serious treatment-emergent adverse events were reported, and no trial participants discontinued treatment.
  

Poster Presentation – VIR-3434

Dose-dependent durability of hepatitis B surface antigen reductions following administration of a single dose of VIR-3434, a novel neutralizing vaccinal monoclonal antibody (Abstract #654; Poster #SAT357)
Kosh Agarwal, M.D., consultant hepatologist and transplant physician, Institute of Liver Studies at King’s College Hospital, and clinical director, NIHR South London Clinical Research Network

Preliminary data from the placebo-controlled, single ascending dose Phase 1 trial evaluating the safety, tolerability, and antiviral activity of a single ascending dose of VIR-3434 (6 mg, 18 mg 75 mg or 300 mg) administered subcutaneously to 24 participants with HBeAg-negative chronic HBV infection with eight weeks of follow-up, demonstrated:

• Most participants achieved a >1 log₁₀ IU/mL reduction from baseline in HBsAg within one to three days of dosing.
• A single dose of VIR-3434 6 mg, 18 mg, 75 mg or 300 mg demonstrated a rapid reduction in HBsAg, with the largest and most durable HBsAg reductions observed in the 300 mg cohort.
• VIR-3434 was generally well tolerated. All AEs reported were grade 1 or 2 in severity.
  

Poster Presentation – VIR-2218 in Combination with VIR-3434

VIR-2218 plus VIR-3434 combination therapy reduces hepatitis B virus surface antigen levels in vivo (Abstract #3009; Poster #SAT434)
Andrea Cathcart, Ph.D., director, Clinical Virology, Vir Biotechnology

The antiviral activity of VIR-2218 and VIR-3434 as monotherapy and in combination was evaluated in two separate in vivo trials of an animal model of HBV infection. Antiviral activity was determined by evaluating viral serum/plasma markers, including HBV DNA, HBsAg and HBeAg. Results showed:

• In one trial, VIR-2218 monotherapy led to a significant reduction in plasma HBsAg, HBeAg and HBV DNA levels, and VIR-3434 monotherapy significantly reduced plasma HBsAg. The combination of VIR-2218 and VIR-3434 further reduced plasma HBsAg and HBV DNA levels compared with VIR-2218 monotherapy.
• In the other trial, VIR-3434 monotherapy resulted in a substantial decrease in serum HBsAg. Treatment with the combination of VIR-2218 and VIR-3434 showed greater reductions in HBsAg and a reduction in serum HBV DNA levels over monotherapy.

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 Biotechnology 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. 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 HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and also 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 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 clinical data from Vir’s ongoing trials of VIR-2218 and VIR-3434, the ability of VIR-2218 and VIR-3434 (as monotherapies or combination therapies) to treat and/or prevent chronic HBV infection, the timing, design and enrollment plans for the Phase 2 MARCH trial, the timing of Brii Biosciences Phase 2 trial evaluating VIR-2218 in a combination trial with BRII-179, the timing of initial data from the combination of VIR-2218 with TLR-8 agonist and nivolumab, Vir’s plans for its HBV portfolio and clinical development programs, clinical trials, including the enrollment of Vir’s clinical trials, and data readouts.. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials, difficulties in obtaining regulatory approval, difficulties in collaborating with other companies, challenges in accessing manufacturing capacity, clinical site activation rates or clinical trial enrollment rates that are lower than expected, 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.

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