Vir Biotechnology Initiates Phase 1 Clinical Trial of VIR-3434 for Chronic Hepatitis B Virus Infection
“We firmly believe that a functional cure will require a cocktail of drugs that has both antiviral and immune stimulatory activity. We have selected our drug candidates with this in mind,” said
VIR-3434 is an 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. It has also been Fc engineered to include the XX2 “vaccinal mutation,” for which Vir has licensed exclusive rights for all infectious diseases. VIR-2218, an investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference, is currently being investigated in a Phase 2 trial for the treatment of chronic HBV infection.
“The vaccinal mutations incorporated into the Fc domain of VIR-3434 act in concert to potentially trigger the correct FcGamma receptors on dendritic cells, resulting in their maturation,” said
The Phase 1 clinical trial of VIR-3434 is a randomized, placebo-controlled trial designed to assess the safety, tolerability, pharmacokinetics, antiviral and immunomodulatory activity of VIR-3434 in healthy volunteers and patients with chronic HBV infection. The company plans to enroll patients at multiple trial sites in several countries in the
“The initiation of this clinical trial is welcome news as we pursue new agents that can, either individually or in combination, stop viral replication and reignite the body’s immune response to restore control,” said
About Hepatitis B
Approximately 290 million people globally are chronically infected with HBV and approximately 900,000 of them die from HBV-associated complications each year. There is a significant unmet medical need for more effective therapies that lead to life-long control of the virus after a finite duration of therapy, which is the definition of a functional cure. For a registrational trial to demonstrate a functional cure, the formal endpoint accepted by the
VIR-3434 is a 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 has been engineered to have an extended half-life as well as to potentially function as a T cell vaccine against HBV in infected patients.
VIR-2218 is a 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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend,” “potential,” “to be” 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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the requirements for a functional cure for HBV, the potential benefits of VIR-3434 and VIR-2218 (individually or in combination), and the timing, design and planned program updates and data disclosures for the Phase 1 clinical trial of VIR-3434, including trial enrollment rates and site activation plans. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, difficulty in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, clinical site activation rates or clinical trial enrollment rates that are lower than expected, changes in expected or existing competition, delays or disruptions on our business or clinical trials due to the COVID-19 pandemic, and unexpected litigation or other disputes. 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
Neera Ravindran, MD Head of Investor Relations & Strategic Communicationsnravindran@vir.bio +1-415-506-5256 Media Lindy DevereuxScient PR firstname.lastname@example.org +1-646-515-5730
Source: Vir Biotechnology, Inc.