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Vir Biotechnology Initiates Phase 1 Clinical Trial of VIR-3434 for Chronic Hepatitis B Virus Infection
Novel investigational HBV-neutralizing monoclonal antibody with therapeutic vaccine-like properties
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May 27, 2020 08:00 ET | Source: Vir Biotechnology, Inc.
SAN FRANCISCO, May 27, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the initiation of a Phase 1 clinical trial of VIR-3434, an investigational monoclonal antibody that neutralizes hepatitis B virus (HBV) and has been engineered to potentially also act as a therapeutic vaccine. The commencement of first-in-human dosing marks the start of Vir’s second clinical program aimed at a functional cure for HBV.
“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 Phillip Pang, M.D., Ph.D., Chief Medical Officer of Vir. “In the case of VIR-3434, it is remarkable to have a drug candidate that by itself has the potential to be both an antiviral and a therapeutic vaccine. When combined with our siRNA candidate, VIR-2218, we believe that this cocktail could achieve very high rates of functional cure.”
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 Jeffrey V. Ravetch, M.D., Ph.D., Theresa and Eugene M. Lang Professor and Head of the Leonard Wagner Laboratory of Molecular Genetics and Immunology at The Rockefeller University, who discovered these mutations and their role. “If they work in humans the way they do in mice, after this antibody has captured an HBV virion or subviral particle, we believe the antibody will deliver this payload to immature dendritic cells, stimulating them to mature and subsequently result in HBV specific T cells.”
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 Asia Pacific and European regions. The trial is designed to progress from healthy volunteers to chronic HBV patients in a staggered, parallel fashion with the goal of rapidly generating early proof-of-concept data in patients. Data are expected to be available in 2021.
“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 Edward J. 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 and a lead investigator of the trial. |
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