Clinical-stage immunology company Vir Biotechnology Inc. (VIR:NASDAQ), which is focused on treating and preventing serious infectious diseases, today announced "initial topline data from its ongoing trial of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection."
The firm advised that data from a cohort of eight randomized patients where six participants received a single 6 mg dose of VIR-3434 and two were given a placebo, showed that the six of the eight patients achieved a mean reduction of 1.3 log10 IU/mL in serum hepatitis B virus surface antigen (HBsAg) after eight days.
Vir Biotechnology indicated that "VIR-3434 is a subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and reduce the level of virions and subviral particles in the blood, which has also been Fc engineered to include the XX2 'vaccinal mutation,' allowing it to potentially function as a T cell vaccine, in this case, against HBV."
Kosh Agarwal, M.D., lead study investigator and consultant hepatologist and transplant physician at the Institute of Liver Studies, King's College Hospital NHS Foundation Trust in London, remarked, "The need for a functional cure for the nearly 300 million people living with chronic HBV is paramount. Lowering HBsAg may help unlock a patient's immune system, allowing it to provide the immune control necessary to achieve a functional cure...These early, first-in-patient results are exciting because they demonstrate that even at a very low dose, VIR-3434 is able to markedly lower HBsAg."
Vir Biotechnology's Chief Medical Officer Phillip Pang, M.D., Ph.D., commented, "Extrapolating from our preclinical data, we expected it might require much higher doses of VIR-3434 to achieve this level of HBsAg knockdown. To have achieved it with a dose of 6 mg is unexpected...Coupled with initial data that shows VIR-3434 was well tolerated at up to 3,000 mg in healthy volunteers, I am hopeful that we are seeing just the beginning of VIR-3434's capabilities."
The company stated that the Phase 1 clinical trial was structured as a randomized, placebo-controlled study to evaluate VIR-3434's immunomodulatory activity, pharmacokinetics, tolerability and safety in healthy volunteers and patients with chronic HBV infection with HBsAg levels less than 1,000 IU/ml. The firm noted that "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." The company added that it expects to undertake a Phase 2 study in H2/21 that will involve combining VIR-3434 with VIR-2218, Vir's HBV-targeting siRNA. The firm explained that "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."
The firm also reported that it is also developing a dual-action monoclonal antibody called VIR-7832. The company noted that this monoclonal antibody has been designed to potentially enhance virus-specific T cell function, which might perhaps aid in the treatment and prevention of SARS-CoV-2 infection.
Vir Biotechnology is headquartered in San Francisco and is a clinical-stage immunology company focused on treating and preventing serious infectious diseases. The company has developed four technology platforms created to stimulate and enhance the immune system and identify and observe natural immune processes. The company stated that its product pipeline candidates are being developed to target hepatitis B, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis.
Vir Biotechnology began the day with a market capitalization of around $5.7 billion with approximately 127.4 million shares outstanding and a short interest of about 10.5%. VIR shares opened slightly higher today at $45.00 (+$0.61, +1.37%) over yesterday's $44.39 closing price. The stock has traded today between $44.60 to $69.77 per share and is currently trading at $65.84 (+$21.45, +48.33%).[NLINSERT]
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