Vir Biotechnology Initiates Phase 1 Clinical Trial of VIR-3434 for Chronic Hepatitis B Virus Infection
May 27 2020 - 8:00AM
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.
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 U.S. Food and Drug Administration (FDA) is
undetectable hepatitis B virus surface antigen (HBsAg), defined as
less than 0.05 international units per milliliter, as well as HBV
DNA less than the lower limit of quantification, in the blood six
months after the end of therapy. Currently, a year-long course of
pegylated interferon-alpha (PEG-IFN-α) is the best available
curative therapy. It has a low functional cure rate of
approximately three to seven percent. Alternatively, suppressive
therapy with nucleotide/nucleoside reverse transcriptase inhibitors
(NRTIs) is commonly used, but patients often require a lifetime of
therapy.
About VIR-3434
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.
About VIR-2218
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.
About Vir Biotechnology
Vir Biotechnology is a clinical-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 hepatitis B virus, influenza A,
SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more
information, please visit www.vir.bio.
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,” “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 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.
Contact:
Investors
Neera Ravindran, MD
Head of Investor Relations & Strategic Communications
nravindran@vir.bio
+1-415-506-5256
Media
Lindy Devereux
Scient PR
lindy@scientpr.com
+1-646-515-5730
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