Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc
(LSE/NYSE: GSK) today announced an agreement with the U.K.-based
AGILE initiative to evaluate VIR-7832 in patients with mild to
moderate COVID-19 in a Phase 1b/2a clinical trial. VIR-7832 is a
neutralizing COVID-19 antibody that preclinical data suggests has
two distinguishing properties: an enhanced ability to clear
infected cells and the potential to enhance virus-specific T-cell
function, which could help treat and/or prevent COVID-19 infection.
The AGILE trial platform, which will be the
first to test VIR-7832 in humans, uses adaptable protocols and
statistical models to enable the evaluation of candidate medicines
for COVID-19 treatment. The initiative is a collaboration between
the University of Liverpool, Liverpool School of Tropical Medicine,
Liverpool University Hospitals NHS Foundation Trust, University of
Southampton and Lancaster University and coordinated by the
National Institute for Health Research Southampton Clinical Trials
Unit across the UK Clinical Research Facility Network. The trial is
due to begin in the first quarter of 2021.
George Scangos, Ph.D., chief executive
officer of Vir, said: “We are pleased to have the support
of the NHS behind our efforts to evaluate and advance VIR-7832 for
the treatment and potential prevention of COVID-19. This study will
be critical to our efforts as we work to understand whether the
modifications we have made to this monoclonal antibody increase its
potency and stimulate a T cell response to not only provide
therapeutic benefits but also potentially confer a vaccine-like
effect that could be applicable to prophylaxis.”
Dr. Hal Barron, chief scientific officer
and president R&D, GSK, said: “While vaccine
development has been very successful, current infection and
hospitalization rates show that multiple vaccines and therapeutic
options will be needed to combat and ultimately end this pandemic.
We are grateful to everyone involved in the AGILE study for
supporting this important research and expect initial results from
the study to provide important insights into the use of VIR-7832
early in the course of infection with SARS-CoV-2.”
VIR-7832 is set to become the second monoclonal
antibody from the Vir-GSK collaboration to be investigated as a
potential COVID-19 treatment. The first antibody, VIR-7831, is
currently being investigated in two global phase 3 studies; for the
early treatment of COVID-19 in patients who are at high risk of
hospitalization, and for the treatment of hospitalized patients
with COVID-19.
Phase 1b/2a AGILE Study
DesignAGILE is a randomized, controlled, multi-center,
seamless, adaptive Phase 1b/2a platform for the rapid evaluation of
candidates of COVID-19 treatment in hospitalized patients and also
in the community with early disease. The AGILE platform will assess
VIR-7832 and VIR-7831 in adult outpatients with mild to moderate
COVID-19 infection. The dose-escalation Phase 1b part of the study
will evaluate the safety and tolerability of a single dose of
VIR-7832 given by intravenous (IV) infusion and determine the dose
for evaluation in the Phase 2a part of the study. A total of 24
study participants will be randomized 3:1 to VIR-7832 or placebo.
The Phase 2 part of the study will include three treatment arms: 50
patients randomized to VIR-7832, 50 patients to VIR-7831, and 25
patients to placebo. The co-primary endpoints are safety and
virologic activity of VIR-7832 as assessed by a change in
SARS-CoV-2 viral load from baseline to Day 8. The Phase 2 part of
the study also will assess the T cell responses to SARS-CoV-2 of
VIR-7832 and VIR-7831. The trial is being conducted at up to five
sites in the UK.
About VIR-7832 /
GSK4182137VIR-7832 is a dual-action monoclonal antibody.
Preclinical data suggest it has the potential to both block viral
entry into healthy cells and an enhanced ability to clear infected
cells. The antibody binds to an epitope on SARS-CoV-2 that is
shared with SARS-CoV-1 (the virus which causes SARS), indicating
that the epitope is highly conserved, which may make it more
difficult for resistance to develop. VIR-7832 also has been
designed to achieve high concentration in the lungs to ensure
optimal penetration into airway tissues affected by SARS-CoV-2 and
to have an extended half-life. Importantly, VIR-7832 has been
engineered to potentially enhance virus-specific T cell function,
which could help treat and/or prevent COVID-19 infection.
About VIR-7831 /
GSK4182136VIR-7831 is a dual-action monoclonal antibody.
Preclinical data suggest it has the potential to both block viral
entry into healthy cells and an enhanced ability to clear infected
cells. The antibody binds to an epitope on SARS-CoV-2 that is
shared with SARS-CoV-1 (the virus which causes SARS), indicating
that the epitope is highly conserved, which may make it more
difficult for resistance to develop. VIR-7831 also has been
designed to achieve high concentration in the lungs to ensure
optimal penetration into airway tissues affected by SARS-CoV-2 and
to have an extended half-life.
About the Vir and GSK
Collaboration In April 2020, Vir and GSK entered into a
collaboration to research and develop solutions for coronaviruses,
including SARS-CoV-2, the virus that causes COVID-19. The
collaboration uses Vir’s proprietary monoclonal antibody platform
technology to accelerate existing and identify new anti-viral
antibodies that could be used as therapeutic or preventive options
to help address the current COVID-19 pandemic and future outbreaks.
The companies will leverage GSK’s expertise in functional genomics
and combine their capabilities in CRISPR screening and artificial
intelligence to identify anti-coronavirus compounds that target
cellular host genes. They will also apply their combined expertise
to research SARS-CoV-2 and other coronavirus vaccines.
About Vir BiotechnologyVir
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 SARS-CoV-2, hepatitis B virus,
influenza A, human immunodeficiency virus and tuberculosis. For
more information, please visit www.vir.bio.
About GSK GSK is a science-led
global healthcare company with a special purpose: to help people do
more, feel better, live longer. For further information please
visit www.gsk.com/about-us.
Vir 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,”
“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 the potential benefits of VIR-7832
and VIR-7831 in the treatment of COVID-19, the potential benefits
of participating in the AGILE study, and statements around the
expected timing of the Phase 1b/2a clinical trial. Many factors may
cause differences between current expectations and actual results,
including delays or failures in planned patient enrollment or
retention, clinical site activation rates or clinical trial
enrollment rates that are lower than expected, unexpected safety or
efficacy data observed during preclinical or clinical studies,
challenges in the treatment of hospitalized patients, difficulties
in collaborating with other companies or government agencies,
challenges in accessing manufacturing capacity, successful
development and/or commercialization of alternative product
candidates by our competitors, changes in expected or existing
competition, delays in or disruptions to our business or clinical
trials due to the COVID-19 pandemic, geopolitical changes or other
external factors, and unexpected litigation or other disputes.
GSK Cautionary Statement Regarding
Forward-Looking StatementsGSK cautions investors that any
forward-looking statements or projections made by GSK, including
those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially
from those projected. Such factors include, but are not limited to,
those described under Item 3.D "Risk Factors" in the company's
Annual Report on Form 20-F for 2019 and as set out in GSK’s
“Principal risks and uncertainties” section of the Q2 Results and
any impacts of the COVID-19 pandemic.
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Vir Biotechnology Contacts:
Investors
Neera Ravindran, M.D.
VP, Head of Investor Relations & Strategic Communications
nravindran@vir.bio
+1 415 506 5256
Media
Cara Miller
VP, Corporate Communications
cmiller@vir.bio
+1 415 941 6746
GSK Contacts:
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Danielle Smith +44 (0) 20 8047 0932 (London)
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