Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc
(LSE/NYSE: GSK) today provided an update on the VIR-7831
(GSK4182136) arm of the National Institutes of Health’s (NIH)
Accelerating COVID-19 Therapeutic Interventions and Vaccines
(ACTIV) Program Phase 3 clinical trial. The companies were informed
that while VIR-7831 met initial pre-specified criteria to continue
to the next phase of the ACTIV-3 trial and there were no reported
safety signals, sensitivity analyses of the available data raised
concerns about the magnitude of potential benefit. The independent
Data and Safety Monitoring Board (DSMB) has recommended that the
VIR-7831 arm of the trial be closed to enrollment while the data
mature. The companies will continue discussions with the NIH about
appropriate ways to further assess the potential of VIR-7831 in the
hospitalized population as all parties gain a fuller understanding
of the still-emerging data.
The DSMB recommendation was based on a routine,
pre-planned safety and efficacy data review of the first 300
patients hospitalized with COVID-19 enrolled in ACTIV-3.
George Scangos, Ph.D., chief executive
officer of Vir, said: “While we are
disappointed with the recommendation of the DSMB, we are encouraged
by the safety profile of VIR-7831 and by the possibility of a
benefit on top of remdesivir and corticosteroids in this
advanced cohort of patients. We want to thank NIH for their work to
assess the benefits of VIR-7831 and other agents, and look forward
to working with them to further understand the potential of
VIR-7831 to provide a benefit in this population. In addition, we
are eagerly anticipating the upcoming data from the Phase 3
COMET-ICE trial in newly-diagnosed COVID-19 patients at high risk
of hospitalization.”
Christopher Corsico, Senior Vice
President Development, GSK, said: “We want to thank the
patients who participated in this study and the NIH for investing
in the ACTIV trial to evaluate the four monoclonal antibodies, as
it recognizes the need for differentiated treatments, especially as
new variants emerge globally. These and other anticipated data will
provide valuable insights about how VIR-7831 can contribute to
the fight against this pandemic.”
VIR-7831 is an investigational, dual-action
monoclonal antibody that has been shown in preclinical trials to
both block viral entry into healthy cells and clear infected cells,
which may protect patients from disease progression.
The antibody has also shown the ability to
neutralize the SARS-CoV-2 live virus by binding to a highly
conserved epitope of the spike protein, which may make it more
difficult for resistance to develop. So far, the variants of
concern, including the UK, South African and Brazilian variants, do
not overlap with the VIR-7831 targeted epitope of the virus, and,
therefore, VIR and GSK believe that it should maintain full
activity against these strains.
In addition to the ACTIV-3 trial, VIR-7831 is
also being evaluated in the outpatient setting in the following
clinical trials:
- COMET-ICE
(COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care
Early): A Phase 3 trial to evaluate VIR-7831 for the early
treatment of COVID-19 in adults at high risk of hospitalization or
death.
- BLAZE-4 (sponsored
by Eli Lilly and Company): A Phase 2 trial designed to assess the
safety and efficacy of Eli Lilly’s bamlanivimab (LY-CoV555) alone
and bamlanivimab with other neutralizing antibodies, including
VIR-7831, versus placebo in low-risk adults with mild to moderate
COVID-19.
Additionally, VIR-7831, along with VIR-7832,
will be evaluated in the Phase 1b/2a National Health
Service-supported AGILE trial in adults with mild to moderate
COVID-19. VIR-7832 is the second monoclonal antibody from the
Vir-GSK collaboration to be investigated as a potential COVID-19
treatment.
VIR-7831 and VIR-7832 are investigational
compounds, not approved by the U.S. Food and Drug
Administration or any other regulatory authority.
About VIR-7831 /
GSK4182136VIR-7831 is an investigational dual-action
SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the
potential to both block viral entry into healthy cells and clear
infected cells. The antibody binds to an epitope on SARS-CoV-2 that
is shared with SARS-CoV-1 (the virus that causes SARS), indicating
that the epitope is highly conserved, which may make it more
difficult for resistance to develop. VIR-7831, which incorporates
Xencor’s Xtend™ technology, 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 VIR-7832 /
GSK4182137VIR-7832 is an investigational
dual-action SARS-CoV-2 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 that causes SARS), indicating that the epitope is highly
conserved, which may make it more difficult for resistance to
develop. VIR-7832, which incorporates Xencor’s Xtend and other Fc
technologies, 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 also has been engineered to potentially
enhance virus-specific T cell function, which could help treat
and/or prevent COVID-19 infection.
About the Vir and GSK
CollaborationIn 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.
GSK commitment to tackling COVID-19GSK’s
response to COVID-19 has been one of the broadest in the industry,
with two potential treatments in addition to our vaccine candidates
in development.
GSK is collaborating with several organizations
on COVID-19 vaccines by providing access to our adjuvant
technology. In addition to work with Sanofi, our collaboration with
Medicago on an adjuvanted, protein-based vaccine candidate is now
in late-stage clinical trials. An earlier stage collaboration with
SK Bioscience is also ongoing, with funding from CEPI and Bill and
Melinda Gates Foundation, to develop differentiated, affordable
COVID-19 vaccines for supply globally through the COVAX facility.
The use of an adjuvant can be of particular importance in a
pandemic since it may reduce the amount of vaccine protein required
per dose, allowing more vaccine doses to be produced, contributing
to protecting more people.
GSK is also working with mRNA specialist,
CureVac, to jointly develop next generation, multi-valent mRNA
vaccines for COVID-19 with the potential to address multiple
emerging variants in one vaccine. GSK will also support
manufacturing of up to 100m doses of CureVac’s first generation
COVID-19 vaccine, if approved.
GSK is also exploring potential therapeutic or
treatment options for COVID-19 patients. We are collaborating with
Vir Biotechnology to develop existing and identify new anti-viral
antibodies that could be used as therapeutic or preventive options
for COVID-19.
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 COVID-19, hepatitis B virus,
influenza A and human immunodeficiency virus. For more information,
please visit www.vir.bio.
About GSKGSK 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
StatementsThis 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 timing of
availability of clinical data, program updates and data disclosures
related to VIR-7831, the ability of VIR-7831 and VIR-7832 to treat
and/or prevent COVID-19, the potential of VIR-7831 in the
hospitalized population, the ability of VIR-7831 to neutralize the
SARS-CoV-2 live virus and the ability of VIR-7831 to maintain full
activity against variant strains of the virus. Many factors may
cause differences between current expectations and actual results,
including 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:
Cara Miller
VP, Corporate Communications
cmiller@vir.bio
+1 415 941 6746
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(London)
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