UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of March 2021
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 11 March 2021, London UK and San Francisco US - LSE
announcement
Vir Biotechnology and GSK announce VIR-7831 reduces hospitalisation
and risk of death in early treatment of adults with
COVID-19
●
Independent
Data Monitoring Committee recommends stopping Phase 3 COMET-ICE
trial early given an 85% reduction in hospitalisation or
death.
●
Vir
and GSK plan to immediately seek Emergency Use Authorization in the
US and authorisations in other countries.
●
Additional
new in vitro studies indicate VIR-7831 maintains activity against
major circulating COVID-19 variants.
Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc
(LSE/NYSE: GSK) today announced that an Independent Data
Monitoring Committee (IDMC) recommended that the Phase 3
COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to
Care Early) trial evaluating VIR-7831 (GSK4182136) as monotherapy
for the early treatment of COVID-19 in adults at high risk of
hospitalisation be stopped for enrolment due to evidence of
profound efficacy.
The IDMC recommendation was based on an interim analysis of data
from 583 patients enrolled in the COMET-ICE trial, which
demonstrated an 85% (p=0.002) reduction in hospitalisation or death
in patients receiving VIR-7831 as monotherapy compared to placebo,
the primary endpoint of the trial. VIR-7831 was well
tolerated. As the trial remains ongoing and blinded with patients
continuing to be followed for 24 weeks, additional results,
including epidemiology and virology data, will be forthcoming once
the trial is completed.
Based on these results, Vir and GSK plan to submit an Emergency Use
Authorization (EUA) application to the U.S. Food and Drug
Administration (FDA) and for authorisations in other countries.
Data from this registrational trial will also form the basis for a
Biologics License Application (BLA) submission to the
FDA.
The companies also announced today the results of a new study
submitted and pending online publication in bioRxiv, demonstrating
that VIR-7831 maintains activity against current circulating
variants of concern including the UK, South African and Brazilian
variants, based on in vitro data from pseudotyped virus assays. In
contrast to other monoclonal antibodies, VIR-7831 binds to a highly
conserved epitope of the spike protein, which may make it more
difficult for resistance to develop.
In addition to COMET-ICE, the full COMET clinical development
programme for VIR-7831 includes:
●
COMET-PEAK: An ongoing Phase 2 trial with two parts: to
compare the safety and viral kinetics of 500 mg intramuscularly
(IM) administered VIR-7831 to 500 mg intravenously administered
VIR-7831 among low-risk adults with mild to moderate COVID-19 and
to evaluate the similarity and pharmacokinetics between VIR-7831
manufactured by different processes.
●
COMET-TAIL: A Phase 3 trial expected to begin in the
second quarter of 2021 in high-risk adults to assess whether
IM-administered VIR-7831 can reduce hospitalisation or death due to
COVID-19.
●
COMET-STAR: A Phase 3 trial expected to begin in the
second quarter of 2021 in uninfected adults at high risk to
determine whether IM-administered VIR-7831 can prevent symptomatic
infection.
George Scangos, Ph.D., Chief Executive Officer of Vir
said: "These exciting data
with a single antibody against a conserved epitope bring us one
step closer to delivering an effective new solution to patients
around the globe. The dual-action design of VIR-7831 to both block
viral entry into healthy cells and clear infected cells, as well as
its high barrier to resistance, are key distinguishing
characteristics. These findings, paired with our pending
publication of resistance data, demonstrate the potential of
VIR-7831 to prevent the most severe consequences of COVID-19 and
highlight its potential ability to protect against the current
circulating strains of the virus."
Dr. Hal Barron, Chief Scientific Officer and President R&D,
GSK said: "We are
pleased that this unique monoclonal antibody was able to bring such
a profound benefit to patients. We look forward to the possibility
of making VIR-7831 available to patients as soon as possible and to
further exploring its potential in other
settings."
The Phase 3 portion of the COMET-ICE trial assessed the safety and
efficacy of a single intravenous infusion of VIR-7831 (500 mg) or
placebo in non-hospitalised participants globally, and this interim
analysis included 291 patients in the treatment arm and 292
patients in the placebo arm. The primary efficacy endpoint is the
proportion of patients who have progression of COVID-19 as defined
by the need for hospitalisation for at least 24 hours or death
within 29 days of randomisation. Among those studied, 63% were
Hispanic or Latinx and 7% were Black or African American. According
to the Centers for Disease Control and Prevention these populations
are approximately three times more likely to be
hospitalised[1] and
approximately two times more likely to die[2] of
COVID-19.
VIR-7831 is also being evaluated in the outpatient setting in
BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company,
designed to assess the safety and efficacy of Eli Lilly's
bamlanivimab (LY-CoV555) alone and bamlanivimab with other
neutralising 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.
COMET-ICE clinical trial design
The multi-centre, double-blind, placebo-controlled COMET-ICE trial
is investigating VIR-7831 in adults with mild or moderate COVID-19
who are at high risk of progression to severe disease. The Phase 1
lead-in portion of the trial, which served as the first-in-human
assessment, evaluated the safety and tolerability of a single 500
mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day
period in 21 non-hospitalised adults enrolled across the United
States.
In October 2020, based on a positive evaluation of safety and
tolerability data of VIR-7831 from the lead-in part of the trial by
an Independent Data Monitoring Committee, the trial began enrolling
patients in North
America and additional sites in South America and Europe in the
global Phase 3 portion of the trial. This part of the trial is
assessing the safety and efficacy of a single IV infusion of
VIR-7831 or placebo in up to 1,300 non-hospitalised participants
globally.
About VIR-7831 / GSK4182136
VIR-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
/ GSK4182137
VIR-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 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.
GSK Commitment to Tackling COVID-19
GSK'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 organisations 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.
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 COVID-19, hepatitis B virus,
influenza A and human immunodeficiency virus. 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.
GSK enquiries:
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Media
enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Kristen
Neese
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+1 804
217 8147
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(Philadelphia)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Analyst/Investor
enquiries:
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Sonya
Ghobrial
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+44 (0)
7392 784784
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(Consumer)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 4855
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(Philadelphia)
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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 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, the ability of VIR-7831 to maintain full activity
against variant strains of the virus and statements related to the
planned full analysis of the COMET-ICE trial. 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
statements
GSK
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 in the Company's
Annual Report published on 9 March 2021 or contained in the
Company's Form 20-F for 2019 and any impacts of the COVID-19
pandemic.
Inside information
This announcement contains inside information. The person
responsible for arranging the release of this announcement on
behalf of GSK is Victoria Whyte, Company Secretary.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
[1] Data
source: COVID-NET (https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covid-net/purpose-methods.html,
accessed March 1, 2020, through January 30, 2021). Numbers are
ratios of age-adjusted rates standardized to the 2019 US standard
COVID-NET catchment population.
[2] Data
source: NCHS provisional death counts (https://data.cdc.gov/NCHS/Deaths-involving-coronavirus-disease-2019-COVID-19/ks3g-spdg,
data through January 30, 2021). Numbers are ratios of age-adjusted
rates standardized to the 2019 US intercensal population
estimate.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: March
11, 2021
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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