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 May 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: 27 May 2021, London UK
Sanofi and GSK initiate global Phase 3 clinical efficacy study of
COVID-19 vaccine candidate
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Two-stage design will evaluate vaccine
formulations targeting original D.614 virus as well as B.1.351
variant, in diverse geographies with multiple circulating
variants
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A booster study programme will begin
in the coming weeks to complement the Phase 3
trial
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Pending positive Phase 3 outcomes and
regulatory reviews, the vaccine could be approved
in Q4 2021
Today, Sanofi and GlaxoSmithKline plc (GSK) started enrolment in
their Phase 3 clinical study to assess the safety, efficacy and
immunogenicity of their adjuvanted recombinant-protein COVID-19
vaccine candidate. The global randomized, double-blind,
placebo-controlled Phase 3 study will include more than 35,000
volunteers aged 18 and older from several countries, including
sites in the US, Asia, Africa and Latin America.
The primary endpoint of the study is the prevention of symptomatic
COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints
being the prevention of severe COVID-19 disease and prevention of
asymptomatic infection. In a two-stage approach, the study will
initially investigate the efficacy of a vaccine formulation
targeting the original D.614 virus (Wuhan), while a second stage
will evaluate a second formulation targeting the B.1.351 (South
African) variant. Recent scientific evidence shows that antibodies
created against the B.1.351 variant may provide broad
cross-protection against other more transmissible
variants.1 The
design of the Phase 3 study,
conducted across a broad diversity of geographies, also allows
evaluation of the efficacy of the candidate against a variety of
circulating variants.
Following encouraging interim results from the recent Phase 2
study, the companies will also begin clinical studies in the coming
weeks to assess the ability of the adjuvanted recombinant-protein
COVID-19 vaccine candidate to generate a strong booster response
regardless of the initial vaccine platform received.
"We are encouraged to see first vaccinations starting to take place
in such an important, pivotal Phase 3 study, as we believe that our
unique technology platform will provide a clinically-relevant
vaccine option," said Thomas Triomphe, Executive Vice President,
Global Head of Sanofi Pasteur. "We have adapted our vaccine
development strategy based on forward-looking considerations as the
virus continues to evolve, as well as anticipating what may be
needed in a post-pandemic setting. This trial is testament to the
urgency and agility in our approach to help overcome the ongoing
impact of this pandemic."
Roger Connor, President of GSK Vaccines added, "We believe further
solutions for COVID-19 are very much needed to help reach people
around the world, especially as the pandemic evolves and variants
continue to emerge. Adjusting our technology and study designs
reflects this need and will further build the potential of this
adjuvanted protein-based vaccine. We are grateful to the volunteers
who will take part in the trials and hope the results will add to
the encouraging data we've seen so far so we can make the vaccine
available as quickly as possible."
The Phase 3 study follows the interim Phase
2 results which showed that the
adjuvanted recombinant COVID-19 vaccine candidate achieved high
rates of neutralizing antibody responses in all adult age groups,
with 95 to100% seroconversion rates. After a single injection, high
neutralizing antibody levels were also generated in participants
with evidence of prior SARS-CoV-2 infection, suggesting strong
potential for development as a booster vaccine.
Pending positive Phase 3 outcomes and regulatory reviews, the
vaccine could be approved/ authorized in Q4 2021. Manufacturing
will begin in the coming weeks to enable rapid access to the
vaccine should it be approved.
This effort is supported by federal funds from the Biomedical
Advanced Research and Development Authority, part of the office of
the Assistant Secretary for Preparedness and Response at the U.S.
Department of Health and Human Services in collaboration with the U.S. Department of
Defense Joint Program Executive Office for Chemical, Biological,
Radiological and Nuclear Defense under Contract #
W15QKN-16-9-1002.
About the GSK / Sanofi partnership
In the partnership between the two companies, Sanofi provides its
recombinant antigen and GSK contributes its pandemic adjuvant, both
established vaccine platforms that have proven successful against
influenza. The recombinant technology combined with GSK's adjuvant
is designed to offer the advantages of stability at temperatures
used for routine vaccines, making it easily implementable and
easier to distribute at a global scale through existing
infrastructures where vaccines are stored at normal refrigerator
temperature. It is also designed to offer the potential to generate
high and sustained immune responses, and the potential to prevent
virus transmission.
GSK commitment to tackling COVID-19
GSK's response to COVID-19 has been one of the broadest in the
industry, with three potential treatments in addition to our
vaccine candidates in development with partner
organisations.
GSK is collaborating with several organisations on COVID-19
vaccines by providing access to our adjuvant technology. In
addition to our work with Sanofi, our collaboration with Medicago
on an adjuvanted, plant-derived vaccine candidate is now in
late-stage clinical trials. An earlier stage collaboration with SK
Bioscience is also ongoing. SK Bioscience receives funding from
CEPI and the 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 and 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. GSK is also providing
manufacturing support for up to 60m doses of Novavax' COVID-19
vaccine in the UK.
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. We
recently reported that an Independent Data Monitoring Committee
recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 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, based on an interim analysis of data from the
trial. We have received
Emergency Use Authorization in the U.S. and are seeking
authorisations in other countries. We are also assessing whether an
investigational monoclonal antibody, otilimab, can help severely
ill COVID-19 patients aged over 70 who experience an overreaction
of their immune system.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
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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Simon
Moore
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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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Mick
Readey
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+44 (0)
7990 339653
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(London)
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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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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 on Form 20-F for 2020 and any impacts of the COVID-19
pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
Reference
1. Moyo-Gwete,
T. et al. SARS-CoV-2 501Y.V2 (B.1.351) elicits cross-reactive
neutralizing antibodies. bioRxiv (2021).
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: May
27, 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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