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 September 2020
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: 3 September 2020, London, UK and Paris, France
Sanofi and GSK
initiate Phase 1/2 clinical trial of COVID-19 adjuvanted
recombinant protein-based vaccine candidate
● Pre-clinical studies show promising safety and
immunogenicity
● Over 400 participants being enrolled in Phase 1/2
study
● If Phase 1/2 data positive, companies aim to move
into a Phase 3 trial by end of 2020
● Sanofi and GSK are scaling up manufacturing of the
antigen and adjuvant with the target of producing up to one billion
doses in 2021
Sanofi and GSK announce today the start of the Phase 1/2 clinical
trial for their adjuvanted COVID-19 vaccine. The vaccine candidate,
developed in partnership by Sanofi and GSK, uses the same
recombinant protein-based technology as one of Sanofi's seasonal
influenza vaccines with GSK's established pandemic adjuvant
technology.
The Phase 1/2 clinical trial is a randomised, double blind and
placebo-controlled trial designed to evaluate the safety,
reactogenicity (tolerability) and immunogenicity (immune response)
of the COVID-19 vaccine candidate. A total of 440 healthy adults
are being enrolled in the trial across 11 investigational sites in
the United States.
The Companies anticipate first results in early December 2020, to
support the initiation of a Phase 3 trial in December 2020.
If these data are sufficient for licensure application, it is
planned to request regulatory approval in the first half of
2021.
Sanofi is leading the clinical development and registration of the
COVID-19 vaccine. Pre-clinical data showed an acceptable
reactogenicity profile and data based on two injections of the
adjuvanted recombinant vaccine showed high levels of neutralising
antibodies that are comparable to levels in humans who recovered
from the COVID-19 infection. Pre-clinical results will be published
later this year. In parallel, Sanofi and GSK are scaling up
manufacturing of the antigen and adjuvant with the target of
producing up to one billion doses in 2021.
Thomas Triomphe, Executive Vice President and Global Head of Sanofi
Pasteur, said: "Sanofi and GSK bring proven science and technology
to the fight against the global COVID-19 pandemic, with the shared
objective of delivering a safe and effective vaccine. The
initiation of our clinical study is an important step and
brings us closer to a potential vaccine which could help
defeat COVID-19. Our dedicated teams and partner continue to
work around the clock as we aim to deliver the first results
in early December. Positive data will enable a prompt start of the
pivotal phase 3 trial by the end of this year."
Roger Connor, President of GSK Vaccines said: "Moving this vaccine
candidate into clinical development is an important moment in the
progress towards addressing the global pandemic we are all facing.
This builds on the confidence shown by governments already in the
potential of this protein-based adjuvanted vaccine candidate, which
utilises established technology from both companies, and can be
produced at scale by two of the leading vaccine manufacturers
globally. We now look forward to the data from the study, and if
positive, beginning a Phase 3 trial by the end of the
year."
The development of the adjuvanted COVID-19 vaccine candidate is
being supported through funding and a collaboration with 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.
Sanofi and GSK are committed to making the vaccine available
globally
In July 2020, Sanofi and GSK announced a collaborative effort with the U.S.
government to supply up to 100 million doses of their COVID-19
recombinant protein-based vaccine to meet the U.S. government's
Operation Warp Speed goal of making hundreds of millions of doses
of safe and effective COVID-19 vaccines available in the United
States as quickly as possible. The U.S. government has a further
option to discuss the purchase of up to 500 million doses longer
term. Both companies also agreed (subject to final contract) with the UK
government to supply up to 60 million doses of recombinant
protein-based COVID-19 vaccine.
The partners plan to supply a significant portion of total
worldwide available supply in 2021/2022 to COVAX, the vaccines
pillar of the ACT-Accelerator (Access to COVID‐19
Tools), a global collaboration of leaders of governments, global
health organisations, businesses and philanthropies to accelerate
development, production, and equitable access to COVID-19 tests,
treatments, and vaccines.
GSK commitment to tackling COVID-19
GSK is collaborating with companies and research groups across the
world working on promising COVID-19 vaccine candidates through the
use of our innovative vaccine adjuvant technology. The use of an
adjuvant is of particular importance in a pandemic situation since
it may reduce the amount of vaccine protein required per dose,
allowing more vaccine doses to be produced and therefore
contributing to protecting more people. GSK does not expect
to profit from COVID-19 vaccines during the pandemic phase, and
will invest any short-term profit in coronavirus related research
and long-term pandemic preparedness, either through GSK internal
investments or with external partners.
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.
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.
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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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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Sarah Elton-Farr
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+44 (0) 20 8047 5194
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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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Danielle Smith
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+44 (0) 20 8047 0932
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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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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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 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.
Registered in England & Wales:
No.
3888792
Registered Office:
980 Great West
Road
Brentford,
Middlesex
TW8
9GS
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: September
03, 2020
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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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