TIDMGSK
RNS Number : 9207X
GlaxoSmithKline PLC
03 September 2020
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:
Media enquiries: Simon Steel +44 (0) 20 8047 (London)
5502
Simon Moore +44 (0) 20 8047 (London)
5502
Kristen Neese +1 804 217 8147 (Philadelphia)
Kathleen Quinn +1 202 603 5003 (Washington
DC)
Analyst/Investor Sarah Elton-Farr +44 (0) 20 8047 (London)
enquiries: 5194
Sonya Ghobrial +44 (0) 7392 (Consumer)
784784
Danielle Smith +44 (0) 20 8047 (London)
0932
James Dodwell +44 (0) 20 8047 (London)
2406
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)
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.
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