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 February 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: 22 February 2021, London UK
Sanofi and GSK initiate new Phase 2 study of their adjuvanted
recombinant protein-based COVID-19 vaccine candidate
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New
Phase 2 study assesses potential for refined antigen formulation to
achieve optimal immune response, including in older
adults
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If
results are positive, Phase 3 study to start in Q2 2021, with
vaccine expected to be available in Q4 2021
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In
parallel, development work on new SARS-CoV-2 variants
underway
Sanofi and GlaxoSmithKline (GSK) announced today the initiation of
a new Phase 2 study with 720 volunteers aged 18 and
over to select the most appropriate antigen dosage for Phase 3
evaluation of their adjuvanted recombinant protein COVID-19 vaccine
candidate.
"Over the past few weeks, our teams have worked to refine the
antigen formulation of our recombinant-protein vaccine, based on
learnings from our initial Phase 1/2 study." said Thomas Triomphe,
Executive Vice President and Head of Sanofi Pasteur. "We are
confident that our vaccine candidate has strong potential and we
are very encouraged by the latest preclinical data. This new Phase
2 study will enable us to identify the final vaccine formulation
for adults of all ages. We have demonstrated our commitment to
focusing efforts and capabilities towards the global fight against
the pandemic, and this new study takes us a step closer to
achieving our primary goal of developing a COVID-19 vaccine with a
good efficacy and safety profile."
Roger Connor, President of GSK Vaccines added, "We are pleased to be starting this new Phase 2
study. The world needs multiple vaccines and we are confident that
combining our proven pandemic adjuvant system with this improved
antigen formulation will have significant potential as the pandemic
evolves. We look forward to further progressing this vaccine
candidate to Phase 3 in Q2 2021, if this Phase 2 study is
successful."
In parallel to the new Phase 2 study and recognising the global
emergence of new SARS-CoV-2 variants and their potential impact on
vaccine efficacy, Sanofi has commenced development work against new
variants which will be used to inform the next stages of the
Sanofi/GSK development programme.
About the Phase 2 study
The new Phase 2 trial is a randomized, double-blind, multi-centre
dose finding study conducted in adults aged 18 years of age and
older to evaluate the safety, reactogenicity, and immunogenicity of
two injections given 21 days apart. The trial will include equal
numbers of adults 18 to 59 years and those 60 years and
above.
Three different antigen doses with a fixed dose of adjuvant will be
tested in a total study population of 720 volunteers, in the United
States, Honduras and Panama. Results of the Phase 2 trial will
inform the Phase 3 protocol.
In December 2020, Phase 1/2 study results showed an
immune response comparable to patients who had recovered from
COVID-19 in adults aged 18 to 49 years, but a lower immune response
in older adults, likely due to an insufficient concentration of the
antigen. If data from the new Phase 2 trial are positive, a global
Phase 3 study is planned for Q2 2021. Positive results from the
Phase 3 study would lead to regulatory submissions in the second
half of 2021, with the vaccine expected to be available in Q4 2021,
if approved.
The advancement of the trial programme is supported by the United
States' Biomedical Advanced Research and Development Authority
(BARDA), part of the HHS Office of the Assistant Secretary for
Preparedness and Response under contract W15QKN-16-9-1002. Sanofi
and GSK's adjuvanted recombinant protein-based COVID-19 vaccine
candidate was selected in
July 2020 by the U.S. government in order to accelerate its
development and manufacturing.
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
could offer the advantages of stability at temperatures used for
routine vaccines, the ability 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 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.
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 are
also assessing whether an investigational monoclonal antibody,
otilimab, can help some severely ill COVID-19 patients 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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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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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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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 Q4 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: February
22, 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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