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: 17 May 2021, London UK
Sanofi and GSK COVID-19 vaccine candidate demonstrates strong
immune responses across all adult age groups in Phase 2
trial
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Adjuvanted
recombinant COVID-19 vaccine candidate triggered strong
neutralizing antibody responses in all adult age
groups
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High
immune response after a single dose in patients with prior
infection shows strong booster potential
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Global
Phase 3 study expected to start in the coming weeks
The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine
candidate achieved strong rates of neutralizing antibody responses,
in line with those measured in people who have recovered from
COVID-19, in all adult age groups in a Phase 2 study with 722
volunteers. A global pivotal Phase 3 study is expected to start in
the coming weeks.
The Phase 2 interim results showed 95% to 100% seroconversion
following a second injection in all age groups (18 to 95 years old)
and across all doses, with acceptable tolerability and with no
safety concerns. Overall, the vaccine candidate elicited strong
neutralizing antibody levels that were comparable to those
generated by natural infection, with higher levels observed in
younger adults (18 to 59 years old). After a single injection, high
neutralizing antibody levels were generated in participants with
evidence of prior SARS-CoV-2 infection, suggesting strong potential
for development as a booster vaccine.
"Our Phase 2 data confirm the potential of this vaccine to play a
role in addressing this ongoing global public health crisis, as we
know multiple vaccines will be needed, especially as variants
continue to emerge and the need for effective and booster vaccines,
which can be stored at normal temperatures, increases," said Thomas
Triomphe, Executive Vice President and Head of Sanofi Pasteur.
"With these favourable results, we are set to progress to a global
Phase 3 efficacy study. We look forward to generating additional
data and working with our partners around the world to make our
vaccine available as quickly as possible."
Roger Connor, President of GSK Vaccines added, "These positive data
show the potential of this protein-based adjuvanted vaccine
candidate in the broader context of the pandemic, including the
need to address variants and to provide for booster doses. We
believe that this vaccine candidate can make a significant
contribution to the ongoing fight against COVID-19 and will move to
Phase 3 as soon as possible to meet our goal of making it available
before the end of the year."
Based on these positive Phase 2 interim results, the Companies plan
to initiate a global Phase 3 randomized, double-blind study with
the 10µg dose, in combination with GSK's pandemic adjuvant, in
the coming weeks. The Phase 3 trial is expected to enrol more than
35,000 adult participants from a broad range of countries and will
assess the efficacy of two vaccine formulations including the D614
(Wuhan) and B.1.351 (South African) variants.
In parallel, the Companies intend to conduct booster studies with
various variant formulations in order to assess the ability of a
lower dose of the vaccine to generate a strong booster response
regardless of the initial vaccine platform received.
Pending positive Phase 3 outcomes and regulatory reviews, the
vaccine is expected to be approved in the fourth quarter of
2021.
About the Phase 2 study
The Phase 2 study interim results show that the adjuvanted
recombinant vaccine candidate triggered a strong immune response
amongst adults of all age groups with 95% to 100% seroconversion
rates and neutralizing antibodies that were comparable to those
generated by natural infection. The high titers observed in the
non-naïve population after one dose of the vaccine candidate
also suggest it may have strong potential for use as a booster
vaccine. Full results of the Phase 2 study will be published in a
peer-reviewed journal.
The randomized, double-blind, multi-center dose-ranging study was
conducted in healthy adults aged 18 years of age and older,
including those with high risk medical conditions, to evaluate the
safety, reactogenicity, and immunogenicity of two injections given
21 days apart, with 3 antigen dose levels of 5, 10 and 15 µg.
Beginning in February 2021, the study enrolled 722 volunteers, in
the U.S. and Honduras. It included equivalent numbers of adults 18
to 59 years and those 60 years and above.
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 also offers 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 are seeking Emergency Use Authorization in the US and
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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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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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
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
17, 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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