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 March 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: 16 March 2021, London, UK and Quebec City,
Canada
Medicago and GSK start Phase 3 trial of adjuvanted COVID-19 vaccine
candidate
●
Trial
to enrol up to 30,000 volunteers worldwide
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Fast
Track designation granted by US FDA
Medicago, a biopharmaceutical company headquartered in Quebec City,
and GlaxoSmithKline (GSK) are pleased to announce the start of
Phase 3 clinical testing of Medicago's plant-derived COVID-19
vaccine candidate in combination with GSK's pandemic adjuvant, as
part of the ongoing Phase 2/3 study. Medicago received approval
from Canadian and US regulatory authorities to proceed with
enrolment of healthy adults in the Phase 3 portion of the trial
based on positive interim Phase 2 results.
"We are pleased to take the significant step of initiating the
Phase 3 clinical trial at sites around the world," said Takashi
Nagao, CEO and President of Medicago. "This brings us one step
closer to delivering an important new COVID-19 vaccine and
contributing to the global fight against the pandemic along with
our partner GSK."
Thomas Breuer, Chief Medical Officer, GSK Vaccines said, "This
advance to late stage clinical testing further reinforces our
confidence in the adjuvanted vaccine candidate's potential to make
a difference in the continued fight against COVID-19. We look
forward to sharing results later this year."
Medicago's plant-derived vaccine candidate against COVID-19 uses
Coronavirus-Like-Particle (CoVLP) technology with the vaccine
composed of recombinant spike (S) glycoprotein expressed as
virus-like-particles (VLPs) co-administered with GSK's pandemic
adjuvant. Two doses of 3.75lg of CoVLP are administered 21 days
apart.
The vaccine candidate, in combination with the pandemic adjuvant,
was granted Fast Track designation by the U.S. Food and Drug
Administration (FDA) on 17 February 2021. Fast
Track designation allows the FDA to expedite the development
and review of new medicines and vaccines intended to
treat or prevent serious conditions and address an unmet medical
need.
"The FDA's decision to grant Fast Track designation for Medicago's
vaccine candidate will help us expedite our efforts to bring the
first plant-derived COVID-19 vaccine to market, subject to
regulatory approval," said Carolyn Finkle, Chief Operating Officer
of Medicago. "We are grateful to the FDA and look forward
to continuing to work with them as we move forward in our
clinical trials, planned application for
Emergency Use Authorisation and eventual
vaccine licensure application process."
The Phase 3 portion of the study is an event-driven, randomized,
observer-blinded, placebo-controlled, two-way cross-over design
that will evaluate the efficacy and safety of the adjuvanted CoVLP
formulation, compared to placebo. The study will enrol up to 30,000
subjects initially composed of healthy adults (18y to 65y) followed
by elderly adults (65y+) and adults with comorbidities. The trial
will take place in 10 countries pending regulatory approvals,
starting with Canada and the United States, and will enrol males
and females from ethnically and racially diverse
populations.
The Phase 2 portion of the trial is approaching completion and
results are expected to be made publicly available in April
2021.
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 our work with Medicago, a collaboration with Sanofi on
an adjuvanted, protein-based vaccine candidate is now in Phase 2.
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 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 will now seek 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 Medicago
Medicago
is on a mission to improve global public health using the power of
plants. Founded in 1999 with the belief that innovative approaches
and rigorous research would bring new solutions in healthcare,
Medicago is a pioneer in plant-derived therapeutics. We are proudly
rooted in Quebec, with manufacturing capacity in both Canada and
the U.S. Our passionate and curious team of over 450 scientific
experts and employees are dedicated to using our technology to
provide rapid responses to emerging global health challenges, and
to advancing therapeutics against life-threatening diseases
worldwide.
For more information: www.medicago.com
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.
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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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Tim
Foley / Simon
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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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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: March
16, 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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