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 November 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: GlaxoSmithKline plc ("GSK"), 12 November 2020, London, UK
and Quebec City, Canada
Medicago and GSK announce start of Phase 2/3 clinical trials of
adjuvanted COVID-19 vaccine candidate
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The
COVID-19 vaccine candidate will contain GSK's pandemic
adjuvant
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Phase
3 part of clinical trial to enrol over 30,000 volunteers
worldwide
Medicago, a biopharmaceutical company headquartered in Quebec City,
and GSK are pleased to announce the start of Phase 2/3 clinical
trials of its plant-derived vaccine candidate for COVID-19 to
evaluate its efficacy, safety, and immunogenicity. Based on
the positive Phase 1 results, Medicago has decided to launch the
Phase 2/3 clinical trial with GSK's pandemic adjuvant.
Nathalie Landry, Executive Vice President, Scientific and Medical
Affairs at Medicago, said: "Our Phase 1 results of the adjuvanted
vaccine candidate were very encouraging and fully support further
clinical evaluation."
Thomas Breuer, Chief Medical Officer GSK Vaccines said: "This is
the first of several GSK COVID-19 vaccine candidate collaborations
to start Phase 2/3 clinical testing and an important step forward
in our contribution to the global fight against the pandemic. We
are delighted with the very promising Phase 1 results of Medicago's
COVID-19 vaccine candidate in combination with GSK's pandemic
adjuvant. Proven dose sparing and a high immune response due to
GSK's adjuvant make us confident of delivering an efficacious
vaccine with an acceptable safety profile in collaboration with
Medicago."
The Coronavirus-Like Particle COVID-19 vaccine candidate (CoVLP) is
composed of recombinant spike (S) glycoprotein expressed as
virus-like particles (VLPs).
The study is a multi-portion design to confirm that the chosen
formulation and dosing regimen of CoVLP (two doses of 3.75 µg
CoVLP combined with GSK's pandemic adjuvant given 21 days apart)
has an acceptable immunogenicity and safety profile in healthy
adults 18-64 years of age and in elderly subjects aged 65 and
over.
The Phase 2 trial part is a randomized, observer-blind,
placebo-controlled study to evaluate the safety and immunogenicity
of the adjuvanted recombinant COVID-19 plant-derived vaccine
candidate in subjects aged 18 and above. It will be conducted in
multiple sites in Canada and, upon FDA allowance, in the United
States and in a population composed of healthy adults (18-64y) and
elderly adults (over 65y). Each age group will have over 300
subjects randomized 5:1 to receive the adjuvanted CoVLP vaccine
candidate: placebo and with 2:1 stratification in older adults
(65-74 and ≥75). All subjects will be followed for a period
of 12 months after the last vaccination for the assessment of
safety and durability of the immune responses to the vaccine
candidate.
The Phase 3 part of the study will start before the end of 2020 and
is an event-driven, randomized, observer-blinded,
placebo-controlled design that will evaluate the efficacy and
safety of the CoVLP formulation, compared to placebo, in over
30,000 subjects in North America, Latin America and/or Europe and
within the same population, or - alternatively - amongst a broader
one pending approval by regulatory authorities.
About Medicago
Medicago is a biopharmaceutical company and pioneer in
plant-derived therapeutics. Founded in 1999 with the belief that
innovative approaches and rigorous research would bring new
solutions in healthcare.
Our mission is to improve global health outcomes by leveraging
innovative plant-based technologies for rapid responses to emerging
global healthcare challenges. Medicago is committed to advancing
therapeutics against life-threatening diseases worldwide. Our
team includes over 450 scientific experts and employees in Canada
and the United States and academic affiliations in Europe and South
Africa.
Medicago has previously demonstrated its capability to be a first
responder in a flu pandemic. In 2009, the company produced a
research-grade vaccine candidate against H1N1 in just 19 days. In
2012, Medicago manufactured 10 million doses of a monovalent
influenza vaccine candidate within one month for the Defense
Advanced Research Projects Agency (DARPA), part of the U.S.
Department of Defense. In 2015, Medicago also demonstrated in
principle that it could rapidly produce an anti-Ebola monoclonal
antibody cocktail for the Biomedical Advanced Research and
Development Authority (BARDA), part of the U.S. Department of
Health and Human Services.
For more information: www.medicago.com
To learn more about our plant-based
technology: Video
/ Website
About GSK and its commitment to tackling COVID-19
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 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.
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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Medicago Media contacts
(English):
Alissa
Von Bargen
+1-647-234-5975
Medicago Media contact
(French):
Marie-Pier
Côté
+
1-418-999-4847
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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 Q3 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: November
12, 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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