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: 18 May 2021, London UK
Medicago and GSK announce positive interim Phase 2 results for
adjuvanted COVID-19 vaccine candidate
●
Similar antibody response in adults
and in the elderly after two doses
●
Neutralizing antibody responses were
ten times higher than in people recovering from
COVID-19
●
No related severe adverse events
reported
Medicago, a biopharmaceutical company headquartered in Quebec City,
and GlaxoSmithKline (GSK) are pleased to report positive interim
Phase 2 clinical trial safety and immunogenicity data for
Medicago's plant-derived COVID-19 vaccine candidate, which has been
tested in combination with GSK's pandemic adjuvant.
These results are part of the ongoing Phase 2/3 study and reiterate
the promising profile observed during Phase 1 testing.
Immunogenicity, as measured by the neutralising antibody titer, was
high: about 10 times higher than those in a panel of sera from
patients recovering from COVID-19. No related severe adverse events
were reported and reactogenicity was generally mild to moderate and
short in duration.
"We are very excited to see such positive results from the Phase 2
data. After two doses, the adjuvanted vaccine candidate induced
robust neutralizing antibody and cellular immune responses in all
subjects, irrespective of age," said Nathalie Landry, Executive
Vice President, Scientific and Medical Affairs at Medicago. "These
results give us confidence as we continue to move forward with our
Phase 3 clinical trial. We hope to add another tool in the global
fight against COVID-19, particularly as cross-protection emerges as
an important consideration in vaccination efforts
worldwide."
Thomas Breuer, Chief Medical Officer, GSK Vaccines said, "We are
delighted to see that the results suggest a very strong immune
response. Medicago's COVID-19 vaccine candidate combined with GSK's
pandemic adjuvant was also well tolerated, reinforcing its
potential benefits. We now look forward to the outcome of the
ongoing Phase 3 trial of this refrigerator-stable vaccine candidate
as the next step forward in our contribution to the global response
to the pandemic."
The Phase 3 trial of the vaccine candidate launched on 16 March
2021. Trial sites are currently enrolling subjects in Canada, the
United States, the United Kingdom and Brazil, with additional sites
expected to be added in the coming weeks. The vaccine candidate has
received Fast Track designation by the FDA in the United States,
and Health Canada has initiated a review of Medicago's COVID-19
rolling submission under the Interim Order.
About Phase 2: Results Summary
The interim data from Phase 2 in adults and in the elderly have
been published on an online preprint server
at MedRxiv.
● This publication focuses on presenting safety and
tolerability results, and immunogenicity, as measured by
neutralizing antibody (NAb) and cell mediated immunity (IFN-c and
IL-4 ELISpot) responses, in adults aged 18-64 (adults) and older
adults aged 65+ (older adults).
● Medicago's vaccine candidate with GSK's pandemic
adjuvant exhibited an acceptable safety profile and adverse events
(AEs) were primarily mild or moderate and of transient
duration.
● AEs in older adults were more limited than those
observed in the adult population.
● Medicago's vaccine candidate with GSK's pandemic
adjuvant induced a significant humoral immune response of similar
strength in both age cohorts after two
doses.
● The vaccine candidate induced a greater humoral
response in adults than older adults after a single dose but after
the second dose both age cohorts responded with NAb titers that
were about 10 times higher than those in a panel of sera from
patients recovering from COVID-19.
About the Phase 2/3 study
The Phase 2/3 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, elderly subjects aged 65 and
over and adults with comorbidities.
The Phase 2 portion of the trial was 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 was conducted in
multiples sites in Canada and the United States in a population
composed of healthy adults (18-64y), elderly adults (over 65y) and
adults with comorbidities. Each age group enrolled up to 306
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 which will be the final analysis.
The Phase 3 portion is an event-driven, randomized,
observer-blinded, crossover placebo-controlled design that will
evaluate the efficacy and safety of the CoVLP formulation, compared
to placebo, in up to 30,000 subjects in North America, Latin
America and Europe and within the same population.
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 Medicago, we recently announced positive
Phase 2 data from our collaboration with Sanofi to develop
an adjuvanted, protein-based
vaccine candidate and expect
to begin a Phase 3 trial in Q2. 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. Based on
experience with other adjuvanted vaccines, there is potential for
increased cross protection against COVID-19 variants which will be
further studied.
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 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 US. 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.
GSK enquiries:
|
|
|
|
Media enquiries:
|
Simon Steel
|
+44 (0) 20 8047 5502
|
(London)
|
|
Simon Moore
|
+44 (0) 20 8047 5502
|
(London)
|
|
Kristen Neese
|
+1 804 217 8147
|
(Philadelphia)
|
|
Kathleen Quinn
|
+1 202 603 5003
|
(Washington DC)
|
|
|
|
|
Analyst/Investor enquiries:
|
James Dodwell
|
+44 (0) 20 8047 2406
|
(London)
|
|
Sonya Ghobrial
|
+44 (0) 7392 784784
|
(Consumer)
|
|
Mick Readey
|
+44 (0) 7990 339653
|
(London)
|
|
Jeff McLaughlin
|
+1 215 751 7002
|
(Philadelphia)
|
|
Frannie DeFranco
|
+1 215 751 4855
|
(Philadelphia)
|
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.
|
GlaxoSmithKline plc
|
|
(Registrant)
|
|
|
Date: May
18, 2021
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GlaxoSmithKline plc
|
GSK (PK) (USOTC:GLAXF)
Historical Stock Chart
From Sep 2024 to Oct 2024
GSK (PK) (USOTC:GLAXF)
Historical Stock Chart
From Oct 2023 to Oct 2024