TIDMGSK
RNS Number : 4257S
GlaxoSmithKline PLC
16 March 2021
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
-- 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 3.75<MU>g 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 .
GSK enquiries:
Media enquiries: Simon Steel +44 (0) 20 8047 (London)
5502
Tim Foley / Simon +44 (0) 20 8047 (London)
5502
Kristen Neese +1 804 217 8147 (Philadelphia)
Kathleen Quinn +1 202 603 5003 (Washington
DC)
Analyst/Investor James Dodwell +44 (0) 20 8047 (London)
enquiries: 2406
Sonya Ghobrial +44 (0) 7392 (Consumer)
784784
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.
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