TIDMGSK
RNS Number : 8512U
GlaxoSmithKline PLC
07 December 2021
Issued: 7 December 2021, London UK and Quebec City, Canada
Medicago and GSK announce positive Phase 3 efficacy and safety
results for adjuvanted plant-based COVID-19 vaccine candidate
-- Primary endpoints and secondary endpoints for which data are
available were met in trial dominated by COVID-19 variants
-- Efficacy demonstrated against all variants seen in the study,
including 75.3% efficacy against COVID-19 of any severity caused by
the globally dominant Delta variant
-- Vaccine candidate was well-tolerated, with no related serious
adverse events reported in the vaccine group
-- Final regulatory submission to be filed with Health Canada imminently
Medicago, a biopharmaceutical company headquartered in Quebec
City, and GlaxoSmithKline plc (GSK) today announce positive
efficacy and safety results from the global Phase 3
placebo-controlled efficacy study of Medicago's plant-based
COVID-19 vaccine candidate in combination with GSK's pandemic
adjuvant, conducted in over 24,000 subjects (adults 18 years and
above) across six countries.
Vaccine efficacy was demonstrated in an environment dominated by
SARS-CoV-2 variants, unlike most published Phase 3 efficacy trials
for currently licensed COVID-19 vaccines that were conducted when
only the ancestral virus was circulating, making direct comparisons
impossible. The overall vaccine efficacy rate against all variants
of SARS-COV-2 was 71% (95% CI: 58.7, 80.0; Per Protocol Analysis:
PP). The corresponding number for people with an initial
seronegative status indicating no previous exposure to COVID-19 was
75.6% (95% CI: 64.2-83.7; PP). The vaccine candidate demonstrated
efficacy of 75.3% (95% CI: 52.8, 87.9; PP) against COVID-19 of any
severity for the globally dominant Delta variant. Efficacy was
88.6% (95% CI: 74.6, 95.6; PP) against the Gamma variant. Although
only a small number of severe cases occurred in this study, none
occurred in the vaccinated group. No cases of the Alpha, Lambda and
Mu variants were observed in the vaccinated group while 12 cases
were observed in the placebo group. The Omicron variant was not
circulating during the study.
During the study, no related serious adverse events were
reported and reactogenicity was generally mild to moderate and
transient; symptoms lasting on average only one to three days. To
date, the Phase 3 results have confirmed the safety profile is
consistent with Phase 2 results. The frequency of mild fever was
low (<10%), even after the second dose. Full results of the
Phase 3 study will be released in a peer-reviewed publication as
soon as possible.
Based on these results, Medicago will imminently seek regulatory
approval from Health Canada as part of its rolling submission. The
vaccine candidate is not yet approved by any regulatory
authority.
"This is an incredible moment for Medicago and for novel vaccine
platforms. The results of our clinical trials show the power of
plant-based vaccine manufacturing technology. If approved, we will
be contributing to the world's fight against the COVID-19 pandemic
with the world's first plant-based vaccine for use in humans," said
Takashi Nagao, CEO and President at Medicago. "I want to thank
everyone who participated in our clinical trials, our collaborators
at clinical trial sites, our partners at GSK, the Government of
Canada and Government of Quebec, all of our employees and
Mitsubishi Tanabe Pharma Corporation, for their commitment to
advancing vaccine science when the world needs it. "
Thomas Breuer, GSK's global COVID-19 adjuvanted vaccines lead
and Chief Global Health Officer, said, "These are encouraging
results given data were obtained in an environment with no
ancestral virus circulating. The global COVID-19 pandemic is
continuing to show new facets with the current dominance of the
Delta variant, upcoming Omicron, and other variants likely to
follow. The combination of GSK's established pandemic adjuvant with
Medicago's plant-based vaccine technology has significant potential
to be an effective, refrigerator-stable option to help protect
people against SARS-CoV-2."
Medicago has been developing its plant-based technology for the
past 20 years, using unique technology to produce Virus-Like
Particles (VLP) for its protein vaccines. VLPs are designed to
mimic the native structure of viruses, allowing them to be easily
recognised by the immune system. Because the VLPs lack core genetic
material, they are non-infectious and unable to replicate. VLP
vaccines developed by other technologies have traditionally been
used worldwide for more than 30 years.
"I am pleased to see our vaccine candidate moving forward and
bringing to the world the first plant-based vaccine against
COVID-19, diversifying the pool of vaccines available to help
improve public health and protect more people," said Yosuke Kimura,
Chief Scientific Officer at Medicago.
Medicago has initiated the regulatory filing process for the
adjuvanted plant-based COVID-19 vaccine candidate with the FDA (US)
and the MHRA (UK). Preliminary discussion is underway with the WHO
for preparation of the submission. Medicago has also initiated a
Phase 1/2 trial in Japan where it plans to submit for regulatory
approval in combination with the Phase 2/3 global study results
next spring.
About the Phase 2/3 study
The Phase 2/3 study has a multi-portion design to confirm that
the chosen formulation and dosing regimen of the vaccine candidate
(two doses of 3.75 ug of antigen combined with GSK's pandemic
adjuvant given 21 days apart) has an acceptable vaccine 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-based
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 vaccine
candidate: placebo and with 2:1 stratification in older adults
(65-74 and >=75). All subjects are being followed for a period
of 12 months after the last vaccination for assessment of safety
and the durability of the immune responses which will be the final
analysis.
The Phase 3 portion of the trial was launched in March 2021 and
was an event-driven, randomized, observer-blinded, crossover
placebo-controlled design that evaluated the efficacy and safety of
the vaccine candidate formulation, compared to placebo, in over
24,000 subjects across Canada, the United States, United Kingdom,
Mexico, Argentina, and Brazil.
The data communicated are Per-Protocol, meaning only data from
participants who followed the protocol throughout the study are
included. A parallel Intention to Treat (ITT) analysis that
considers the treatment received by all participants, without
regard to protocol adherence yielded very similar results.
The vaccination regimen calls for two doses (3.75 microgram of
antigen in combination with GSK's pandemic adjuvant) given
intramuscularly 21 days apart. The vaccine is stored at 2 degC to 8
degC, enabling the use of traditional vaccine supply and cold chain
channels.
GSK commitment to tackling COVID-19
GSK's response to COVID-19 has been one of the broadest in the
industry, with 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. We are
working with Sanofi, Medicago and SK bioscience to develop
adjuvanted, protein-based vaccines, and all are now in Phase III
clinical trials. 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 protect more people in need.
GSK is also working with mRNA specialist, CureVac, to jointly
develop next generation, optimised mRNA vaccines for COVID-19 with
the potential to address multiple emerging variants in one
vaccine.
GSK is also exploring treatments for COVID-19 patients,
collaborating with Vir Biotechnology to investigate monoclonal
antibodies that could be used as therapeutic or preventive options
for COVID-19.
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 500 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.
Medicago is an affiliated company of Mitsubishi Tanabe Pharma
Corporation.
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: Tim Foley +44 (0) 20 8047 (London)
5502
Simon Moore +44 (0) 20 8047 (London)
5502
Kristen Neese +1 804 217 8147 (Philadelphia)
Kathleen Quinn +1 202 603 5003 (Washington
DC)
Analyst/Investor Nick Stone +44 (0) 7717 (London)
enquiries: 618834
Sonya Ghobrial +44 (0) 7392 (Consumer)
784784
James Dodwell +44 (0) 20 8047 (London)
2406
Mick Readey +44 (0) 7990 (London)
339653
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, GSK's 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
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCUPGPCPUPGGGM
(END) Dow Jones Newswires
December 07, 2021 06:59 ET (11:59 GMT)
Gsk (LSE:GSK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Gsk (LSE:GSK)
Historical Stock Chart
From Apr 2023 to Apr 2024
