TIDMGSK
RNS Number : 3053I
GlaxoSmithKline PLC
11 December 2020
Issued:11 December 2020, London and Paris
Sanofi and GSK announce a delay in their adjuvanted recombinant
protein-based COVID-19 vaccine programme to improve immune response
in the elderly
-- Phase 1/2 interim results showed an immune response
comparable to patients who recovered from COVID-19 in adults aged
18 to 49 years
-- Insufficient response in older adults demonstrates the need
to refine the concentration of antigen in order to provide
high-level immune response across all age groups
-- Companies plan a Phase 2b study with an improved antigen formulation
-- With support from BARDA as part of Operation Warp Speed,
study to start in February 2021, including a proposed comparison
with an authorised COVID-19 vaccine
-- Product availability now expected in Q4 2021 pending
successful completion of the development plan
Sanofi and GSK announce a delay in their adjuvanted recombinant
protein-based COVID-19 vaccine program to improve immune response
in older adults. Phase 1/2 study interim results showed an immune
response comparable to patients who recovered from COVID-19 in
adults aged 18 to 49 years, but a low immune response in older
adults likely due to an insufficient concentration of the
antigen.
A recent challenge study in non-human primates performed with an
improved antigen formulation demonstrated that the vaccine
candidate could protect against lung pathology and lead to rapid
viral clearance from the nasal passages and lungs, within 2 to 4
days. These results increase the Companies confidence in the
capacity of the adjuvanted recombinant platform to deliver a highly
efficient vaccine for all adults.
Sanofi's recombinant technology and GSK's pandemic adjuvant are
established vaccine platforms that have proven successful against
influenza. The recombinant technology offers the advantages of
stability at temperatures used for routine vaccines, the ability to
generate high and sustained immune responses, and the potential to
prevent virus transmission.
"We care greatly about public health which is why we are
disappointed by the delay announced today, but all our decisions
are and will always be driven by science and data. We have
identified the path forward and remain confident and committed to
bringing a safe and efficacious COVID-19 vaccine. Following these
results and the latest encouraging new preclinical data, we will
now work to further optimise our candidate to achieve this goal, "
said Thomas Triomphe, Executive Vice President and Head of Sanofi
Pasteur. "No single pharma company can make it alone; the world
needs more than one vaccine to fight the pandemic."
Roger Connor, President of GSK Vaccines added: "The results of
the study are not as we hoped. Based on previous experience and
other collaborations, we are confident that GSK's pandemic adjuvant
system, when coupled with a COVID-19 antigen, can elicit a robust
immune response with an acceptable reactogenicity profile. It is
also clear that multiple vaccines will be needed to contain the
pandemic. Our aim now is to work closely with our partner Sanofi to
develop this vaccine, with an improved antigen formulation, for it
to make a meaningful contribution to preventing COVID-19."
The Companies plan a Phase 2b study expected to start in
February 2021 with support from the Biomedical Advanced Research
and Development Authority (BARDA), part of the HHS Office of the
Assistant Secretary for Preparedness and Response (ASPR) under
contract W15QKN-16-9-1002. The study will include a proposed
comparison with an authorised COVID-19 vaccine. If data are
positive, a global Phase 3 study could start in Q2 2021. Positive
results from this study would lead to regulatory submissions in the
second half of 2021, delaying the vaccine's potential availability
from mid-2021 to Q4 2021.
Sanofi and GSK adjuvanted recombinant-protein based vaccine
candidate was selected in July 2020 by U.S. government's Operation
Warp Speed in order to accelerate its development and
manufacturing.
The Companies have updated Governments and the European
Commission where a contractual commitment to purchase the vaccine
has been made.
Phase 1/2 study
The interim Phase 1/2 results showed a level of neutralizing
antibody titers after two doses comparable to sera from patients
who recovered from COVID-19, a balanced cellular response in adults
aged 18 to 49 years, but insufficient neutralising antibody titers
in adults over the age of 50. The candidate showed transient but
higher than expected levels of reactogenicity likely due to the
suboptimal antigen formulation, with no serious adverse events
related to the vaccine candidate. The most favourable results were
observed in the group which tested the highest antigen
concentration, combined with the GSK adjuvant, showing
neutralisation titers in 88% of participants. Seroconversion was
observed in 89.6% of the 18 to 49 age group; 85% in the >50 age
group; and 62.5% in the >60 age group.
The Phase 1/2 clinical study is a randomised, double blind and
placebo-controlled study designed to evaluate the safety,
reactogenicity and immunogenicity (immune response) of the COVID-19
vaccine candidate. A total of 440 healthy adults participated in
the study, across 10 investigational sites in the United States.
The participants received one or two doses of the vaccine
candidate, or placebo at 21 days apart.
Full results of the Phase 1/2 study will be published as soon as
all data are available, following peer-reviewed publication
process.
Latest preclinical results
A recent preclinical study using a highly virulent challenge in
non-human primates, showed high ability for the vaccine to protect
against lung pathology and reduce virus in the nose and lungs
within 2-4 days. Results from this pre-clinical study confirm
strong ability of the vaccine candidate to stop the replication of
the virus with an optimal antigen formulation.
These data are being prepared for submission to a peer-reviewed
publication.
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 working on
promising COVID-19 vaccines by providing access to our adjuvant
technology. In addition to work with Sanofi, collaborations with
Medicago and Clover Biopharmaceuticals on adjuvanted, protein-based
vaccine candidates are progressing into late-stage clinical trials.
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 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
are also assessing whether one of our potential new medicines,
otilimab -a monoclonal antibody - can help some COVID-19 patients
who experience an overreaction of their immune system, which can
lead to hospitalisation or death.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
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 28TU www.gsk.com/about-us U28T
.
GSK enquiries:
Media enquiries: Simon Steel +44 (0) 20 8047 (London)
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DC)
Analyst/Investor Sarah Elton-Farr +44 (0) 208 (London)
enquiries: 047 5194
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James Dodwell +44 (0) 20 8047 (London)
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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 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.
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