TIDMGSK
RNS Number : 1086K
GlaxoSmithKline PLC
31 August 2021
Issued: 31 August 2021, London, UK and Seoul, Republic of
Korea
SK bioscience and GSK start Phase 3 trial of adjuvanted COVID-19
vaccine candidate
-- Advance to Phase 3 follows positive interim Phase 1/2 immunogenicity and safety data
-- Global clinical trial will evaluate vaccine candidate GBP510
against the AZ/Oxford COVID-19 vaccine
-- Aim is for global supply through the COVAX facility in the
first half of 2022, subject to data and regulatory review
SK bioscience (SK) and GlaxoSmithKline plc (GSK) today announced
the initiation of a Phase 3 clinical study of SK's COVID-19 vaccine
candidate, GBP510, in combination with GSK's pandemic adjuvant
following positive interim Phase 1/2 results.
The randomised, active-controlled global trial will enrol around
4,000 participants from a range of countries and will aim to
evaluate GBP510's safety and immunogenicity compared to an active
comparator - the AstraZeneca/Oxford University COVID-19 vaccine.
The study will be one of the first global Phase 3 trials to compare
two different COVID-19 vaccine candidates.
Jaeyong Ahn, CEO, SK bioscience said, "We are grateful that we
were able to advance to the Phase 3 study with the unprecedented
support of global initiatives, including GSK, Coalition for
Epidemic Preparedness Initiative (CEPI), and the Bill & Melinda
Gates Foundation (BMGF). Taking this important step towards
overcoming the global pandemic situation, SK and GSK will bring our
technical expertise together for the development of an adjuvanted
protein-based vaccine candidate, GBP510."
Thomas Breuer, Chief Global Health Officer, GSK said, "While
many countries have made good progress with vaccination, there
remains a need for accessible and affordable COVID-19 vaccines to
ensure equitable access and to protect people across the world. We
are pleased to contribute with GSK's pandemic adjuvant and to be
working with SK to deliver the vaccine at scale via COVAX if it is
approved."
The advance to Phase 3 study follows positive interim Phase 1/2
data which showed that all participants who received the adjuvanted
vaccine candidate developed strong neutralizing antibody responses,
demonstrating a 100% seroconversion rate. Neutralizing antibody
titres were between five and a maximum of eight times higher
compared to sera from people recovered from COVID-19. No safety
concerns have been identified to date in this ongoing study.
GBP510 is a self-assembl ed nanoparticle vaccine candidate
targeting the receptor binding domain of the SARS-CoV-2 Spike
protein, combined with GSK's pandemic adjuvant. The antigen is
being developed by SK in collaboration with the Institute for
Protein Design (IPD) at the University of Washington with support
from BMGF and CEPI as part of the 'Wave 2' vaccine investment
project to develop more accessible and affordable COVID-19
vaccines.
Results from the Phase 3 study are expected in the first half of
2022 after which, subject to positive results and regulatory
approval, the vaccine is expected to be supplied at scale worldwide
through the COVAX facility.
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 pandemic adjuvant. As well as
working with SK, we are collaborating with Sanofi and Medicago to
develop adjuvanted, protein-based vaccine candidates, and all are
now in Phase 3 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 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.
Sotrovimab, a monoclonal antibody for the early treatment of
COVID-19 in adults at high risk of hospitalisation, received
Emergency Use Authorization (EUA) from the US Food and Drug
Administration (FDA) in May 2021. 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 SK bioscience
SK bioscience is an innovative biopharmaceutical company
specialized in the vaccine area. By leveraging strengths in
cutting-edge vaccine development technologies, we have been
dedicated to human health from prevention to cure across the globe.
With the collaboration of domestic and international governments,
regulatory agencies, healthcare providers and medical experts, our
colleagues are passionately committed to provide affordable and
high-quality vaccines to those who need them and improve the health
care environment.
For more information, please visit
https://www.skbioscience.co.kr/en/main
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 .
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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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