Saint-Herblain (France), December 16, 2020 –
Valneva SE, a specialty vaccine company focused on prevention
against diseases with major unmet needs, today announced the
initiation of a Phase 1/2 clinical study for its inactivated,
adjuvanted COVID-19 vaccine candidate, VLA2001.
VLA2001 leverages the manufacturing platform of
Valneva’s licensed Japanese encephalitis vaccine, IXIARO® and is
the first publicly announced inactivated vaccine against COVID-19
to commence clinical development in Europe.
The VLA2001-201 study is a randomized, double
blind and placebo-controlled trial evaluating the safety and
immunogenicity for three dose levels in approximately 150 healthy
adults.
The study will be conducted in study sites
across the United Kingdom and is supported by the National
Institute for Health Research (NIHR).
The primary endpoint read-out will be two weeks
after completion of the two-dose primary immunization (day 0, 21).
Subject to analysis of this data, including the selection of the
optimal dose currently expected in the early second quarter of
2021, additional trials are expected to commence immediately
thereafter.
The Company currently plans to include more than
4,000 participants in additional trials, which it believes could
support an initial regulatory approval as soon as the fourth
quarter of 2021.
Alok Sharma, UK
Secretary of State for Business, Energy and Industrial
Strategy, said, “As we take the monumental steps in
rolling out the first COVID-19 vaccine, we must remember that we
need to have a range of vaccines available to protect the British
public now and long into the future. Today, we have more welcome
news that life-saving clinical trials will begin across the country
to test the safety and effectiveness of Valneva’s vaccine, which is
being clinically developed right here in the UK. Having visited
Valneva’s state-of-the art facility in the summer, I have seen
first-hand the incredible work our scientists and researchers are
doing to develop this vaccine. Thanks to significant investment
from the UK government, we are doing all we can to ensure our
country has the capabilities in place to produce hundreds of
millions of doses of this vaccine for the UK, and for those around
the world.”
Thomas Lingelbach, Chief Executive
Officer of Valneva, added, “Our teams have been working
extremely hard to develop our differentiated vaccine candidate and
I would like to thank them, as well as the UK government, for their
dedication and support. While conducting our first clinical trials,
we are already ramping-up our manufacturing capacities and
commencing production at full-scale so that we can make the vaccine
widely available across the world assuming the vaccine is safe and
effective.”
Adam Finn, Chief
investigator for the VLA 2001-201 program,
Professor of Paediatrics at the University of Bristol and
Consultant at the Bristol Royal Hospital for Children
said, “I’m very pleased and proud to be leading the clinical trials
effort to bring this vaccine forward in the UK working alongside a
very strong team across several National Institute for Health
Research NHS sites. The effort to produce vaccines to prevent
COVID-19 and to limit its spread within populations has included
several very new approaches, but there are tried and tested
approaches to developing highly effective and safe vaccines that we
can also use. Growing the whole virus and then inactivating it to
make a vaccine is an approach first developed in the 1950s and has
contributed to disease prevention over many decades. We expect this
inactivated vaccine containing two adjuvants could generate a
broader immune response.”
In September 2020, Valneva announced a major
COVID-19 vaccine partnership with the U.K. government. Under the
agreement, if vaccine development is successful, Valneva will
provide the UK government with 60 million doses in the second half
of 2021 and UK government has options over provision of a further
130 million doses from 2022-2025. UK government is also investing
up-front in the scale up and development of the vaccine, with the
investment being recouped against the vaccine supply.
About the Novel Coronavirus SARS-CoV-2
and COVID-19 DiseaseSARS-CoV-2 is a new coronavirus
identified in late 2019 and belongs to a family of enveloped RNA
viruses that include MERS and SARS, both of which caused serious
human infections of the respiratory system. The virus, which causes
a disease named COVID-19, has never before been found in humans.
Since this outbreak was first reported, the virus has caused over
1.6 million reported deaths globally. It has been declared a
pandemic by the World Health Organization (WHO).
About VLA2001-201VLA2001-201 is
the first-in-human Phase 1/2 study that will evaluate three dose
levels of VLA2001 (low, medium, high) for safety, tolerability and
immunogenicity in a two-dose schedule with intra muscular
vaccinations three weeks apart. Overall, 150 healthy young adults
aged 18 to 55 years will be recruited. The study will start with an
open-label dose-escalation phase. Following review of safety data
by an independent Data Safety Monitoring Board (DSMB), the study
will be conducted as a randomized, double-blind, multicenter study.
VLA2001-201 is conducted in two parts: Part A (Day 1 to Day 36) and
Part B (Day 37 to Day 208). Following an evaluation of Part A data
(i.e., data up to Day 36) from the present study, further clinical
studies may be initiated.
About VLA2001VLA2001 is
Valneva’s vaccine candidate against the SARS-CoV-2 virus. VLA2001
consists of inactivated whole virus particles of SARS-CoV-2 with
high S-protein density, in combination with two adjuvants, alum and
CpG 1018. This adjuvant combination has consistently induced higher
antibody levels in preclinical experiments than alum-only
formulations and shown a shift of the cellular immune response
towards Th1. VLA2001 is produced on Valneva’s established Vero-cell
platform, leveraging the manufacturing technology for Valneva’s
licensed Japanese Encephalitis Vaccine, IXIARO®. The process, which
has already been upscaled to final industrial scale, includes
inactivation with BPL to preserve the native structure of the
S-protein. CpG 1018 is a component of the US FDA-approved
HEPLISAV-B® vaccine.VLA2001 vaccine is expected to conform with
standard cold chain requirements (2 degrees to 8 degrees
centigrade).
About Valneva SEValneva is a
specialty vaccine company focused on prevention against diseases
with major unmet needs. Valneva’s portfolio includes two commercial
vaccines for travelers: IXIARO®/JESPECT® indicated for the
prevention of Japanese encephalitis and DUKORAL® indicated for the
prevention of cholera and, in some countries, prevention of
diarrhea caused by ETEC. The Company has various vaccines in
development including unique vaccines against Lyme disease,
chikungunya and COVID-19. Valneva has operations in Austria,
Sweden, the United Kingdom, France, Canada and the US with over 500
employees. For more information, visit www.valneva.com and
follow the Company on LinkedIn.
Valneva Investor and Media
ContactsLaetitia Bachelot-FontaineDirector Investor
Relations & Corporate CommunicationsM +33 (0)6 4516
7099investors@valneva.com |
Teresa PinzolitsCorporate Communications SpecialistT
+43 (0)1 20620 1116communications@valneva.com |
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Valneva Forward-Looking Statements
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forward-looking statements relating to the business of Valneva,
including with respect to the progress, timing and completion of
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