Valneva in Advanced Discussions with European Commission to Supply up to 60 Million Doses of Inactivated, Adjuvanted COVID-19...
12 Janvier 2021 - 12:02PM
Saint-Herblain (France), January 12,
2021 – Valneva SE, a specialty vaccine company focused on
prevention of infectious diseases with significant unmet medical
need, today announced it is in advanced discussions with the
European Commission (EC) for the supply of up to 60 million doses
of its COVID-19 vaccine, VLA2001. VLA2001 is currently the only
inactivated vaccine candidate in clinical trials against COVID-19
in Europe.
Valneva’s vaccine candidate is based on a proven
approach and will leverage the Company’s existing manufacturing
platform being used for its US Food and Drug Administration (FDA)
and European Medicines Agency (EMA) approved Japanese encephalitis
vaccine. VLA2001 entered Phase 1/2 clinical studies in December
20201 and Valneva expects to report initial safety and
immunogenicity data in April 2021. Upon analysis of the data,
Valneva will select the best dose and commence the second part of
the Phase 1/2 clinical development. If clinical development is
successful, an initial approval may be granted in the second half
of 2021.
Thomas Lingelbach, Chief Executive
Officer of Valneva, said, “Today’s announcement helps to
ensure that millions of Europeans potentially have access to a
proven and well-established inactivated vaccine approach, upon
approval of VLA2001. We are grateful to the European Commission for
their support and eager to partner with them to address the ongoing
pandemic. We are deeply committed to providing broad access to our
inactivated SARS-CoV-2 vaccine candidate and, as we proceed with
clinical development, we will simultaneously continue working with
partners, including the European Commission and the UK Government,
to help us reach that goal. We increasingly see wider recognition
that our vaccine will be one that the world cannot do without.”
In September 2020, Valneva announced a major
COVID-19 vaccine partnership with the UK government for the supply
of up to 190 million doses of its inactivated vaccine candidate,
VLA20012. Under the partnership agreement, if vaccine development
is successful, Valneva will provide the UK government with 60
million doses in the second half of 2021.
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
approximately 2 million reported deaths globally. It has been
declared a pandemic by the World Health Organization (WHO).
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 is expected to conform with standard
cold chain requirements (2 degrees to 8 degrees Celsius).
About VLA2001-201VLA2001-201 is
the first-in-human Phase 1/2 study evaluating 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 includes an
open-label dose-escalation phase and will be conducted as a
randomized, double-blind, multicenter study. On January 8th 2021, a
Data Safety Monitoring Board (DSMB) gave approval to progress into
the study’s full randomization phase. 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 Valneva SEValneva is a
specialty vaccine company focused on prevention of infectious
diseases with significant unmet medical need. The Company has
several vaccines in development including unique vaccines against
Lyme disease, COVID-19 and chikungunya. 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. Valneva has operations in
Austria, Sweden, the United Kingdom, France, Canada and the U.S.
with over 500 employees.
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 |
Forward-Looking StatementsThis
press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to the progress,
timing, design, data read-outs, anticipated results and completion
of clinical trials for VLA2001. In addition, even if the actual
results or development of Valneva are consistent with the
forward-looking statements contained in this press release, those
results or developments of Valneva may not be indicative of future
results. In some cases, you can identify forward-looking statements
by words such as "could," "should," "may," "expects,"
"anticipates," "believes," "intends," "estimates," "aims,"
"targets," or similar words. These forward-looking statements are
based on the current expectations of Valneva as of the date of this
press release and are subject to a number of known and unknown
risks and uncertainties and other factors that may cause actual
results, performance or achievements to be materially different
from any future results, performance or achievement expressed or
implied by these forward-looking statements. In particular, the
expectations of Valneva could be affected by, among other things,
uncertainties involved in the development and manufacture of
vaccines, unexpected clinical trial results, unexpected regulatory
actions or delays, competition in general, currency fluctuations,
the impact of the global and European credit crisis, the ability to
obtain or maintain patent or other proprietary intellectual
property protection and the impact of the COVID-19 pandemic. In
light of these risks and uncertainties, there can be no assurance
that the forward-looking statements made during this presentation
will in fact be realized. Valneva is providing the information in
this press release as of the date hereof and disclaims any
intention or obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events, or otherwise.
1 Valneva Initiates Phase 1/2 Clinical Study of Inactivated,
Adjuvanted COVID-19 Vaccine
2 Valneva Announces Major COVID-19 Vaccine Partnership with U.K.
Government
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