Valneva Confirms Clinical Trial and Regulatory Submission Timelines for its Inactivated COVID-19 Vaccine Candidate VLA2001
06 Janvier 2022 - 7:00AM
Saint Herblain (France), January
6, 2022 – Valneva SE
(Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company,
today confirms the previously communicated timelines of its
clinical trials and regulatory submissions for its inactivated,
adjuvanted COVID-19 vaccine candidate, VLA2001.
As announced in December 20211, the Company
commenced rolling submissions for initial approval of VLA2001 with
the European Medicines Agency, the UK MHRA and the Bahraini NHRA,
and is continuing to work closely with those authorities to
complete their review process following its positive Phase 3 trial
results2. Valneva continues to expect potential regulatory
approvals in the first quarter of 20221.
The Company also announced positive homologous
booster results at the end of December 20213. The data showed an
excellent immune response after a third dose of VLA2001
administered seven to eight months after the second dose of primary
vaccination. Valneva is also evaluating the sera from the boosted
participants for cross-neutralization against Variants of Concern,
including Omicron. In parallel, the Company is preparing to launch
a dedicated heterologous booster trial, which will evaluate a
VLA2001 booster shot provided at least six months after primary
vaccination with licensed COVID-19 vaccines or following natural
COVID-19 infection.
VLA2001 is also being evaluated in elderly and
adolescent volunteers. The Company expects to report topline data
for the elderly trial in the coming weeks.
Thomas
Lingelbach, Chief
Executive Officer of Valneva, commented,
“In recent weeks, we have been receiving even more messages every
day from people around the world who would like to be vaccinated
with an inactivated vaccine and want to know more about VLA2001. We
continue to believe that our inactivated vaccine candidate could be
an important component of the fight against COVID-19, and Valneva
remains fully committed to bringing VLA2001 to people who need it
as soon as we can. We look forward to sharing further data in due
course.”
Valneva announced in November 2021 that the
European Commission signed an agreement for the Company to supply
up to 60 million doses of VLA2001 over two years – including 24.3
million doses in 20224. Delivery of the vaccine is currently
expected to begin in April 2022, subject to approval by the
EMA.
About VLA2001VLA2001 is
currently the only whole virus, inactivated, adjuvanted vaccine
candidate in clinical trials against COVID-19 in Europe. It is
intended for active immunization of at-risk populations to prevent
carriage and symptomatic infection with COVID-19 during the ongoing
pandemic and potentially later for routine vaccination including
addressing new variants. VLA2001 may also be suited for boosting,
as repeat booster vaccinations have been shown to work well with
whole virus inactivated vaccines. VLA2001 is produced on Valneva’s
established Vero-cell platform, leveraging the manufacturing
technology for Valneva’s licensed Japanese encephalitis vaccine,
IXIARO®. 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
immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax
Technologies Corporation (Nasdaq: DVAX), is a component of the US
FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001’s manufacturing
process, which has already been upscaled to final industrial scale,
includes chemical inactivation to preserve the native structure of
the S-protein. VLA2001 is expected to conform with standard cold
chain requirements (2 to 8 degrees Celsius).
About Valneva SE
Valneva is a specialty vaccine company focused
on the development and commercialization of prophylactic vaccines
for infectious diseases with significant unmet medical need. The
Company takes a highly specialized and targeted approach to vaccine
development and then applies its deep understanding of vaccine
science to develop prophylactic vaccines addressing these diseases.
Valneva has leveraged its expertise and capabilities both to
successfully commercialize two vaccines and to rapidly advance a
broad range of vaccine candidates into and through the clinic,
including candidates against Lyme disease, the chikungunya virus
and COVID-19.
Media
& Investor ContactsLaëtitia Bachelot-FontaineVP Global
Communications & European Investor RelationsM +33 (0)6 4516
7099
laetitia.bachelot-fontaine@valneva.com |
Joshua
Drumm, Ph.D.VP Global Investor RelationsM +001 917 815
4520joshua.drumm@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 Confirms Initiation of Rolling Review with EMA and
Provides Updates on its COVID-19 Vaccine Program VLA20012 Valneva
Reports Positive Phase 3 Results for Inactivated, Adjuvanted
COVID-19 Vaccine Candidate VLA20013 Valneva Announces Positive
Homologous Booster Data for Inactivated, Adjuvanted COVID-19
Vaccine Candidate VLA20014 Valneva Signs Purchase Agreement with
European Commission for its Inactivated COVID-19 Vaccine
VLA2001
- 2022_01_06_VLA2001_Confirmation_PR_EN_Final
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