Valneva Continues Expansion of Clinical Trials of its Inactivated COVID-19 Vaccine Candidate VLA2001
23 Septiembre 2021 - 12:00AM
Valneva Continues Expansion of Clinical Trials of its Inactivated
COVID-19 Vaccine Candidate VLA2001
- Commences
recruitment of
Adolescents into
Phase 3 trial
“Cov-Compare”
-
Enrolls
participants in the Phase 1/2
Booster Trial
Saint-Herblain
(France),
September 23,
2021 – Valneva SE, (Nasdaq: VALN; Euronext Paris:
VLA) a specialty vaccine company, today announced that it has
commenced recruitment of adolescents in its pivotal Phase 3
Clinical Trial (VLA2001-301, “Cov-Compare”) for its inactivated
COVID-19 vaccine candidate VLA2001 in the United Kingdom. Topline
results from the pivotal Cov-Compare trial are expected early in
the fourth quarter of 2021 and are intended to form the basis for
potential regulatory approval in adults. The Company has also
started to provide boosters to volunteers in its Phase 1/2
VLA2001-201 trial. This planned expansion of VLA2001 clinical
trials will support future approval in further age groups, in
addition to adults.
Recruitment of adolescents, aged 12 to 17 years,
has commenced in the United Kingdom as part of Valneva’s pivotal
Cov-Compare Phase 3 trial (VLA2001-301). An initial cohort of
adolescents will be enrolled in an open label, non-randomized
format. Subject to safety review, remaining participants will be
randomized to receive two doses of either VLA2001 or a placebo 28
days apart, followed by a booster dose seven months after enrolling
into the study. Approximately 660 participants will be recruited
for this trial. Participants randomized to the placebo arm will
have the opportunity to receive a course of VLA2001 following the
initial safety assessment. A further expansion of the study to
include volunteers younger than 12 years old is also envisaged,
subject to data from the adolescent group.
Valneva has also commenced booster vaccinations
as a continuation of the Phase 1/2 VLA2001-201 trial for which the
Company reported positive topline data in April 20211. The booster
shot will be provided to each volunteer six months after initial
vaccination.
Valneva is conducting several clinical trials of
VLA2001. In addition to Cov-Compare and VLA2001-201, VLA2001 is
being evaluated in elderly volunteers in study VLA2001-304 in New
Zealand as well as in a small, policy-led trial sponsored by
University Hospital Southampton NHS Foundation Trust which is not
part of Valneva’s regulatory package.
Valneva continues discussions with the European
Commission regarding a potential VLA2001 supply contract. The
Company is also actively pursuing opportunities to make VLA2001
available to other customers, subject to positive Cov-Compare data
and regulatory approval.
Thomas
Lingelbach, Chief Executive Officer of
Valneva, commented, “Our teams at Valneva remain fully
committed to carry out VLA2001’s development plan and bring our
inactivated vaccine to all patient groups who could benefit. We
continue to receive messages on a daily basis from people across
the world who are waiting for an inactivated vaccine so we continue
to believe that our differentiated vaccine candidate could
contribute to the ongoing fight against the COVID-19 pandemic.
We’re confident that many countries, and regulators, will want to
have the opportunity to consider our inactivated COVID-19
vaccine.”
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 using
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 SEValneva 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, the cancellation of existing contracts,
including but not limited to the HMG Supply Agreement, and the
impact of the COVID-19 pandemic, the occurrence of any of which
could substantially harm Valneva’s business, financial condition,
prospects and results of operations. 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 Reports Positive Phase 1/2 Data for Its Inactivated,
Adjuvanted COVID-19 Vaccine Candidate, VLA2001
- 2021_09_22_Clinical_Update_PR_EN_Final
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