Valneva Initiates Further Phase 3 Clinical Trial for its COVID-19 Vaccine Candidate
11 August 2021 - 5:45PM
Saint-Herblain (France), August 11th,
2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company focused on the development and
commercialization of prophylactic vaccines for infectious diseases
with significant unmet medical need, today announced the initiation
of a further Phase 3 trial (VLA2001-304) for its inactivated,
adjuvanted COVID-19 vaccine candidate, VLA2001.
VLA2001-304 aims to generate data in the elderly
and is also designed to potentially enable variant-bridging through
immune-comparability. Data from this study are expected to
complement ongoing clinical trials and support additional
regulatory submissions.
VLA2001-304, which will be conducted in New
Zealand, will recruit approximately 150 participants aged 56 years
and older (Cohort 1) with the aim of generating additional safety
and immunogenicity data in this age group following vaccination
with VLA2001 (two doses 28 days apart).
Juan Carlos Jaramillo M.D., Chief
Medical Officer of Valneva, said, “The fight against
COVID-19 continues and it’s extremely important that we continue to
gather as much data as possible in all age groups across the
population. Everyone should have access to technology best suited
to protect them against this virus. We have also been working on
Variants of Concern as part of our continued efforts to stay ahead
of the virus causing COVID-19 especially since we believe that our
inactivated, whole-virus platform will be adaptable across
variants. Hence we are extremely pleased to be able to invest in
this very important additional clinical trial”.
In June 2021, Valneva announced that it had
completed recruitment for VLA2001’s pivotal Phase 3 trial
“Cov-Compare” (VLA2001-301) with over 4,000 randomized
participants. Valneva plans to make regulatory submissions for
initial approval in the fourth quarter of 2021, subject to
successful Cov-Compare data.
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. The manufacturing
process for VLA2001, 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 degrees to 8 degrees
Celsius).
About VLA2001-304Trial
VLA2001-304 will enroll two cohorts. Cohort 1 will include
approximately 150 volunteers aged 56 years and older in an
open-label manner in order to generate safety and immunogenicity
data for this age group. Cohort 2 will include approximately 600
volunteers aged 12 years and older in order to compare
immunogenicity data of Valneva’s original COVID-19 vaccine
candidate, VLA2001, to an additional COVID-19 vaccine candidate,
VLA2101, to be based on a variant strain to be confirmed. In both
cohorts, vaccinations will be administered in a 2-dose immunization
schedule 28 days apart. The trial will be conducted at
approximately 10 trial sites in New Zealand.
https://www.clinicaltrials.gov/ct2/show/NCT04956224
ClinicalTrials.gov Identifier: NCT04956224
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, beginning
with the identification of deadly and debilitating infectious
diseases that lack a prophylactic vaccine solution and for which
there are limited therapeutic treatment options. It then applies
its deep understanding of vaccine science, including its expertise
across multiple vaccine modalities, as well as its established
vaccine development capabilities, to develop prophylactic vaccines
to address these diseases. The Company 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.
- 2021_08_11_VLA2001_304_Initiation_PR_EN