Valneva Completes Recruitment of Elderly Participants in Phase 3 Trial of its Inactivated COVID-19 Vaccine
14 Septiembre 2021 - 12:00AM
Valneva Completes Recruitment of Elderly Participants in Phase 3
Trial of its Inactivated COVID-19 Vaccine
Saint-Herblain
(France),
September 14,
2021 – Valneva SE, a specialty vaccine company, today
announced that it has completed recruitment of the initial cohort
of elderly participants in Valneva’s Phase 3 trial, VLA2001-304, of
its inactivated COVID-19 vaccine candidate, VLA2001.
300 volunteers aged 56 years and older have been
recruited in New Zealand into the VLA2001-304 trial with the
objective to generate further safety and immunogenicity data for
this age group. The cohort size has been increased to 300, from
150, in consultation with the European Medicines Agency (“EMA”).
Topline data from this cohort will read out in early 2022, and it
is expected that the data will support additional regulatory
submissions.
Juan Carlos Jaramillo, M.D., Chief
Medical Officer of Valneva, commented, “We initiated this
trial approximately a month ago, so we are extremely pleased to
achieve this important milestone in such a short period of time. We
believe that our differentiated vaccine candidate can make a major
contribution to the ongoing fight against the COVID-19
pandemic.”
VLA2001 is currently the only inactivated
vaccine candidate in clinical trials against COVID-19 in Europe. In
parallel to the VLA2001-304 trial in New Zealand, VLA2001 is
currently being studied in the United Kingdom (UK) in a pivotal
Phase 3 trial, “Cov-Compare” (VLA2001-301), for which top-line
results are currently expected early in the fourth quarter 2021.
Valneva has commenced rolling submission for conditional approval
with the UK’s Medicines and Healthcare products Regulatory Agency
(MHRA).
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
VLA2001-304Trial VLA2001-304 is expected
to enroll two cohorts. Cohort 1 includes 300 volunteers aged 56
years and older in an open-label manner in order to generate safety
and immunogenicity data for VLA2001 in this age group. Cohort 2 of
the trial is expected to 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, based on a variant
strain to be confirmed. In both cohorts, vaccinations will be
administered in a two-dose immunization schedule 28 days apart. The
trial will be conducted at approximately 10 trial sites in New
Zealand. 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,
COVID-19 and the chikungunya virus.
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_09_14_VLA2001-304_Recruitment_Completion_PR_EN_Final
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