Valneva Successfully Completes Lot-to-Lot Consistency Trial for its
Single-Shot Chikungunya Vaccine Candidate
Saint Herblain
(France), May
25,
2022 – Valneva SE (Nasdaq: VALN;
Euronext Paris: VLA), a specialty vaccine company, today announced
the successful completion of the lot-to-lot Phase 3 trial of its
single-shot chikungunya vaccine candidate, VLA1553. The final
analysis included six-month follow-up data and confirmed the
topline results reported in December 2021.
The VLA1553-302 trial met its primary endpoint,
demonstrating that three consecutively manufactured vaccine lots
elicited equivalent immune responses measured by neutralizing
antibody titer GMT ratios on Day 29 after vaccination.
The trial included 408 participants aged 18 to
45 years. The safety profile shown in study VLA1553-302 was similar
to the Phase 3 trial, VLA1553-3011. With a 96.0% seroprotection
rate at Day 180, the immunogenicity profile from study VLA1553-301
was also confirmed.
Juan Carlos Jaramillo,
Chief Medical Officer of Valneva commented, “We are
extremely pleased that the final lot-to lot data confirmed the
previously reported topline results. We have now all necessary
clinical data to support submission with the US Food and Drug
Administration (FDA), which we plan to start later this year.
Chikungunya is a major, growing and unmet public health threat, yet
no vaccine or specific treatment is currently available to prevent
this debilitating disease. We will continue to work assiduously to
bring VLA1553 to market as soon as possible.”
Valneva’s chikungunya program was awarded
Breakthrough Therapy Designation by the US FDA in July 2021. This
milestone followed the US FDA’s Fast Track designation and the
European Medicines Agency (EMA)’s PRIME designation which the
Company received in December 2018 and in October 2020,
respectively. The sponsor of the first chikungunya vaccine
Biologics License Application (BLA) to be approved in the U.S. will
be eligible to receive a Priority Review Voucher (PRV) 2.
About ChikungunyaChikungunya is
a mosquito-borne viral disease caused by the chikungunya virus
(CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
Infection leads to symptomatic disease in 72-92% of humans after 4
to 7 days following the mosquito bite. While mortality with CHIKV
is low, morbidity is high. Clinical symptoms include acute onset of
fever, debilitating joint and muscle pain, headache, nausea, rash
and chronic arthralgia. Chikungunya virus often causes sudden large
outbreaks with high attack rates, affecting one-third to
three-quarters of the population in areas where the virus is
circulating. The high risk areas of infection for travelers are
places where chikungunya virus-carrying mosquitos are endemic,
including the Americas, parts of Africa, and Southeast Asia, and
the virus has spread to more than 100 countries. As of September
2020, there were more than 3 million reported cases in the
Americas3 and the economic impact is considered to be significant.
The medical and economic burden is expected to grow as the CHIKV
primary mosquito vectors continue to spread geographically. There
are no preventive vaccines or effective treatments available and,
as such, chikungunya is considered to be a major public health
threat.
About VLA1553VLA1553 is a
live-attenuated, single dose investigational vaccine candidate
designed to target the chikungunya virus. It has been designed by
deleting a part of the chikungunya virus genome. In March 2022,
Valneva announced successful completion of the Phase 3 pivotal
trial of VLA15534. The final six-month analysis confirmed the very
high level of seroprotection reported from this trial in August
2021. In this double-blind, multi-center, randomized Phase 3
clinical trial, 4,115 participants aged 18 years and above were
randomized 3:1 into two groups to receive either 0.5mL of VLA1553
or a placebo. The trial met its primary endpoint, inducing
protective CHIKV neutralizing antibody titers in 98.9% of
participants 28 days after receiving a single shot (264 of 268
subjects from the per-protocol subgroup tested for immunogenicity,
95% CI: 96.2-99.6). The seroprotective titer was agreed with the
FDA to serve as a surrogate of protection that can be utilized in a
submission for approval of VLA1553 under the accelerated approval
pathway. VLA1553 was highly immunogenic, with a GMT of
approximately 3,270.VLA1553 was generally well tolerated among the
3,082 subjects evaluated for safety. An independent Data Safety
Monitoring Board, or DSMB, continuously monitored the study and
identified no safety concerns. Solicited adverse events were
observed, the majority of which were mild or moderate and resolved
within 3 days. Additionally, VLA1553 was shown in the Phase 3
pivotal trial to be highly immunogenic in elderly study
participants, who achieved equally high seroprotection rates and
neutralizing antibody titers as younger adults, as well as an
equally good safety profile.VLA1553 would expand Valneva’s existing
travel vaccine portfolio and as such, Valneva intends to
commercialize this vaccine, if approved, leveraging its existing
manufacturing and commercial operations. The global market for
chikungunya vaccines is estimated to exceed $500 million annually
by 20325.To make VLA1553 more accessible to Low and Middle Income
Countries (LMIC), Valneva and Instituto Butantan in Brazil signed
an agreement in January 2021 for the development, manufacturing and
marketing of VLA15536. The collaboration falls within the framework
of the agreement signed between CEPI and Valneva in July 20197,
which provides funding of up to $23.4 million with support from the
European Union’s Horizon 2020 program.
About Phase 3 study
VLA1553-302The VLA1553-302 clinical
lot-to-lot consistency study is a prospective, multicenter,
randomized, pivotal Phase 3 study including 408 participants aged
18 to 45 years. Lyophilized VLA1553 were administered as a single
intramuscular immunization. Equivalence of immune responses was
determined based on neutralizing antibody titers. The primary
objective of the study was to evaluate a pair-wise comparison of
the 95% Confidence Interval (CI) on the ratio of GMTs on Day 29
after vaccination in the three vaccine lots. The two-sided 95% CI
on the GMT ratio should be within 0.67 and 1.5 in order to
demonstrate consistency.Study volunteers were followed for six
months after vaccination. Additional information, including a
detailed description of the study design, eligibility criteria and
investigator sites, is available at ClinicalTrials.gov (Identifier:
NCT04786444).
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. Valneva has leveraged its expertise and
capabilities to successfully commercialize two wholly owned
vaccines and rapidly advance multiple vaccine candidates into
late-stage clinical development, including candidates against Lyme
disease (partnered with Pfizer), the chikungunya virus and
COVID-19.
Media
& Investors ContactsLaëtitia Bachelot-FontaineVP
Global Communications & European Investor RelationsM +33 (0)6
4516 7099
laetitia.bachelot-fontaine@valneva.com |
Joshua
Drumm, PhDVP Global Investor RelationsM +001 917 815
4520joshua.drumm@valneva.com |
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Forward-Looking StatementsThis
press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to the progress,
timing, results and completion of research, development and
clinical trials for investigational product candidates and
estimates for future performance. 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 sustained in the
future. 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 largely 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, and the ability to obtain or maintain patent or other
proprietary intellectual property protection. Success in
preclinical studies or earlier clinical trials may not be
indicative of results in future clinical trials. 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 these
materials as of this press release, and disclaim 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 Successfully Completes Pivotal Phase 3 Trial of
Single-Shot Chikungunya Vaccine Candidate – Valneva2
https://priorityreviewvoucher.org/3 PAHO/WHO data: Number of
reported cases of chikungunya fever in the Americas.
https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html.
Last accessed 13 Oct 2020.4 Valneva Successfully Completes Pivotal
Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate –
Valneva5 VacZine Analytics Chikungunya virus vaccines Global demand
analysis. February 20206 Valneva and Instituto Butantan Sign Final
Agreement on Single-Shot Chikungunya Vaccine for Low and Middle
Income Countries7 CEPI awards up to $23.4 million to Valneva for
late-stage development of a single-dose Chikungunya vaccine
- 2022_05_25_VLA1553_Final_L2L_PR_EN
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