Valneva Announces Positive Lot-to-Lot Consistency Trial Results for
its Single-Shot Chikungunya Vaccine Candidate
Saint Herblain
(France),
December 21,
2021 – Valneva SE (Nasdaq: VALN; Euronext Paris:
VLA), a specialty vaccine company, today announced positive topline
results from the lot-to-lot Phase 3 trial of its single-shot
chikungunya vaccine candidate, VLA1553. 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.
Lot-to-lot trials demonstrate manufacturing
consistency, one of the standard requirements for vaccine
licensure. The trial, which included 408 participants aged 18 to 45
years, confirmed the excellent immunogenicity profile demonstrated
in the pivotal Phase 3 trial, VLA1553-301. All three lots were
equally well tolerated and the safety profile was consistent with
results in the pivotal Phase 3 trial. Study VLA1553-302 therefore
confirmed clinical equivalence as well as manufacturing consistency
of the three lots.
Juan Carlos Jaramillo,
Chief Medical Officer of Valneva commented, “We are
extremely pleased with these lot-to-lot Phase 3 data, which come in
addition to the compelling pivotal Phase 3 results we reported in
August. The lot-to-lot data will be part of our submission with the
US Food and Drug Administration (FDA), which we plan to start in
2022. 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.”
The lot-to-lot trial will continue towards final
six-month analysis with final trial results expected in the second
quarter of 2022.
Valneva’s chikugunya program was awarded
Breakthrough Therapy Designation by the US FDA in July 2021. This
new 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) 1.
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. As of
September 2020, there were more than 3 million reported cases in
the Americas2 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 vaccine candidate targeting the
chikungunya virus, which has spread to more than 100 countries. It
has been designed by deleting a part of the chikungunya virus
genome. In August 2021, Valneva reported positive topline results
for pivotal Phase 3 clinical trial, VLA1553-301. 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 98.5% 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.
The majority of solicited adverse events were mild or moderate and
resolved within 3 days. Additionally, VLA1553 was 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.VLA1553-301 will continue towards final analysis including
the 6-month safety data. The Company expects to report final trial
results in early 2022.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 20323.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 VLA15534. The collaboration falls within the framework
of the agreement signed between CEPI and Valneva in July 20195,
which provides funding of up to $23.4 million with support from the
European Union’s Horizon 2020 program.
About Phase 3 study
VLA1553-302VLA1553-302 clinical
lot-to-lot consistency Phase 3 study is a prospective, multicenter,
randomized, pivotal Phase 3 study including 408 participants aged
18 to 45 years. Lyophilized VLA1553 are administered as a single
intramuscular immunization. Equivalence of immune responses will be
determined based on neutralizing antibody titers. The primary
objective of the study is 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 will be 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 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 https://priorityreviewvoucher.org/2 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 2020.3 VacZine Analytics Chikungunya virus
vaccines Global demand analysis. February 20204 Valneva and
Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya
Vaccine for Low and Middle Income Countries5 CEPI awards up to
$23.4 million to Valneva for late-stage development of a
single-dose Chikungunya vaccine
- 2021_12_21_VLA1553_L2L_Phase3_Results_PR_EN_Final
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