- Primary endpoint
met with 99% seroresponse rate 12 months after single-dose
vaccination
- Antibody levels remained stable from month 6 to month 12
- No safety concern identified during
follow-up, confirming the safety profile observed in earlier
studies
- Valneva currently on track to complete rolling submission for
Biologics License Application (BLA) with U.S. Food and Drug
Administration (FDA) by end of 2022
Saint-Herblain
(France),
December 5,
2022 – Valneva SE (Nasdaq: VALN; Euronext Paris:
VLA), a specialty vaccine company, today reported positive antibody
persistence data twelve months after vaccination with a single dose
of its chikungunya vaccine candidate, VLA1553.
Following positive immunogenicity and safety
data for Phase 3 study VLA1553-301 in March 20221, Valneva set up a
dedicated antibody persistence trial (VLA1553-303) to monitor a
subset of participants for a period of at least five years and
confirm the anticipated long-term durability of the antibody
response after a single vaccination.
The antibody persistence trial enrolled 363
healthy adult participants and followed them from month 6 after
vaccination to month 12. 99% of participants retained neutralizing
antibody titers above the seroresponse threshold of 1502 12 months
after the single-dose vaccination. These antibody levels confirm
the antibody persistence profile observed in an earlier study3. The
antibody persistence was similar in older adults aged ≥65 years,
who retained neutralizing antibody titers comparable to younger
adults throughout the follow-up. These results follow completion of
the pivotal study VLA1553-301, for which a seroresponse rate of 96%
six months after vaccination1 was reported. The study will continue
to monitor antibody persistence on an annual basis.
No safety concerns were identified for the
duration of the follow-up study, confirming the safety profile
observed in previous studies.
Juan Carlos Jaramillo M.D., Chief
Medical Officer of Valneva, said, “We are excited about
these twelve-month data which are in line with what we saw from our
previous read out at month 6, and strengthen the possibilities of
inducing a long-lasting antibody response with our chikungunya
vaccine candidate. We are looking forward to completing the BLA
rolling submission to the FDA and potentially to changing people’s
lives. If our investigational vaccine is approved, we are confident
that it can help address this major, growing and unmet public
health threat.”
Valneva expects to finalize its BLA submission
with the FDA by the end of 2022. Once completed, and if the FDA
accepts the filing, the FDA will determine priority review
eligibility along with the action due date upon which it will
complete its evaluation. The program received FDA Fast Track and
Breakthrough Therapy designations in 2018 and 2021, respectively.
VLA1553 was also granted PRIority MEdicine (PRIME) designation by
the EMA in 2020. Valneva currently plans to make additional
regulatory submissions for VLA1553 in 2023. Valneva also initiated
a Phase 3 trial in adolescents conducted in Brazil by Instituto
Butantan to support the label extension in this age group following
a potential initial regulatory approval.
About ChikungunyaChikungunya is
a mosquito-borne viral disease caused by the chikungunya virus
(CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
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. There are no
preventive vaccines or effective treatments available and, as such,
chikungunya is considered to be a major public health threat. As of
September 2020, there were more than 3 million reported cases in
the Americas4 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. Infection leads to symptomatic disease in up to 97%
of humans after three to seven 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. It is
estimated that over three quarters of the world’s population live
in areas at-risk of CHIKV transmission5. High risk areas of
infection are places where chikungunya virus-carrying mosquitos are
currently endemic, including the Americas, parts of Africa, and
Southeast Asia.
About VLA1553VLA1553 is a
live-attenuated, single dose vaccine candidate targeting the
chikungunya virus, which has spread to over 100 countries. It has
been designed by deleting a part of the chikungunya virus genome.
VLA1553 would expand Valneva’s existing commercial vaccines
portfolio and as such, Valneva intends to commercialize this
vaccine, if approved, leveraging its existing manufacturing and
commercial operations. The global market for vaccines against
chikungunya is estimated to exceed $500 million annually by
20326.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 VLA15537. The collaboration falls within the framework
of the agreement signed between CEPI and Valneva in July 20198,
which provides funding of up to $23.4 million with support from the
European Union’s Horizon 2020 program.
About Phase 3 trial
VLA1553-303VLA1553-303 is a single-arm,
open label Phase 3 trial evaluating antibody persistence in 363
participants aged 18 years or above who were immunized with VLA1553
during the pivotal trial VLA1553-301. The primary objective of the
trial is to evaluate the persistence of antibodies annually from 1
to 5 years after the single immunization with VLA1553. Study
VLA1553-303 collected long-term safety by following-up any Adverse
Event of Special Interest (AESI) from the preceding study and
collecting new-onset SAE. When participants joined the follow-up
study, no AESI was ongoing.Additional information, including a
detailed description of the trial design, eligibility criteria and
investigator sites, is available at ClinicalTrials.gov (Identifier:
NCT04546724).
About Valneva SEValneva is a
specialty vaccine company focused on the development, production
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 commercialize
three vaccines and to rapidly advance a broad range of vaccine
candidates into and through the clinic, including candidates
against Lyme disease and the chikungunya virus.
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 |
|
|
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, clinical
trials, and regulatory review of VLA1553. 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 A neutralizing
antibody titer of ≥150 determined by µPRNT50, i.e. the antibody
level agreed with regulators as endpoint under the accelerated
approval pathway.3 Valneva Reports Excellent Final Phase 1 Results
for its Chikungunya Vaccine Candidate, Confirms Plans - Valneva4
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 2020.5 CDC 2022, Puntasecca CJ 20216 VacZine
Analytics Chikungunya virus vaccines Global demand analysis.
February 20207 Valneva and Instituto Butantan Sign Final Agreement
on Single-Shot Chikungunya Vaccine for Low and Middle Income
Countries8 CEPI awards up to $23.4 million to Valneva for
late-stage development of a single-dose Chikungunya vaccine
- 2022_12_05_VLA1553_12-month_Persistence_Data_PR_EN_Final
Valneva (EU:VLA)
Graphique Historique de l'Action
De Mar 2024 à Avr 2024
Valneva (EU:VLA)
Graphique Historique de l'Action
De Avr 2023 à Avr 2024