Valneva Completes Enrollment for Adolescent Phase 3 Trial of
Single-Shot Chikungunya Vaccine Candidate
Saint-Herblain
(France),
February 14,
2023 – Valneva
SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine
company, today announced that it completed enrollment and
vaccination for a Phase 3 trial in adolescents, VLA1553-321, of its
single-shot chikungunya vaccine candidate, VLA1553. First results
of the trial are expected mid-2023.
Funded by the Coalition for Epidemic Preparedness
Innovations (CEPI), the VLA1553-321 adolescent trial is intended to
support the label extension in this age group following a potential
initial regulatory approval in adults from the Food and Drugs
Administration (FDA) in the United States (U.S).Valneva completed
rolling submission of the Biologics License Application (BLA) to
the U.S. FDA for approval of VLA1553 in persons aged 18 years and
above in December 20221. If BLA filing is accepted and approved,
VLA1553 could become the first chikungunya vaccine to be marketed
in the U.S. Valneva reported final pivotal Phase 3 data for VLA1553
in March 20222 and final lot-to-lot consistency results in May
20223. The Company also recently reported positive antibody
persistence data with a 99% seroresponse rate 12 months after a
single-dose vaccination4.
The VLA1553-321 adolescent trial is also
expected to support licensure of the vaccine in Europe and Brazil,
which would be the first potential approval for use in endemic
populations.
Conducted in collaboration between Instituto
Butantan and Valneva, VLA1553-321 is a double-blinded,
multi-center, randomized and placebo-controlled Phase 3 trial. 754
adolescents aged 12 to 17 years were vaccinated following
randomization at a 2:1 ratio to receive either VLA1553 or placebo.
The primary objective of the trial is to evaluate safety and
immunogenicity 28 days following a single vaccination with VLA1553.
Participants will be evaluated for the primary endpoint and
followed up to twelve months. The study will also provide the first
systematic safety and immunogenicity data in participants
previously exposed to chikungunya.
Juan Carlos Jaramillo,
M.D., Chief Medical Officer of Valneva, commented,
“Recruitment completion in this study is an important milestone for
the overall program. We reported compelling pivotal Phase 3 results
in adults and in the elderly, and we are now looking forward to
obtaining results in adolescents later this year. Chikungunya virus
is a major, growing public health threat which has already impacted
over 100 countries and affected millions worldwide, yet no vaccine
or specific treatment is currently available to prevent this
debilitating disease.”
Dr. Esper Georges
Kallas, President of
Instituto Butantan,
which will
develop, manufacture and
market VLA1553 in Low- and
Middle-Income
Countries, commented,
“the achievement of this goal is a major milestone to expand the
vaccine indication in adolescents. Based on a single-dose schedule,
the VLA1553 chikungunya vaccine could become a key tool to prevent
the chikungunya disease in endemics areas and fight the
disease-induced public health
burden.”Dr. Melanie
Saville, Director of Vaccine Research
& Development at
CEPI,
which provided funding
for this study, added,
“Millions of people have been affected by
chikungunya and, today, over a billion people live in areas where
chikungunya outbreaks occur. The progress Valneva has made to date
brings the world one step closer towards a safe and effective
vaccine against this debilitating disease, for which there is
currently no specific treatment nor vaccine licenced for human use.
Data from this Phase 3 study will help to ensure that the people
most affected by this virus can benefit from this product and help
regulators assess this important vaccine candidate.”
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 VLA15535. The collaboration falls
within the framework of the agreement signed between CEPI and
Valneva in July 20196, which provides funding of up to $24.6
million with support from the European Union’s Horizon 2020
program.
Brazil had an exponential increase of
chikungunya cases in 2021 in comparison to 2020, according to data
from the Brazilian Vigilance Health Secretary (SVS). At the
beginning of December 2021, 90,147 chikungunya cases had been
registered compared to 78,808 over the same period in the previous
year. The three states that most registered cases of the disease
were Pernambuco (29,700 cases), São Paulo (18,100 cases) and
Paraíba (9,000 cases), respectively. In 2021, São Paulo which is
the most populous state in the country, went from 468 cases to
18,156 cases compared to 20207.
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 Americas7 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 transmission8. 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 investigational 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.Valneva reported final data from the pivotal Phase 3 trial
of VLA1553 in March 20229 and final lot-to-lot consistency results
in May 202210.If approved, VLA1553 would expand Valneva’s existing
commercial vaccines portfolio and as such, Valneva intends to
commercialize this vaccine, leveraging its existing manufacturing
and commercial operations. 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 VLA155311. The collaboration falls
within the framework of the agreement signed between CEPI and
Valneva in July 201912, which provides funding of up to $24.6
million with support from the European Union’s Horizon 2020
program.
About Phase 3 study
VLA1553-321VLA1553-321 is a prospective, double-blinded,
multicenter, randomized, placebo-controlled pivotal Phase 3 trial
conducted in 754 adolescents aged 12 to 17 years old in Brazil.
VLA1553 or placebo will be administered as a single intramuscular
immunization to participants who will be randomized into two study
groups at a 2:1 ratio. The primary objective is to evaluate the
immunogenicity and safety of the adult dose of VLA1553 28 days
following a single vaccination. Secondary objectives of the trial
will include assessment of safety and immunogenicity up to twelve
months following a single vaccination with VLA1553. The study will
also provide safety and immunogenicity data in participants
previously exposed to chikungunya.Additional information, including
a detailed description of the study design, eligibility criteria
and investigator sites, is available at ClinicalTrials.gov
(Identifier: NCT04650399).
About Valneva SEValneva is a
specialty vaccine company focused on the development, manufacturing
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.
About Instituto
ButantanInstituto Butantan is the main producer of
immunobiological products and vaccines in Brazil. Instituto
Butantan carries out scientific missions domestically and abroad
through the Pan American Health Organization, the World Health
Organization, UNICEF and the United Nations. The Institute
collaborates with other agencies of the São Paulo State Secretariat
of Health and the Brazilian Ministry of Health for the improvement
of overall health in Brazil. It acts in partnership with various
universities and entities such as the Bill & Melinda Gates
Foundation for the achievement of its institutional objectives. For
more information please visit the Institute website at
www.butantan.gov.br or contact the press office at (+55 11)
2627-9606 / 9428 or email to imprensa@butantan.gov.br
About CEPICEPI is an innovative
partnership between public, private, philanthropic, and civil
organizations, launched at Davos in 2017, to develop vaccines to
stop future epidemics. Before the emergence of COVID-19 CEPI’s
priority diseases included Ebola virus, Lassa virus, Middle East
Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever
and chikungunya virus. CEPI also invested in platform technologies
that can be used for rapid vaccine and immunoprophylactic
development against unknown pathogens (Disease X). CEPI has moved
with great urgency and in coordination with WHO in response to the
emergence of COVID-19. CEPI has initiated 9 partnerships to develop
vaccines against the novel coronavirus. The programmes will
leverage rapid response platforms already supported by CEPI as well
as new partnerships. The aim is to advance COVID-19 vaccine
candidates into clinical testing as quickly as possible.CEPI,
alongside Gavi and the World Health Organisation, co-leads the
vaccines pillar of the ACT Accelerator – known as COVAX – which is
working to develop, distribute and deploy COVID-19 vaccines to the
world. Learn more at http://www.cepi.net.
Follow CEPI at @CEPIvaccines.
Valneva
Investor and Media ContactsLaetitia Bachelot-FontaineVP
Global Communications & European Investor RelationsM +33 (0)6
4516
7099laetitia.bachelot-fontaine@valneva.com |
Joshua
Drumm, Ph.D.VP Global Investor RelationsM +001 917 815
4520joshua.drumm@valneva.com |
Forward-Looking Statements
This 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, to regulatory approval of product candidates and review
of existing products. 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 Completes BLA Submission to U.S. FDA for its
Single-Shot Chikungunya Vaccine Candidate - Valneva2 Valneva
Successfully Completes Pivotal Phase 3 Trial of Single-Shot
Chikungunya Vaccine Candidate3 Valneva Successfully Completes
Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya
Vaccine Candidate4 Valneva Reports Positive 12-Month Antibody
Persistence Data for Single-Shot Chikungunya Vaccine Candidate -
Valneva5 Valneva and Instituto Butantan Sign Final Agreement on
Single-Shot Chikungunya Vaccine for Low and Middle Income
Countries6 CEPI awards up to $23.4 million to Valneva for
late-stage development of a single-dose Chikungunya vaccine7
https://www.gov.br/saude/pt-br/assuntos/noticias/2021-1/novembro/sao-paulo-e-o-estado-com-o-maior-aumento-do-numero-de-casos-de
chikungunya.7 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 2020.8 CDC 2022, Puntasecca CJ 20219 Valneva
Successfully Completes Pivotal Phase 3 Trial of Single-Shot
Chikungunya Vaccine Candidate10 Valneva Successfully Completes
Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya
Vaccine Candidate11 Valneva and Instituto Butantan Sign Final
Agreement on Single-Shot Chikungunya Vaccine for Low and Middle
Income Countries12 CEPI awards up to $23.4 million to Valneva for
late-stage development of a single-dose Chikungunya vaccine
- 2023_02_14_VLA1553-321_Enrollment_Completion_PR_EN_Final
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