Saint-Herblain (France), January 10,
2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA)
today announced that the first participant has been vaccinated in
the Phase 2 clinical trial evaluating the safety and Immunogenicity
in children of two different dose levels of Valneva’s single-shot
chikungunya vaccine. The Company reported positive pivotal Phase 3
data in adolescents two months ago confirming the immunogenicity
and safety profile observed in adults1.There is currently no
approved chikungunya vaccine for children and Valneva’s vaccine
IXCHIQ® is currently the only licensed chikungunya vaccine2 to
address this unmet medical need in adults aged 18 years and older
who are at increased risk of exposure to the virus. Once available,
the Phase 2 pediatric data are intended to support a Phase 3
pivotal study in children with the objective to extend the label in
this age group following initial regulatory approvals in adults and
possibly in adolescents.
The multicenter, prospective, randomized,
observer-blinded, Phase 2 clinical trial is planned to enroll
approximately 300 healthy children one to eleven years of age at
three trial sites in the Dominican Republic and Honduras. Following
a safety run-in phase, participants will be randomized to receive
either a full dose formulation of the vaccine (120 participants), a
half dose formulation (120 participants) or a control vaccine (60
participants).
Juan Carlos Jaramillo M.D., Chief
Medical Officer of Valneva, said, “This pediatric trial is
extremely important. Given the significant threat that chikungunya
poses to individuals living in or traveling to endemic areas, it is
crucial to make the vaccine accessible to all age groups. By doing
so, we can broaden the protection against and reduce the impact of
this debilitating disease.”
Valneva was granted approval from the U.S. Food
and Drug Administration (FDA) for its chikungunya vaccine IXCHIQ®
in November 20233. Three marketing applications are currently under
review by the European Medicines Agency, Health Canada and the
Brazilian Health Regulatory Agency (Anvisa) with potential
approvals in 2024.
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 up to 97% of humans after
four to seven days following the mosquito bite4. While mortality
with CHIKV is low, morbidity is high, and the global market for
vaccines against chikungunya is estimated to exceed $500 million
annually by 20325. 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 110 countries6. Between 2013 and
2023, more than 3.7 million cases were reported 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. Before
IXCHIQ®, there were no preventive vaccines or
effective treatments available and, as such, chikungunya is
considered to be a major public health threat.
To make the vaccine 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 VLA15538. The collaboration falls
within the framework of the agreement signed between CEPI and
Valneva in July 20199, which provides funding of up to $23.4
million with support from the European Union’s Horizon 2020
program.
About
IXCHIQ®In the U.S.,
IXCHIQ® is a live-attenuated vaccine indicated for
the prevention of disease caused by chikungunya virus (CHIKV) in
individuals 18 years of age and older who are at increased risk of
exposure to CHIKV. As for all products approved under FDA’s
accelerated approval pathway, continued approval for this
indication is contingent upon verification and description of
clinical benefit in confirmatory studies. Please
click here for full Prescribing
Information for
IXCHIQ®.
About Phase 2 Trial VLA1553-221
VLA1553-221 is a multi-center, randomized, observer-blinded, dose
response Phase 2 clinical trial in approximately 300 healthy
children aged one to eleven years. The trial will be performed at
three trial sites in the Dominican Republic and potentially
Honduras. The primary and secondary objectives of the trial are to
evaluate the safety and immunogenicity of two different dose levels
of Valneva’s single-shot chikungunya vaccine. Additional
information, including a detailed description of the trial design,
eligibility criteria and investigator sites, is available at
ClinicalTrials.gov (Identifier: NCT06106581).
About Valneva SEWe are a
specialty vaccine company that develops, manufactures, and
commercializes prophylactic vaccines for infectious diseases
addressing unmet medical needs. We take a highly specialized and
targeted approach, applying our deep expertise across multiple
vaccine modalities, focused on providing either first-, best- or
only-in-class vaccine solutions.
We have a strong track record, having advanced
multiple vaccines from early R&D to approvals, and currently
market two proprietary travel vaccines as well as certain
third-party vaccines leveraging our established commercial
infrastructure.
Revenues from our growing commercial business
help fuel the continued advancement of our vaccine pipeline. This
includes the world’s first vaccine against the chikungunya virus
and the only Lyme disease vaccine candidate in advanced clinical
development, which is partnered with Pfizer, as well as vaccine
candidates against the Zika virus and other global public health
threats.
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
and delays 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 Reports Positive Pivotal Phase 3 Immunogenicity Data
in Adolescents for its Single-Shot Chikungunya Vaccine Candidate -
Valneva2 Valneva Announces U.S. FDA Approval of World’s First
Chikungunya Vaccine, IXCHIQ® - Valneva3 Valneva Announces U.S.
FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® -
Valneva4 Staples, J.E. Hills, S.L. Powers, A.M. "Chikungunya." In
CDC Yellow Book 2020: Health Information for International Travel,
by Centers for Disease Control and Prevention. New York: Oxford
University Press, 20205 VacZine Analytics Chikungunya virus
vaccines Global demand analysis. February 20206
https://www.who.int/news-room/fact-sheets/detail/chikungunya7
PAHO/WHO data: Number of reported cases of chikungunya fever in the
Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017).
https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html.
Last accessed 01 Aug 2023.8 Valneva and Instituto Butantan Sign
Final Agreement on Single-Shot Chikungunya Vaccine for Low and
Middle Income Countries9 CEPI awards up to $23.4 million to Valneva
for late-stage development of a single-dose Chikungunya vaccine
- 2024_01_10_VLA1553-221_Inititiation_PR_EN_Final
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