Valneva Reports Further Positive Pivotal Phase 3 Data in
Adolescents for its Single-Shot Chikungunya Vaccine
Results Intended to Support Filing for
Potential Label Extension for Use in Adolescents
Saint-Herblain (France), May 13,
2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company, today reported further positive pivotal
Phase 3 data in adolescents for its single-shot chikungunya virus
(CHIKV) vaccine. Following the initial analysis up to Day 29
post-vaccination, the most recent analysis of study VLA1553-321
evaluated the safety and immunogenicity six months (Day 180) after
vaccination with a single dose of the vaccine. The Day 180 results
confirm the initial positive immunogenicity and safety data Valneva
reported previously1,2, and are intended to support filing for
potential label extension for use in adolescents aged 12 to 17
years. The data are also expected to support licensure of IXCHIQ®
in Brazil, which would be the first potential approval for use in
endemic populations.
The latest VLA1553-321 data confirmed that a
single-dose vaccination with VLA1553 induced a high, sustained
immune response with a seroresponse rate of 99.1% (232 out of 234
participants) at Day 180 compared to 98.8% (248 out of 251
participants) at Day 29 in an immunogenicity subset of individuals
who were CHIKV negative at baseline.
Geometric mean antibody titers (GMTs)
consistently surpassed the seroresponse threshold defined with the
U.S. Food and Drug Administration (FDA)3 as the surrogate of
protection in baseline seronegative participants who received a
single dose of VLA1553.
Additionally, the Day 180 data confirmed that a
single dose of the vaccine was generally safe and well tolerated in
adolescents receiving VLA1553, irrespective of previous infection
with the chikungunya virus. Throughout the trial, an Independent
Data Safety Monitoring Board (IDSMB) consistently assessed safety
data and found no safety issues. The majority of solicited adverse
events observed following VLA1553 administration were mild or
moderate and resolved within three days post vaccination.
Juan Carlos Jaramillo M.D., Chief
Medical Officer of Valneva, said, “We are highly
encouraged by these data, as they reinforce the strong immunity and
safety observed in adults and the elderly, upon which FDA approval
was granted. Given the substantial risk that chikungunya presents
to individuals residing in or traveling to endemic regions, it's
imperative to ensure the vaccine is available to all age groups.
This broader accessibility can help provide protection and mitigate
the burden of this debilitating illness."
Conducted in collaboration with Instituto
Butantan in Brazil and funded by the Coalition for Epidemic
Preparedness Innovations (CEPI) with support from the European
Union’s Horizon 2020 program, the VLA1553-321 trial represents the
first clinical trial conducted in an endemic area and with
individuals previously infected with CHIKV.
Valneva’s vaccine IXCHIQ® is the world’s first
and only licensed chikungunya vaccine available to address this
significant unmet medical need. It was approved by the U.S. FDA in
November 20234, and the Centers for Disease Control and Prevention
(CDC) recently adopted the Advisory Committee on Immunization
Practices’ (ACIP) recommendations on use of the vaccine in the
U.S.5. 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.
IXCHIQ®’s final pivotal Phase 3 data were published in The Lancet,
the world’s leading peer-reviewed medical journal, in June
20236.
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. The
VLA1553-321 clinical trial was initiated in January 2022 and
Valneva reported initial immunogenicity and safety data in
November7 and August 20238, respectively. VLA1553 or placebo was
administered as a single intramuscular immunization to participants
who were 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 in adolescents 28 days following a single
vaccination. Secondary objectives of the trial include assessment
of safety and immunogenicity up to twelve months following a single
vaccination with VLA1553. Additional information, including a
detailed description of the study design, eligibility criteria and
investigator sites, is available at ClinicalTrials.gov (Identifier:
NCT04650399).
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 bite9. 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 203210. Clinical symptoms include acute onset of fever,
debilitating joint and muscle pain, headache, nausea, rash and
chronic arthralgia. The 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 countries11. Between 2013 and
2023, more than 3.7 million cases were reported in the Americas12
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 VLA155313. The collaboration falls
within the framework of the agreement signed between CEPI and
Valneva in July 201914, which provides funding of up to $24.6
million with support from the European Union’s Horizon 2020
program. Regulatory review by the Brazilian authority ANVISA is
ongoing.
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 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 three 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 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 Candidate2
Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents
for its Single-Shot Chikungunya Vaccine Candidate3 Defined as
µPRNT50 antibody titer ≥ 150 agreed with the FDA as surrogate of
protection to support accelerated approval4 Valneva Announces
U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® -
Valneva5 ACIP Vaccine Recommendations and Schedules | CDC6 Safety
and immunogenicity of a single-shot live-attenuated chikungunya
vaccine: a double-blind, multicentre, randomised,
placebo-controlled, phase 3 trial - The Lancet7 Valneva Reports
Positive Pivotal Phase 3 Immunogenicity Data in Adolescents for its
Single-Shot Chikungunya Vaccine Candidate8 Valneva Reports Positive
Initial Phase 3 Safety Data in Adolescents for its Single-Shot
Chikungunya Vaccine Candidate9 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, 202010 VacZine
Analytics Chikungunya virus vaccines Global demand analysis.
February 202011
https://www.who.int/news-room/fact-sheets/detail/chikungunya12
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 2023.13 Valneva and Instituto Butantan Sign
Final Agreement on Single-Shot Chikungunya Vaccine for Low and
Middle Income Countries14 CEPI awards up to $23.4 million to
Valneva for late-stage development of a single-dose Chikungunya
vaccine
- 2024_05_13_VLA1553-321_6Month_PR_EN_Final
Valneva (LSE:0OB3)
Historical Stock Chart
From Aug 2024 to Sep 2024
Valneva (LSE:0OB3)
Historical Stock Chart
From Sep 2023 to Sep 2024