Valneva Reports Positive
24-Month Antibody Persistence Data for its Single-Shot Chikungunya
Vaccine IXCHIQ®
- Primary endpoint met with 97%
seroresponse rate 24 months after a single vaccination
- Antibody levels remained high and
well above the seroresponse threshold, further supporting the
anticipated long-term durability of the immune response
-
No safety concerns identified in long-term follow up
Saint-Herblain (France), December 4,
2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company, today reported positive antibody
persistence data twenty-four months after vaccination with a single
dose of its chikungunya vaccine IXCHIQ®, further supporting the
anticipated long-term durability of the immune response and in line
with positive twelve-month persistence data the Company reported in
December 20221. These persistence data are intended to supplement
the existing approval by U.S. FDA and ongoing regulatory approval
processes.
97% of the 316 healthy adults still enrolled in
the trial retained neutralizing antibody titers above the
seroresponse threshold2 twenty-four months after the single-dose
vaccination. The persistence of antibodies in older adults aged 65
and above was as robust as in younger adults, and even slightly
higher in terms of geometric mean titers (GMTs) and seroconversion
rates (SRRs). This outcome underscores the vaccine's potential to
offer strong and lasting protection against chikungunya across
different age groups. These results follow completion of the
pivotal Phase 3 study published in the Lancet3 in which a
seroresponse rate of 96% six months after a single vaccination1 was
reported.
Study VLA1553-303 collected long-term safety by
following any Adverse Event of Special Interest (AESI) from the
preceding study and collecting new-onset SAEs. No safety concerns
were identified for the duration of the 24-month follow-up and, as
reported in the 12-months data analysis, no AESI was ongoing when
participants were enrolled in the trial.
Juan Carlos Jaramillo M.D., Chief
Medical Officer of Valneva, said, “We are very pleased
about these twenty-four-month data which confirm IXCHIQ®'s ability
to induce a robust, long-lasting antibody response in both younger
and older adults with a single vaccination. Being the world's first
approved vaccine against chikungunya, each positive outcome further
strengthens the defense against this significant and expanding
public health threat.”
Valneva was granted U.S. FDA approval4 for its
chikungunya vaccine IXCHIQ® in November 20235. Two marketing
applications are currently under review by EMA and Health Canada
with potential approvals in mid-2024. A clinical study in
adolescents is also ongoing in Brazil for which the Company
reported positive pivotal Phase 3 data in November 20236. This
study is intended to support label extension in this age group and
licensure of the vaccine in Brazil, which would be the first
potential approval for use in endemic populations.
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 bite7. 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 20328. 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 countries9. Between 2013 and
2023, more than 3.7 million cases were reported in the Americas10
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.
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.
IXCHIQ®
(chikungunya virus, live) Solution for Intramuscular
Injection
IndicationIXCHIQ® is a vaccine
indicated for the prevention of disease caused by chikungunya virus
(CHIKV) in individuals 18 years and older who are at increased risk
of exposure to CHIKV. This indication is approved under accelerated
approval based on anti-CHIKV neutralizing antibody titers.
Continued approval for this vaccine is contingent upon verification
and description of clinical benefit in confirmatory studies.
IMPORTANT SAFETY INFORMATION ABOUT
IXCHIQ® – Please consult the full
prescribing information for all the labeled safety information.
ContraindicationsIXCHIQ® should
not be given to individuals who have a weakened immune system due
to medications used for hematologic and solid tumors, on
chemotherapy, history of congenital immunodeficiency, long-term
immunosuppressive therapy, or patients with HIV infection who are
severely immunocompromised.
Individuals with a history of a severe allergic
reaction to any component of the vaccine.
WarningsAppropriate
medical treatment used to manage immediate allergic
reactions must be available in the event an acute
anaphylactic reaction following administration of
IXCHIQ® or any vaccine.
Vaccination with
IXCHIQ® may cause severe or
prolonged chikungunya-like adverse reactions. Severe
chikungunya-like adverse reactions that prevented daily activity
and/or required medical intervention occurred in 1.6% of 3,082
IXCHIQ® recipients and no placebo recipients.
Fourteen IXCHIQ® recipients had prolonged
(duration at least 30 days) chikungunya-like adverse reactions.
Infection of pregnant individuals with
wild-type chikungunya virus can result in
intra-partum transmission and potentially fatal neonatal
complications. IXCHIQ® should be
administered during pregnancy only after an individual risk-benefit
assessment, considering maternal risk of chikungunya infection and
gestational age.
Fainting can occur with administration of
IXCHIQ®. Procedures should be in place to avoid
injury from fainting.
IXCHIQ®
may not protect all individuals who receive the
vaccine.
Adverse ReactionsThe most
common injection site reaction (>10%) was tenderness (11%) and
the most common systemic adverse reactions (>10%) were headache
(31%), fatigue (29%), myalgia (24%), arthralgia (17%), fever (13%)
and nausea (11%).
Use in Specific Populations
Pregnancy
There are no adequate and well-controlled
studies of IXCHIQ® in pregnant individuals, and
human data available from clinical trials with
IXCHIQ® are insufficient to establish the presence
or absence of vaccine-associated risk during pregnancy.
Please click here for
full Prescribing Information for
IXCHIQ®.
About Phase 3 trial VLA1553-303
VLA1553-303 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 one to five 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 clinical study and collecting new-onset SAE up
to two years. 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 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 12-Month Antibody Persistence Data
for 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 Announces Publication of its
Chikungunya Vaccine Candidate Phase 3 Data in The
Lancet4 Valneva Announces U.S. FDA Approval of World’s First
Chikungunya Vaccine, IXCHIQ® - Valneva5 Valneva Announces U.S.
FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® -
Valneva6 Valneva Reports Positive Pivotal Phase 3 Immunogenicity
Data in Adolescents for its Single-Shot Chikungunya Vaccine
Candidate - Valneva7 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, 20208 VacZine
Analytics Chikungunya virus vaccines Global demand analysis.
February 20209
https://www.who.int/news-room/fact-sheets/detail/chikungunya10
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.
- 2023_12_04_IXCHIQ_2Y_Persistence_PR_EN_Final
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