First Chikungunya Vaccine Candidate to Enter
Phase 3 Clinical Development
Saint-Herblain (France), September 8,
2020 – Valneva SE (“Valneva” or “the Company”) a specialty
vaccine company focused on prevention of diseases with major unmet
needs, today announced the initiation of a pivotal Phase 3 clinical
trial for its differentiated, single-shot chikungunya vaccine
candidate VLA1553. The sponsor of the first chikungunya
vaccine Biologics License Application (BLA) to be approved in the
U.S. will be eligible to receive a Priority Review Voucher (PRV)
1.
The study, called VLA1553-301, is a
double-blinded, placebo-controlled, multi-center study in
approximately 4,000 healthy adults aged 18 or above, conducted in
the U.S. Participants will be randomized into two study groups to
receive either vaccine or placebo. The primary endpoint will be to
demonstrate safety and immunogenicity 28 days after a single-shot
vaccination with VLA1553. A subset of participants will be tested
for sero-protection based on an immunological surrogate (under the
Accelerated Approval pathway). Participants will be followed for a
total of six months.
The total duration of the study is expected to
be nine months and the outcome, if positive, shall provide the
basis for licensure of the vaccine.
Wolfgang Bender, M.D., Ph.D., Chief
Medical Officer of Valneva, commented, “We are the first
company worldwide to advance a chikungunya vaccine candidate into
Phase 3. We believe that VLA1553 has best-in class potential.
Developing a vaccine against chikungunya is critical as the virus
represents a major public health threat and there are currently no
preventive vaccines or effective treatments available. We would
like to thank our employees who are making this trial possible
despite the ongoing COVID-19 pandemic.”
Valneva plans to take VLA1553 to market with the
prospect of leveraging major manufacturing and commercial synergies
with its existing travel vaccines portfolio.
The target population segments are travelers,
military personnel and individuals at risk living in endemic
regions. The global market for vaccines against chikungunya is
estimated to exceed $500 million annually, including a traveler
vaccine market potential of ~$250 million.
To make VLA1553 also accessible to Low and
Middle Income Countries (LMIC), Valneva and Instituto Butantan in
Brazil signed a binding term sheet in May 2020 for the development,
manufacturing and marketing of VLA1553. The collaboration will be
effective upon the signing of definitive agreements and will fall
within the framework of the $23.4 million funding which Valneva
received from the Coalition for Epidemic Preparedness Innovations
(CEPI) in July 2019.
About Chikungunya Chikungunya
is a mosquito-borne viral disease caused by the chikungunya virus
(CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
Clinical symptoms include acute onset of fever, debilitating joint
and muscle pain, headache, nausea and rash, potentially developing
into long-term, serious health impairments. Chikungunya virus
causes clinical illness in 72-92% of infected humans around 4 to 7
days after an infected mosquito bite. Complications resulting from
the disease include visual, neurological, heart and
gastrointestinal manifestations; fatalities have been reported
(case fatality rates of 0.1% to 4.9% from epidemics)2 in elderly
patients at higher risk. Chikungunya outbreaks have been reported
in Asia, Africa, the Americas and recently (2017) in Europe. As of
2017, there have been more than one million reported cases in the
Americas3 and the economic impact is considered to be
significant (e.g. Colombia outbreak 2014: $73.6 million4). The
medical and economic burden is expected to grow as the CHIKV
primary mosquito vectors continue to further spread geographically.
There are no preventive vaccines or effective treatments available
and, as such, chikungunya is considered to be a major public health
threat.
About VLA1553VLA1553 is a
monovalent, single dose, live-attenuated vaccine candidate for
protection against chikungunya. VLA1553 is based on an infectious
clone (CHIKV LR2006-OPY1) attenuated by deleting a major part of
the gene encoding the non-structural replicase complex protein
nsP3, aiming for protection against various chikungunya virus
outbreak phylogroups and strains5. The vaccine candidate is
designed for prophylactic, active, single-dose immunization against
chikungunya. As a live-attenuated vaccine, VLA1553 is particularly
well suited to target long-lasting protection. The safety
profile is anticipated to be similar to licensed vaccines for
active immunization in adults and children. The program was granted
Fast Track designation by the U.S. Food and Drug Administration
(FDA) in December 20186. During the first half of 2020, VLA1553’s
complete Phase 1 data were published in the peer-reviewed medical
journal The Lancet Infectious Diseases. The Lancet paper provides a
detailed analysis of the unique Phase 1 results (Phase 1:
VLA1553-101, ClinicalTrials.gov identifier NCT03382964), which
served as a basis for the Company´s End of Phase 2 meeting with the
U.S. FDA and supported the direct progression into Phase 3.
About the study VLA1553-301
This study is a prospective, double-blinded, multicenter,
randomized, pivotal Phase 3 study comprising approximately 4,000
participants aged 18 years or above randomized in a 3:1 ratio to
the live-attenuated CHIKV vaccine candidate (VLA1553) or placebo.
The study will be conducted at multiple sites across the U.S. The
final dose of lyophilized VLA1553 or placebo will be administered
as a single intramuscular immunization. The primary objective of
the study is to evaluate the immunogenicity and safety of the final
dose of VLA1553 28 days following the single immunization.
Immunogenicity evaluations in a subset of participants will include
the proportion of participants with seroprotective neutralizing
CHIKV antibody titers above a surrogate threshold indicative of
protection. The surrogate of protection reasonably likely to
predict clinical benefit has been established in non-human primate
passive transfer studies using human sera from the Phase 1 study.
Safety data collection and immunogenicity will continue to be
assessed until Month 6. Additional information, including a
detailed description of the study design, eligibility criteria and
investigator sites, will become available at ClinicalTrials.gov
About Valneva SEValneva is a
specialty vaccine company focused on prevention against diseases
with major unmet needs. Valneva’s portfolio includes two commercial
vaccines for travelers: IXIARO®/JESPECT® indicated for the
prevention of Japanese encephalitis and DUKORAL® indicated for the
prevention of cholera and, in some countries, prevention of
diarrhea caused by ETEC. The Company has various vaccines in
development including unique vaccines against Lyme disease,
chikungunya and COVID-19. Valneva has operations in Austria,
Sweden, the United Kingdom, France, Canada and the US with over 500
employees. For more information, visit the Company website at
www.valneva.com and follow Valneva on LinkedIn.
Valneva
Investor and Media ContactsLaetitia
Bachelot-FontaineDirector Investor Relations & Corporate
CommunicationsM +33 (0)6 4516
7099investors@valneva.com |
Teresa
PinzolitsCorporate Communications SpecialistT +43 (0)1 20620
1116communications@valneva.com |
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forward-looking statements relating to the business of Valneva,
including with respect to the progress, timing and completion of
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1 https://priorityreviewvoucher.org/2 WHO, PAHO3 PAHO/WHO data:
Number of reported cases of Chikungunya Fever in the Americas – EW
51 (December 22, 2017)4 Cardona-Ospina et al. 2015, Trans R Soc
Trip Med Hyg 109:793-802.5 Hallengärd et al. 2013, J.
Virology 88:2858-2866.6 Valneva PR: Valneva Awarded FDA Fast Track
Designation for Chikungunya vaccine candidate
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