Saint-Herblain (France), January 7, 2020 –
Valneva SE (“Valneva” or “the Company”) announced today that an End
Of Phase 2 (EOP2) meeting has been scheduled with the U.S. Food and
Drug Administration (FDA) on February 24, 2020 for its single-shot
chikungunya vaccine candidate, VLA1553. The Company plans to
present its plan for Phase 3 clinical studies and licensure.
VLA1553 has been awarded Fast Track designation by the FDA and may
be eligible for a Priority Review Voucher1.
Wolfgang Bender, M.D., Ph.D., chief
medical officer of Valneva, commented, “We are extremely
pleased that the FDA has accepted our proposal for an EOP2 meeting.
Subject to the outcome we may commence Phase 3 clinical trials
within a few months. We are strongly committed to advancing
VLA1553, currently the only chikungunya vaccine candidate in
clinical development showing fully sustained titers one year after
a single vaccination, through the accelerated approval.”
In November 2019, Valneva reported final Phase 1
results confirming VLA1553’s excellent immunogenicity and safety
profile2.The Company has also completed all required non-clinical
studies requested by the FDA.
About the Phase 1 Clinical Study
VLA1553-101This study was a randomized, observer-blinded,
multicenter, dose-escalation Phase 1 clinical study investigating
three dose levels of VLA1553, administered as a single
immunization. It enrolled 120 healthy volunteers, 18 to 45 years of
age, in the United States. Subjects were randomized into three
different study groups to receive one of three dose levels (30
subjects in the low and medium and 60 subjects in the high dose
group). The protocol includes a re-vaccination with the
live-attenuated vaccine candidate VLA1553 at Month 6 (for 30
subjects in the high dose group) or Month 12 (for all others) to
confirm that a single vaccination will be sufficient to induce high
titer neutralizing antibodies and protect subjects from
vaccine-induced viremia (intrinsic viral challenge). Study
participants were followed until 13 months after initial
vaccination. An independent Drug Safety Monitoring Board (DSMB)
continuously oversaw the study and reviewed safety data. Additional
information, including a detailed description of the study design,
eligibility criteria and investigator sites, is available at
ClinicalTrials.gov (NCT03382964).
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)3 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
Americas4 and the economic impact is considered to be
significant (e.g. Colombia outbreak 2014: $73.6m5). 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 and was granted Fast Track
designation by the U.S. Food and Drug Administration (FDA) in
December 20186.
The vaccine candidate is designed for
prophylactic, active, single-dose immunization against chikungunya
in humans over one year old. The vaccine targets long-lasting
protection and an anticipated safety profile similar to licensed
vaccines for active immunization in adults and children. 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 at up to €500 million
annually7.
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 strains8.
In pre-clinical development, a single-vaccine
shot was shown to be highly immunogenic in vaccinated Non-Human
Primates (NHP) (cynomolgus macaques) and showed no signs of viremia
after challenge9. In NHPs, VLA1553 induced a strong, long lasting
(more than 300 days) neutralizing antibody response comparable to
wild-type CHIKV infections, combined with a good safety
profile.
About Valneva SEValneva is a
biotech company developing and commercializing vaccines for
infectious 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 a unique vaccine against Lyme
disease. Valneva has operations in Austria, Sweden, the United
Kingdom, France, Canada and the US with approximately 490
employees. More information is available at www.valneva.com.
Valneva
Investor and Media ContactsLaetitia
Bachelot-FontaineGlobal Head of Investor Relations & Corporate
CommunicationsM +33 (0)6 4516 7099investors@valneva.com |
Teresa
PinzolitsCorporate Communications SpecialistT +43 (0)1 20620
1116communications@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 and completion of
research, development and clinical trials for product candidates,
the ability to manufacture, market, commercialize and achieve
market acceptance for product candidates, the ability to protect
intellectual property and operate the business without infringing
on the intellectual property rights of others, estimates for future
performance and estimates regarding anticipated operating losses,
future revenues, capital requirements and needs for additional
financing. 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 indicative of their 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. 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 A Priority Review Voucher (PRV) may be granted to the first
chikungunya vaccine approved in the US. Several chikungunya
vaccines are being developed by vaccine companies in the world.2
Valneva Reports Excellent Final Phase 1 Results for its Chikungunya
Vaccine Candidate, Confirms Plans3 WHO, PAHO4 PAHO/WHO data: Number
of reported cases of Chikungunya Fever in the Americas – EW 51
(December 22, 2017)5 Cardona-Ospina et al. 2015, Trans R Soc Trip
Med Hyg 109:793-802.6 Valneva PR: Valneva Awarded FDA Fast
Track Designation for Chikungunya vaccine candidate7 Company
estimate supported by an independent market study8 Hallengärd et
al. 2013, J. Virology 88:2858-2866.9 Roques et al. 2017, JCI
Insight 2 (6): e83527.
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