Valneva Reports Positive
End-of-Phase 2 Chikungunya Meeting with the U.S. FDA; Sets Stage
for Phase 3 Study
- Development plan towards licensure endorsed with FDA
- Approval through Accelerated Approval Pathway1 (immunological
surrogate)
- Main Phase 3 trial planned as double-blind, placebo-controlled,
multi-center study
- Dose Selection for Phase 3, manufacturing and industrialization
strategy accepted
- Study initiation as soon as COVID-19 situation permits
- Currently anticipated for the fourth quarter 2020
- Primary endpoint analysis is expected six months
thereafter
- Seamless fit with Valneva’s existing commercial and
manufacturing capabilities as a plug and play asset
Saint-Herblain (France), March 25,
2020 – Valneva SE (“Valneva” or “the Company”) announced
today that it has successfully completed an End-of-Phase 2 meeting
with the U.S. Food and Drug Administration (FDA) and agreed on the
clinical development plan towards licensure for its unique,
single-shot chikungunya vaccine, VLA1553.
Regulatory approval will be based on an
immunological surrogate (Accelerated Approval Pathway).
The main Phase 3 pivotal trial will be, subject
to detailed protocol review, a double-blinded, placebo-controlled,
multi-center study in approximately 4,000 healthy adults. Subjects
will be randomized into two study groups to receive either vaccine
or placebo; a subset will be tested for seroprotection. The primary
endpoint of the study will be to demonstrate safety and
immunogenicity after a single-shot vaccination with VLA1553 at Day
29 (one month after immunization). The final analysis will be
conducted at Day 180 (six months after immunization). The total
duration of the study is expected to be nine months.
As previously announced, the chikungunya vaccine
represents a seamless fit with Valneva’s existing commercial and
manufacturing capabilities as a plug-and play asset.
Wolfgang Bender, M.D., Ph.D., Chief
Medical Officer of Valneva, commented, “We would like to
thank the U.S. FDA for a productive End of Phase 2 meeting. We look
forward to further demonstrating the best-in class potential of our
single-shot chikungunya vaccine VLA1553 in our Phase 3 program.
Providing a vaccine against chikungunya is critical as the virus is
considered a major public health threat and there are currently no
preventive vaccines or effective treatments available. We are
thrilled about the prospect to potentially have a vaccine available
by the end of 2022.”
The Company is preparing for Phase 3 initiation
as soon as the COVID-19 situation permits. Currently, the company
assumes that Phase 3 can be initiated in the fourth quarter of this
year.
Valneva’s chikungunya vaccine candidate was
granted Fast Track designation by the FDA in December 2018 and
received confirmation for the Accelerated Approval Pathway at the
end of February 2020 during the EOP2 meeting with the FDA2.
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)3.
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 included 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 would 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. The
vaccine candidate showed an excellent immunogenicity profile in all
vaccinated dose groups after a single vaccination, with a 100%
seroconversion4 achieved at Day 14. Titers were sustained at 100%
at Month 12. VLA1553 was generally safe and well-tolerated with a
superior safety profile in low and medium dose groups compared to
the high dose group, and showed an excellent local
tolerability.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)5 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
Americas6 and the economic impact is considered to be
significant (e.g. Colombia outbreak 2014: $73.6 million7). 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 20188. 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 to exceed $500 million annually9, including a traveler
vaccine market potential of ~$250 million. 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 strains10.
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 and
chikungunya. Valneva has operations in Austria, Sweden, the United
Kingdom, France, Canada and the US with over 500 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
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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
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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
https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
2 Valneva press release: Valneva Awarded FDA
Fast Track Designation for Chikungunya Vaccine Candidate3
https://priorityreviewvoucher.org/4 Seroconversion is defined as
the proportion of subjects achieving a CHIKV-specific neutralizing
antibody titer of NT50 ≥20.5 WHO, PAHO6 PAHO/WHO data: Number of
reported cases of Chikungunya Fever in the Americas – EW 51
(December 22, 2017)7 Cardona-Ospina et al. 2015, Trans R Soc Trip
Med Hyg 109:793-802.8 Valneva PR: Valneva Awarded FDA Fast
Track Designation for Chikungunya vaccine candidate9 Company
estimate supported by an independent market study10 Hallengärd et
al. 2013, J. Virology 88:2858-2866.
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