Valneva Initiates Phase I Clinical Study to
Evaluate Its Single-Shot Vaccine Candidate against
Chikungunya
Lyon (France), March 13, 2018 - Valneva SE, a
fully integrated commercial stage biotech company focused on
developing innovative, lifesaving vaccines, today announced the
initiation of a Phase I clinical trial in the U.S. to evaluate the
safety and immunogenicity of VLA1553, its live-attenuated vaccine
candidate against Chikungunya.
The Phase I clinical trial is a randomized,
observer-blinded, dose-escalation, multi-center study. It will
investigate three different dose levels of VLA1553 in approximately
120 healthy adults vaccinated with a single-shot immunization.
The trial design includes the investigation of
antibody persistence and an additional vaccination using the
highest dose of VLA1553 at 6 and 12 months. This re-vaccination
will serve as an intrinsic human viral challenge, aiming to
demonstrate that subjects are protected from vaccine-induced
viremia thereby indicating potential efficacy of VLA1553 early in
clinical development.
First data from the trial are expected to be
available early 2019.
Wolfgang Bender, MD, PhD, Chief Medical
Officer of Valneva commented "We are proud to contribute to the
ongoing global efforts to develop effective prevention against the
increasing threat to public health caused by the Chikungunya virus.
We have developed a sophisticated Phase I design with the intent to
provide us with an early indication of competitive advantage that
we anticipate for our vaccine candidate."
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[1]. 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)1 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 Americas[2] and the
economic impact is considered to be significant (e.g. Columbia
outbreak 2014: $73.6m[3]). 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 VLA1553
VLA1553 is a monovalent, single dose,
live-attenuated vaccine candidate for protection against
Chikungunya. It is designed for prophylactic, active, single-dose
immunization against Chikungunya in humans over one year old. The
vaccine aims for long-lasting protection and an anticipated safety
profile similar to licensed vaccines for active immunization in
adults and children. The target population segments are travellers,
military personnel and individuals at risk living in endemic
regions. The global market for vaccines against Chikungunya is
estimated at up to €500 million annually[4].
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 strains[5].
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 challenge[6]. 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 SE
Valneva is a fully integrated, commercial stage
biotech company focused on developing innovative life-saving
vaccines.
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 proprietary 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 over 450 employees.
More information is available at www.valneva.com.
Valneva Investor and Media Contacts Laetitia
Bachelot-Fontaine Global Head of Investor Relations & Corporate
Communications T +33 (0)2 2807 1419 M +33 (0)6 4516 7099
investors@valneva.com |
Teresa Pinzolits Corporate Communications Specialist T
+43 1206 201 116 Communications@valneva.com |
Valneva 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 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 in this press
release will in fact be realized. Valneva is providing the
information in these materials as of the date of this press
release, and disclaims 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] WHO, PAHO
[2] PAHA/WHO data: Number of reported cases of Chikungunya Fever
in the Americas - EW 51 (December 22, 2017)
[3] Cardona-Ospina et al., Trans R Soc Trip Med Hyg 2015
[4] Company estimate support by an independent market study
[5] Hallengärd et al. 2013 J. Virology 88: 2858-2866
[6] Roques et al. 2017JCI Insight 2 (6): e83527
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