Valneva Announces Publication in The Lancet of Complete Phase 1
Data for its Single-Shot Chikungunya Vaccine Candidate
Saint-Herblain (France), June 2, 2020 – Valneva
SE (“Valneva” or “the Company”), a specialty vaccine company,
announced today the publication of full data from the Phase 1
clinical trial of its chikungunya vaccine candidate, VLA1553, in
the peer-reviewed medical journal The Lancet Infectious
Diseases.
The Lancet paper provides a detailed analysis of
final Phase 1 results and supports the continued clinical
development of VLA1553.
Wolfgang Bender, Ph.D., M.D., Chief
Medical Officer of Valneva, commented, “We reported
excellent Phase 1 results1 for our single-shot chikungunya vaccine
and we’re pleased that these important results are now fully
available to the broader infectious disease community. Millions of
people have been affected by chikungunya and our objective is to
help address this ongoing public health crisis as soon as we
can."
Valneva has previously reported the successful
outcome of its End-of-Phase 2 meeting with the U.S. Food and Drug
Administration (FDA)2 in February 2020 and is now preparing to
initiate Phase 3 clinical studies in the U.S. later this year.
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., 2014 Colombia outbreak: $73.6 million5). 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 Valneva’s vaccine candidate
VLA1553VLA1553 is a monovalent, single dose,
live-attenuated vaccine candidate for protection against
chikungunya. It 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 to exceed $500 million annually, including a traveler
vaccine market potential of ~$250 million7. 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.
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 U.S. with over 500 employees. For
more information, visit www.valneva.com and follow the company on
LinkedIn.
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 Valneva Reports Excellent Final Phase 1 Results for its
Chikungunya Vaccine Candidate, Confirms Plans
2 Valneva Reports Positive End-of-Phase 2 Chikungunya Meeting
with the U.S. FDA; Sets Stage for Phase 3 Study
3 WHO, PAHO
4 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 Awarded FDA Fast Track Designation for Chikungunya
vaccine candidate
7 Company estimate supported by an independent market study
8 Hallengärd et al. 2013, J. Virology 88:2858-2866.
- 2020_06_02_Valneva_Lancet_Publication_PR_EN_Final
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