Investor Meeting and Live Webcast on Lyme
Disease, December 12th at 12pm ET
Valneva SE ("Valneva" or "the Company"), afully integrated,
commercial stage biotech company focused on developing innovative
life-saving vaccines, today announced that its vaccine candidate
VLA15 against Lyme disease is now progressing into clinical testing
(Phase I) following the Investigational New Drug application (IND)
clearance from the Food & Drug Administration (FDA) and the
approval of the Clinical Trial Application (CTA) in Europe
(Belgium).
Currently, there is no licensed vaccine
available to protect humans against Lyme disease, a multi systemic
tick-transmitted infection that can cause serious health problems
and disabilities. Each year, an estimated 300,000 Americans and
85,000 Europeans develop Lyme disease and according to the CDC
(Centers for Disease Control and Prevention), it is the fastest
growing vector-borne infectious disease in the United States.
Valneva is developing a new hexavalent, protein
subunit-based vaccine targeting the Outer Surface Protein A (OspA)
of Borrelia. OspA is, one of the most dominant proteins expressed
by the bacteria when present in a tick. Pre-clinical data showed
that Valneva's vaccine candidate can provide protection against the
majority of Borrelia species pathogenic for humans[1].
Thomas Lingelbach, President and CEO,
and Franck Grimaud, Deputy CEO of Valneva, commented, "We
are very pleased to be able to advance our Lyme vaccine candidate
which is intended to address such an important unmet medical need.
We are committed to finding ways to accelerate the clinical
development path to licensure, given that we are conducting the
only active vaccine program in the industry."
Valneva's Phase I trial VLA15-101 is being
conducted at two sites - one in the U.S. and one in Europe
(Belgium) and will enroll 180 subjects, aged 18-40 years. The
primary objective of the single-blind, partially randomized, dose
escalation study will be to evaluate the product candidate's safety
and tolerability. Immunogenicity, measured by observing IgG
antibodies specific against six OspA serotypes, will also be
monitored for different dose groups and formulations at different
time-points.
Investor Meeting and Live Webcast in New
York, December 12th, 12pm Eastern Time
Considering the strong interest shown on the
disease by investors, shareholders and the general public, Valneva
is hosting a conference on Lyme disease in New York on December 12,
2016 to provide more detailed information on the disease and the
opportunity to develop a vaccine. The conference will be
co-presented by Prof. Stanley A. Plotkin, Emeritus Professor,
University of Pennsylvania, and Valneva's Lyme R&D experts led
by CEO Thomas Lingelbach. To register for the conference, please
visit Valneva's website (http://www.valneva.com/en/)
About Valneva SE
Valneva is a fully integrated, commercial stage
biotech company focused on developing innovative life-saving
vaccines.
The Company seeks financial returns through
focused R&D investments in promising product candidates and
growing financial contributions from commercial products, striving
towards financial self-sustainability.
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 candidates against Clostridium difficile and
Lyme Borreliosis. A variety of partnerships with leading
pharmaceutical companies complement the Company's value proposition
and include vaccines being developed using Valneva's innovative and
validated technology platforms (EB66® vaccine production cell line,
IC31® adjuvant).
Valneva is listed on Euronext-Paris and the
Vienna stock exchange and has operations in France, Austria, Great
Britain, Sweden, Canada and the US with over 400 employees. More
information is available at www.valneva.com.
Contacts
Laetitia
Bachelot-Fontaine
Teresa Pinzolits
Head of Investor
Relations Communications
Specialist
& Corporate
Communications T
+43-1-206 20-1116
T
+02-28-07-14-19 M
+43-676-84 55 67 357
M +33 (0)6 4516
7099 communications@valneva.com
investors@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]
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0113294
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