Valneva Receives
FDA Fast Track Designation for its Lyme Disease Vaccine Candidate
VLA15
-
Lyme disease is the fastest growing vector-borne
infectious disease in the United States, according to the
CDC;
-
Currently, there is no vaccine available to
protect humans against Lyme disease and VLA15 is the only candidate
in clinical development;
-
Valneva recently completed Phase I subject
enrollment and expects to announce first results in Q1 2018;
-
The Company aims to accelerate VLA15's
development and plans to initiate a Phase II trial in Q1
2018;
-
Fast track designation may offer a faster way to
market approval through frequent interactions with the
FDA
Lyon (France), July 24, 2017 -
Valneva SE ("Valneva" or "the Company"), a fully integrated,
commercial stage biotech company focused on developing innovative
lifesaving vaccines, today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation for its
Lyme disease vaccine candidate VLA15.
Fast Track designation is granted
by the FDA to products that are under development for serious
conditions and have the potential to fulfill an unmet medical need.
It is designed to facilitate the clinical development and expedite
the review of new drugs and vaccines with the intention to
accelerate the availability of promising products on the
market[1].
Thomas
Lingelbach, President and CEO of Valneva commented, "Lyme
disease affects an increasing number of people each year, many of
whom have to live with long-term sequelae that are not only
extremely difficult to treat but also represent a heavy health
economic burden. We feel privileged to advance the only active
clinical stage Lyme vaccine candidate to date and are looking
forward to working closely with the FDA and other authorities to
facilitate the development towards approval."
Valneva recently completed subject
enrollment for the ongoing Phase I study of its Lyme disease
vaccine candidate. The study is being conducted at three sites -
two in the U.S. and one in Europe (Belgium) - combining
approximately 180 subjects aged between 18 and 40 years. The
primary objective of the observer-blind, partially randomized, dose
escalation study is to evaluate the vaccine candidate's safety and
tolerability profile at different dose levels and formulations.
Immunogenicity, measured by observing IgG antibodies[2] against the
six most prevalent serotypes of Lyme borreliosis in the US and
Europe present in the vaccine, will also be monitored for different
dose groups and formulations at different time-points.
Given the steady increase in the
incidence of the disease and its spread to new territories, Valneva
is committed to accelerate the development of VLA15 as a novel
prevention against such a high-priority medical need. As such, the
company plans to initiate Phase II as early as the first quarter of
2018.
Pre-clinical data showed that
Valneva's vaccine candidate had the potential to provide protection
against the majority of Borrelia species pathogenic for
humans[3].
About Lyme
disease
Lyme disease (LD), also known as
Lyme borreliosis, is an infectious disease caused by Borrelia
bacteria which are transmitted to humans by infected ticks. Early
symptoms of Lyme disease (such as a gradually expanding
erythematous rash called Erythema migrans or more unspecific
symptoms like fatigue, fever, headache, mild stiff neck, arthralgia
or myalgia) are often overlooked or misinterpreted. When treatment
for LD is delayed or inadequate, infection with Borrelia can lead
to serious complications involving the joints, heart and central
nervous system. Each year, an estimated 300,000 US
citizens[4] and 85,000
Europeans[5] develop
Lyme disease. It was diagnosed as a separate condition for the
first time in 1975 in Old Lyme, Connecticut.
About
VLA15
VLA15 is a new hexavalent, protein
subunit-based vaccine candidate targeting the Outer Surface Protein
A (OspA) of Borrelia, the most dominant protein expressed by the
bacteria when present in a tick. By targeting the most prevalent
serotypes of Borrelia and blocking the transmission of these
Lyme-causing bacteria from the tick to the host, the vaccine has
the potential to protect from Borrelia infection in the U.S.,
Europe, and potentially worldwide. The target indication for
Valneva's vaccine candidate is the active prophylactic immunization
against Lyme disease in children and adults. The global market for
a vaccine against Lyme disease is estimated at approximately €700 -
€800 million annually[6].
About Valneva
SE
Valneva is a fully integrated,
commercial stage biotech company focused on developing innovative
lifesaving 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 shares are tradable on
Euronext-Paris, the Vienna stock exchange and Deutsche Börse's
electronic platform Xetra®. The Company
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
Valneva SE
Laetitia Bachelot Fontaine
Head of Investor Relations &
Corporate Communications
T +33 (0)2 2807 1419
M +33 (0)6 4516 7099
investors@valneva.com |
Nina Waibel
Corporate Communications Specialist
T +43 1206 201 149
M +43 6768 455 6719
Communications@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 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]https://www.fda.gov/forpatients/approvals/fast/ucm20041766.htm
[2]
Immunoglobulin G antibodies (IgG) are found in all body fluids.
They are the smallest but most common antibody (75% to 80%) of all
the antibodies in the body. IgG antibodies are essential in
fighting bacterial and viral infections.
[3]
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0113294.
[4]
http://www.cdc.gov/lyme/stats/graphs.html.
[5] Estimation
from available national data based on WHO Europe Lyme Report; ECDC
tick-borne-diseases meeting-report.
[6] Company
estimate based on independent market studies.
2017_07_24_VLA_Lyme_FDA_Fast
Track_PR_EN
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The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: VALNEVA via Globenewswire
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