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.
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