Valneva Reports Successful Outcome of
Phase 2 Run-In for its Lyme Disease Vaccine Candidate
Based on DSMB clearance, two lead dosage
levels have been selected for ongoing Phase 2 clinical
development
Saint-Herblain (France), June 12,
2019 – Valneva SE (“Valneva” or “the Company”), a biotech
company developing and commercializing vaccines for infectious
diseases with major unmet medical needs, today announced progress
of its ongoing Phase 2 study for its leading, unique Lyme disease
vaccine candidate, VLA15, into the main study phase. An independent
Data Safety Monitoring Board (DSMB) has cleared two dosage levels
to be used for clinical development.
Valneva has previously reported initial booster
data and final Phase 1 follow-up data for VLA15, confirming that
the vaccine candidate has a favorable safety profile and was
immunogenic in all doses and formulations tested. VLA15 elicited an
excellent anamnestic response following a booster vaccination in a
time window of 12 to 15 months after initial primary
immunization1.
As part of the VLA15-201 run-in Phase, 120
subjects received one of three alum adjuvanted dose levels of VLA15
(90µg, the high dose from Phase 1, 135µg or 180µg) or placebo. The
DSMB has reviewed safety data from those subjects and has cleared
the 135µg and 180µg dosage levels for further investigation in the
main study phase.
Valneva has commenced preparations to initiate a
further Phase 2 study (VLA15-202) to evaluate an alternative
immunization schedule. The Company expects this study to commence
in the third quarter of this year.
Wolfgang Bender, MD, PhD, Chief Medical
Officer of Valneva, commented, “We are pleased that the
run-in safety data confirm our hypothesis that we can proceed with
higher doses than initially studied in Phase 1. Given the
well-understood mode of action, high anti-OspA antibody titers are
key to deliver a highly effective vaccine that will address the
significant unmet medical need arising from the increasing spread
of Lyme disease”.
Preliminary Phase 2 results (primary endpoint)
are anticipated – as previously announced – mid-2020.
About The Phase 2 Clinical Study VLA15-201
VLA15-201 is the first of two planned, parallel
Phase 2 studies. It is a randomized, observer-blind, placebo
controlled trial conducted at trial sites in the US and Europe. In
the run-in Phase, 120 subjects received one of three dosage levels
of VLA15, or placebo. Following review of safety data by an
independent Data Safety Monitoring Board, 450 subjects in the main
study phase will receive one of two selected dose levels of VLA15
(180 subjects each), or placebo (90 subjects). VLA15 will be tested
as alum adjuvanted formulation and will be administered
intramuscularly in three injections, given one month apart at Days
1, 29 and 57. Subjects will be followed for one year, with the main
immunogenicity readout one month after the third immunization on
Day 85 (Primary Endpoint). The study is enrolling healthy adults 18
to 65 years of age. Study centers will be located in areas where
Lyme disease is endemic; subjects with a cleared past infection
with Borrelia burgdorferi, the bacteria that cause Lyme disease,
will also be enrolled.
About Lyme Disease Lyme disease
is a systemic infection caused by Borrelia bacteria transmitted to
humans by infected Ixodes ticks2. It is considered the most common
vector borne illness in the Northern Hemisphere. According to the
U.S. Centers for Disease Control and Prevention (CDC),
approximately 300,000 Americans3 are diagnosed with Lyme disease
each year with at least a further 200,000 cases in Europe4. 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. Left untreated,
the disease can disseminate and cause more serious complications
affecting the joints (arthritis), the heart (carditis) or the
nervous system. The medical need for vaccination against Lyme
disease is steadily increasing as the disease footprint
widens5.
About VLA15Valneva’s vaccine
candidate, VLA15, is currently the only active vaccine program in
clinical development against Lyme disease. The program was granted
Fast Track designation by the U.S. Food and Drug Administration
(FDA) in July 20176 and Valneva reported positive Phase 1 results
in March 20187. VLA15 showed a favourable safety profile and was
immunogenic in all doses and formulations tested with good
OspA-specific IgG antibody responses against all OspA
serotypes.VLA15 is a multivalent, protein subunit vaccine that
targets the outer surface protein A (OspA) of Borrelia. It is
designed for prophylactic, active immunization against Lyme disease
aiming for protection against the majority of human pathogenic
Borrelia species. VLA15 is designed to confer protection by raising
antibodies that prevent Borreliae from migrating from ticks to
humans after a bite. The safety profile is expected to be similar
to other lipidated protein based vaccines that are approved for
active immunization in adults and children The target population
includes individuals at risk above 2 years of age living in endemic
areas, people planning to travel to endemic areas to pursue outdoor
activities and people at risk who have a history of Lyme disease
(as infection with Borrelia does not confer protective immunity
against all pathogenic Borrelia species).Vaccination with OspA was
already proven to work in the 1990s and VLA15 pre-clinical data
showed that the vaccine has the potential to provide protection
against the majority of the Borrelia species pathogenic for
humans8.
About Valneva SEValneva is a
biotech company developing and commercializing vaccines for
infectious 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 a unique vaccine against Lyme
disease. Valneva has operations in Austria, Sweden, the United
Kingdom, France, Canada and the US with approximately 480
employees. More information is available at www.valneva.com.
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
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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
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cases, you can identify forward-looking statements by words such as
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"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
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1 Valneva PR: Valneva Reports Positive Initial Booster Data and
Final Phase 1 Data for its Lyme Disease Vaccine Candidate
2 Stanek et al. 2012, The Lancet 379:461–473
3 As estimated by the CDC,
https://www.cdc.gov/lyme/stats/humancases.html.
4 Estimated from available national data. Number largely
underestimated based on WHO Europe Lyme Report as case reporting
is
highly inconsistent in Europe and many LB infections go
undiagnosed; ECDC tick-borne-diseases-meeting-report
5 New Scientist, Lyme disease is set to explode and we still
don’t have a vaccine; March 29, 2017
https://www.newscientist.com/article/mg23431195-800-lyme-disease-is-set-to-explode-and-you-cant-protect-yourself/
6 http://www.valneva.com/en/investors-media/news/2018;
7 Valneva Press Release March 19, 2018: Valneva Reports Positive
Phase I Interim Results for Its Lyme Vaccine Candidate VLA15.
8
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0113294.
- 2019_06_11_VLA_R&D_Day_PR_EN
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