Valneva Reports Positive Phase I Interim Results for Its Lyme
Vaccine Candidate VLA15
Phase I study (VLA15-101) primary endpoint
met
- No safety concerns associated with VLA15 in any treatment
group
Encouraging immunogenicity with VLA15
- VLA15 is immunogenic in all doses and formulations tested
- Good OspA-specific IgG antibody responses against all OspA
serotypes
Lyon (France), March 19, 2018 - Valneva SE
("Valneva" or "the Company"), a fully integrated, commercial stage
biotech company focused on developing innovative lifesaving
vaccines, today announced positive Phase I interim results for its
Lyme vaccine candidate, VLA15.
The primary objective of the Phase I study
VLA15-101 was to evaluate the vaccine candidate's safety and
tolerability profile at different dose levels and formulations.
Immunogenicity, measured by determining IgG antibodies against the
six most prevalent serotypes of Lyme borreliosis in the US (ST1)
and Europe (ST1 to ST6) present in the vaccine, was also monitored
for different dose groups and formulations at various
time-points.
This interim analysis for the primary and
secondary endpoints includes safety and immunogenicity data up to
Day 84 (month 3).
The study met its primary endpoint: the vaccine
candidate showed a favourable safety profile. There were very few
severe, related AEs in all treatment groups and no associated
safety concerns.
No differences in the safety profile were
observed for the adjuvanted groups compared to the non-adjuvanted
treatment groups.
The safety profile of all tested doses and
formulations is considered comparable to other licensed lipidated
recombinant vaccines or lipid-containing vaccine formulations, and
supports further clinical development for all doses and
formulations.
VLA15 was also immunogenic in all doses and
formulations tested. OspA-specific IgG antibody responses were
induced in all treatment groups and against all OspA serotypes,
with significant dose responses seen between the lowest and the
highest dose groups. VLA15 was more immunogenic in adjuvanted
treatment groups compared to non-adjuvanted treatment mMthe same
dose level. For all six OspA serotypes, IgG levels were
substantially higher after three immunizations (Day 84) compared to
after two (Day 56).
Seroconversion Rates (SCR) for the highest,
adjuvanted dose group, which is considered preferred for further
development, ranged from 71.4% to 96.4% for the different OspA
serotypes.
Wolfgang Bender, MD, PhD, Chief Medical
Officer of Valneva commented "We are extremely pleased to
report a successful first human trial for our vaccine candidate
against Lyme disease, a severe infection which affects an
increasing number of people each year. We look forward to
providing access to an effective prevention against a disease
that is too often underdiagnosed, leaving many infected people with
no or inadequate treatment and resulting in a heavy public
health and economic burden".
The Company is committed to advance its Lyme
vaccine candidate as quickly as possible into Phase II, further to
requisite dialogue with the Authorities. Phase II is currently
expected to commence in the second half of 2018.
The next clinical phase is intended to be
conducted in Lyme-endemic regions and will include people
previously infected with Borrelia burgdorferi, the bacteria that
cause Lyme disease. Further dose optimization will be
considered.
About The Phase I Clinical Study
VLA15-101
This study is a first-in-human observer-blind,
partially randomized, dose escalation Phase I study that aims to
evaluate the safety, tolerability and immunogenicity of Valneva's
vaccine candidate VLA15. The study enrolled 179 healthy adults
under 40 years of age in Europe and the U.S. who were not
previously infected with Borrelia burgdorferi. Subjects were
randomized into six treatment groups to receive one of three dose
levels either in an alum adjuvanted formulation or without
adjuvant. Study subjects were vaccinated at three occasions one
month apart (Day 0-28-56). The interim analysis for the primary and
secondary endpoints included safety and immunogenicity data up to
Day 84 (Month 3). Final safety and immunogenicity data including
one year follow-up are expected early 2019.
Additional information, including a detailed
description of the study design, eligibility criteria, and
investigator sites, is available at ClinicalTrials.gov using
identifier NCT03010228.
About Lyme disease
Lyme disease is a systemic infection caused by
Borrelia bacteria transmitted to humans by infected Ixodes
ticks[1]. It is considered the most common vector borne illness in
the Nothern Hemisphere. According to the Centers for Disease
Control and Prevention (CDC), approximately 400,000 Americans[2]
are diagnosed with Lyme disease each year with at least a further
200,000 cases in Europe[3]. 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
widens[4].
About VLA15
Valneva'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 2017[5].
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
in individuals above 2 years of age) aiming for protection against
the majority of human pathogenic Borrelia species. VLA15 is
designed to confer protection by raising antibodies that prevent
Borrelia from migrating from ticks to humans after a bite. The
anticipated safety profile is expected to be similar to other
vaccines using the same technology that have been approved for
active immunization in adults and children.
The target population includes individuals at
risk 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 humans[6].
The global market for a vaccine against Lyme
disease is currently estimated at approximately €700 - €800 million
annually.
About Valneva SE
Valneva is a fully integrated, commercial stage
biotech company focused on developing innovative life-saving
vaccines.
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 a unique vaccine against Lyme disease.
Valneva has operations in Austria, Sweden, the
United Kingdom, France, Canada and the US with over 450 employees.
More information is available at www.valneva.com.
Valneva Investor and Media Contacts
Laetitia Bachelot-Fontaine Global Head of Investor
Relations & Corporate Communications T +33 (0)2 2807 1419 M +33
(0)6 4516 7099 investors@valneva.com |
Teresa Pinzolits Corporate Communications Specialist
T +43 1206 201 116 M+43-676-845567357
Communications@valneva.com |
Valneva 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
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future revenues, capital requirements and needs for additional
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of Valneva are consistent with the forward-looking statements
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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
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protection. In light of these risks and uncertainties, there can be
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result of new information, future events, or otherwise.
[1] Stanek et al. 2012, The Lancet 379:461-473
[2] As estimated by the CDC based on reported cases in
2015
[3] 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
[4]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/
[5] http://www.valneva.com/en/investors-media/news/2018;
[6]
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0113294.
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