Saint-Herblain (France), June 3,
2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company, today announced that the results of two
Phase 2 clinical trials of Lyme disease vaccine candidate, VLA15,
were published in the peer-reviewed medical journal, The Lancet
Infectious Diseases. These trials, as well as a third Phase 2 trial
in pediatric participants, supported the design of the current
pivotal Phase 3 trial, ‘Vaccine Against Lyme for Outdoor
Recreationists’ (VALOR).
Juan Carlos Jaramillo M.D., Chief
Medical Officer of Valneva, said, “We are pleased that
these results are now fully available to the broader infectious
disease community. Lyme disease is the most prevalent vector-borne
infectious disease in North America and Europe, and we are excited
about the ongoing trials and progress towards potentially offering
a vaccine against this unmet medical need."
The article, titled “Optimization of Dose Level
and Vaccination Schedule for the VLA15 Lyme Borreliosis Vaccine
Candidate Among Healthy Adults: Two Randomized, Phase 2 Studies”
provides a detailed analysis of the VLA15-201 and VLA15-202 trial
results, which investigated different dose levels and vaccination
schedules of VLA15, a hexavalent Lyme disease vaccine candidate
targeting most prevalent Borrelia species (serotype 1-6) in North
America and Europe.
VLA15 was shown to be immunogenic across all
dose groups and vaccination schedules tested. Strongest antibody
responses across all six serotypes were exhibited at the highest
dose (180 µg) and broader vaccination intervals (Month 0,2,6).
VLA15 has shown a favorable safety and tolerability profile across
all trials to date. No safety concerns were observed by an
independent Data Safety Monitoring Board (DSMB)1,2, in any
treatment group.
Valneva and Pfizer entered into a collaboration
agreement in April 2020 to co-develop VLA15, with updates to the
terms within this agreement made in June 20223. The companies
previously reported positive results for the booster phase of trial
VLA15-2024 and a third Phase 2 trial, VLA15-2215, providing further
evidence on VLA15’s safety profile and its potential to provide
immunity against Lyme disease in adult, pediatric and adolescent
populations. The companies also aim to publish these results in a
peer-reviewed medical journal.
The Phase 3 clinical trial, VALOR, is currently
ongoing to investigate the efficacy, safety and immunogenicity of
VLA15 in participants five years of age and older in highly endemic
regions in the United States, Canada and Europe. Enrollment of
9,437 participants for the trial was completed in December
2023.
Subject to positive data, Pfizer aims to submit
a Biologic License Application to the Food and Drug Administration
and Marketing Authorization Application to the European Medicines
Agency in 2026.
About VLA15 There are currently
no approved human vaccines for Lyme disease, and VLA15 has advanced
the furthest of any Lyme vaccine candidates currently in clinical
development, with two Phase 3 trials in progress. This
investigational multivalent protein subunit vaccine uses an
established mechanism of action for a Lyme disease vaccine that
targets the outer surface protein A (OspA) of Borrelia
burgdorferi, the bacteria that cause Lyme disease. OspA is a
surface protein expressed by the bacteria when present in a tick.
Blocking OspA inhibits the bacterium’s ability to leave the tick
and infect humans. The vaccine candidate covers the six most
prevalent OspA serotypes expressed by the Borrelia burgdorferi
sensu lato species in North America and Europe.
About Lyme DiseaseLyme disease
is a systemic infection caused by Borrelia burgdorferi bacteria
transmitted to humans by the bite of infected Ixodes ticks6. It is
the most common vector-borne illness in the Northern Hemisphere7,8.
While the true incidence of Lyme disease is unknown, the Centers
for Disease Control and Prevention (CDC) has estimated that
approximately 476,000 people in the U.S. are diagnosed and treated
each year and 129,000 cases are reported annually in Europe9,10.
Early symptoms of Lyme disease (such as a gradually expanding
erythematous rash called Erythema migrans or other nonspecific
symptoms like fatigue, fever, headache, mild stiff neck, muscle and
joint pains) are often overlooked or misinterpreted. Left
untreated, the disease can disseminate and cause more serious
chronic complications affecting the skin, joints (arthritis), the
heart (carditis) or the nervous system9,10. The medical need for
vaccination against Lyme disease is steadily increasing as the
geographic footprint of the disease widens11.
About Valneva SEWe are a
specialty vaccine company that develops, manufactures, and
commercializes prophylactic vaccines for infectious diseases
addressing unmet medical needs. We take a highly specialized and
targeted approach, applying our deep expertise across multiple
vaccine modalities, focused on providing first-, best- or
only-in-class vaccine solutions.We have a strong track record,
having advanced multiple vaccines from early R&D to approvals,
and currently market three proprietary travel vaccines as well as
certain third-party vaccines leveraging our established commercial
infrastructure.Revenues from our growing commercial business help
fuel the continued advancement of our vaccine pipeline. This
includes the only Lyme disease vaccine candidate in advanced
clinical development, which is partnered with Pfizer, as well as
vaccine candidates against the Zika virus and other global public
health threats.
Valneva
Investor and Media ContactsLaetitia Bachelot-FontaineVP
Global Communications & European Investor RelationsM +33 (0)6
4516
7099laetitia.bachelot-fontaine@valneva.com |
Joshua
Drumm, Ph.D.VP Global Investor RelationsM +001 917 815
4520joshua.drumm@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, results and
completion of research, development and clinical trials for product
candidates, to regulatory approval of product candidates and review
of existing products. 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 sustained 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
and delays 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. Success in preclinical studies or earlier clinical
trials may not be indicative of results in future clinical trials.
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 Valneva and Pfizer Report Positive Phase 2 Pediatric Data for
Lyme Disease Vaccine Candidate - Valneva2 Valneva and Pfizer Report
Six-Month Antibody Persistence Data in Children and Adults for Lyme
Disease Vaccine Candidate - Valneva3 Valneva and Pfizer Enter into
an Equity Subscription Agreement and Update Terms of Collaboration
Agreement for Lyme Disease Vaccine Candidate VLA15 - Valneva4
Valneva and Pfizer Report Further Positive Phase 2 Results,
Including Booster Response, for Lyme Disease Vaccine Candidate -
Valneva5 Valneva and Pfizer Report Positive Pediatric and
Adolescent Phase 2 Booster Results for Lyme Disease Vaccine
Candidate - Valneva6 Stanek, et al. Lyme Borreliosis. 2012. The
Lancet 379:461–473.7 Burn L, et al. Incidence of Lyme Borreliosis
in Europe from National Surveillance Systems (2005–2020). 2023.
Vector Borne and Zoonotic Diseases. 23(4):156–171.8 Kugeler KJ, et
al. Estimating the frequency of Lyme disease diagnoses—United
States, 2010-2018. 2021. Emergency Infectious Disease. 27(2).9
Centers for Disease Control and Prevention. Lyme disease. Signs and
Symptoms. Available from:
https://www.cdc.gov/lyme/signs_symptoms/index.html. Accessed
September 2022.10 Steere AC, Strle F, Wormser GP, et al. Lyme
borreliosis. Nature Reviews Disease Primers. 2016;2:16090.11
Centers for Disease Control and Prevention. Understanding Lyme and
Other Tickborne Diseases. May 2022. Available from:
https://www.cdc.gov/ncezid/dvbd/media/lyme-tickborne-diseases-increasing.html.
Accessed April 2024.
- 2024_06_03_VLA15_Phase2_LancetID_PR_EN_Final
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