Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for
Lyme Disease Vaccine Candidate, VLA15
Pfizer and Valneva Complete Recruitment
for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate,
VLA15
- 9,437* participants enrolled at
sites across the U.S., Europe and Canada in areas where Lyme
disease is endemic
- Trial conclusion expected by
year-end 2025
- Pfizer aims to submit regulatory
filings in the U.S. and Europe in 2026
New York, NY, and Saint-Herblain (France), December 4,
2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq:
VALN; Euronext Paris: VLA) today announced that they have completed
recruitment for the Phase 3 trial Vaccine Against Lyme for Outdoor
Recreationists (VALOR) (NCT05477524) for Lyme disease vaccine
candidate VLA15. The trial builds on previous positive Phase 1 and
2 trial results and includes both adult and pediatric participants,
with the aim to confirm the efficacy, safety, lot consistency, and
immunogenicity of VLA15.
“We are pleased that the Phase 3 trial recruitment is complete.
Lyme disease is the most prevalent vector-borne infectious disease
in the United States and Europe, can sometimes even lead to long
lasting consequences,” said Annaliesa Anderson, Ph.D.,
Senior Vice President and Head Vaccine Research and Development,
Pfizer. “If approved, a vaccine could prevent the disease
and ease the burden of acute, severe and sometimes persistent
consequences in both adults and children. We look forward to
progressing the trial with the goal of submitting a Biologics
License Application (BLA) to the U.S. Food and Drug Administration
(FDA) and Marketing Authorization Application (MAA) to the European
Medicines Agency (EMA) in 2026, subject to positive data.”
Juan Carlos Jaramillo M.D., Chief Medical Officer of
Valneva, said: “The completion of enrollment is indeed an
important milestone in the development of a potential vaccine for
Lyme disease. VLA15 has the potential to address a high need in
North America and Europe, as it has been designed to offer coverage
for the most common circulating types of Borrelia bacteria that
cause Lyme disease in these regions. We’re excited about the
ongoing trials and the progress towards potentially offering a
vaccine against this disease which can result in debilitating
sequelae and excessive healthcare usage.”
The VALOR trial, which was initiated in August 2022, has
enrolled 9,437* participants five years of age and older, at sites
in areas where Lyme disease is highly endemic across the U.S.,
Europe and Canada. As part of the primary series, participants
receive three doses of VLA15 or a saline placebo (1:1 ratio) within
the first year, and one booster dose approximately one year after
completion of the primary immunization.
The VLA15 candidate has demonstrated a strong immune response
and had a favorable safety profile across all dose and age groups
in pre-clinical and clinical trials so far.1,2 No vaccine-related
serious adverse events (SAEs) and no safety concerns were observed
by an independent Data Safety Monitoring Board (DSMB).1,2 A second
Phase 3 trial (C4601012), aiming to provide further evidence on the
safety profile of VLA15 in the pediatric population, is also fully
recruited.
The VALOR trial is expected to be concluded by the end of 2025.
Pfizer and Valneva entered into a collaboration agreement in April
2020 to co-develop VLA15, with updates to the terms within this
agreement made in June 2022.3,4
About VLA15There are currently no approved
human vaccines for Lyme disease, and VLA15 is the most advanced
Lyme disease vaccine candidate 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 common OspA serotypes
expressed by the Borrelia burgdorferi sensu lato species
that are prevalent in North America and Europe. VLA15 is an
alum-adjuvanted formulation, administered intramuscularly and has
demonstrated a strong immune response as well as satisfactory
safety profile in pre-clinical and clinical trials so far.
About the VALOR
trialVALOR is an ongoing randomized, observer-blind,
placebo-controlled Phase 3 trial which has enrolled 9,437*
participants 5 years of age and older to receive VLA15 or a saline
placebo (1:1 ratio). As part of the primary series, participants
receive three doses of VLA15 within the first year at months 0, 2
and 5-9, and one booster dose 9-12 months after completion of the
primary immunization.5 The final primary series vaccination for
participants occurs just before the peak Lyme disease season for
the region. Participants will be followed for the occurrence of
Lyme disease. The trial is conducted at sites located in areas
where Lyme disease is highly endemic across the U.S., Canada and
Europe and has enrolled volunteers with a cleared past infection
with Borrelia burgdorferi as well as Borrelia burgdorferi naïve
volunteers.
About Lyme DiseaseLyme disease is a systemic
infection caused by Borrelia burgdorferi bacteria transmitted to
humans by the bite of an infected Ixodes ticks.6 It is considered
the most common vector-borne illness in the Northern Hemisphere.7,8
While the true incidence of Lyme disease is unknown, it is
estimated to annually affect approximately 476,000 people in the
U.S. and 129,000 people in Europe.8,9 Early symptoms of Lyme
disease (such as a gradually expanding erythematous rash called
Erythema migrans or more nonspecific 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 chronic complications affecting
the skin, joints (arthritis), the heart (carditis) or the nervous
system.9,10 The medical need for vaccination against Lyme disease
is steadily increasing as the geographic footprint of the disease
widens.11
* Number of evaluable participants
About Pfizer:
Breakthroughs That
Change Patients’
LivesAt Pfizer, we apply science and our global
resources to bring therapies to people that extend and
significantly improve their lives. We strive to set the standard
for quality, safety and value in the discovery, development and
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and vaccines. Every day, Pfizer colleagues work across developed
and emerging markets to advance wellness, prevention, treatments
and cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
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Pfizer Disclosure NoticeThe information
contained in this release is as of December 4, 2023. Pfizer assumes
no obligation to update forward-looking statements contained in
this release as the result of new information or future events or
developments.
This release contains forward-looking information about an
investigational Lyme disease vaccine candidate, VLA15, and a
collaboration between Pfizer and Valneva for VLA15, including their
potential benefits, Phase 3 clinical trials and the timing of
potential regulatory submissions, that involves substantial risks
and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for our clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, including
uncertainties relating to the time needed to accrue cases in the
Phase 3 trial and uncertainties relating to an agreement with
regulatory authorities on any modifications to the clinical trial
plan as needed, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from our clinical studies; whether and when drug
applications may be filed in any jurisdictions for VLA15; whether
and when any such applications may be approved by regulatory
authorities, which will depend on myriad factors, including making
a determination as to whether the product’s benefits outweigh its
known risks and determination of the product’s efficacy and, if
approved, whether VLA15 will be commercially successful; decisions
by regulatory authorities impacting labeling, manufacturing
processes, safety and/or other matters that could affect the
availability or commercial potential of VLA15; uncertainties
regarding the ability to obtain recommendations from vaccine
advisory or technical committees and other public health
authorities and uncertainties regarding the commercial impact of
any such recommendations; whether our collaboration with Valneva
will be successful; uncertainties regarding the impact of COVID-19
on Pfizer’s business, operations and financial results; and
competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2022 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available
at www.sec.gov/ and www.pfizer.com/.
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 either 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 two
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
world’s first vaccine against the chikungunya virus, 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 Forward-Looking StatementsThis 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. 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 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.
Media
Contacts
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Relations:PfizerMediaRelations@pfizer.com+1 212-733-1226
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Bachelot-FontaineVP Global Communications & European Investor
RelationsM +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com
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+1 917 815 4520joshua.drumm@valneva.com
References
- Valneva and Pfizer Report Positive Pediatric and Adolescent
Phase 2 Booster Results for Lyme Disease Vaccine Candidate,
September 2023. Available at:
https://valneva.com/press-release/valneva-and-pfizer-report-positive-pediatric-and-adolescent-phase-2-booster-results-for-lyme-disease-vaccine-candidate/,
Accessed: November 2023.
- Valneva and Pfizer Report Positive Phase 2 Pediatric Data for
Lyme Disease Vaccine Candidate, April 2022.Available at:
https://valneva.com/press-release/valneva-and-pfizer-report-positive-phase-2-pediatric-data-for-lyme-disease-vaccine-candidate/
Accessed: November 2023.
- Valneva and Pfizer Announce Collaboration to Co-Develop and
Commercialize Lyme Disease Vaccine, VLA15. April 2020. Available
at:
https://valneva.com/press-release/valneva-and-pfizer-announce-collaboration-to-co-develop-and-commercialize-lyme-disease-vaccine-vla15/
Accessed: November 2023.
- Valneva and Pfizer Enter into Equity Subscription Agreement and
Update Terms of Collaboration Agreement for Lyme Disease Vaccine
Candidate VLA15. June 2022. Available at:
https://valneva.com/press-release/valneva-and-pfizer-enter-into-an-equity-subscription-agreement-and-update-terms-of-collaboration-agreement-for-lyme-disease-vaccine-candidate-vla15/
Accessed: November 2023.
- ClinicalTrials.gov. An Efficacy, Safety, Tolerability,
Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent
OspA-Based Lyme Disease Vaccine (VLA15) (VALOR). July 2022.
Available from:
https://www.clinicaltrials.gov/ct2/show/NCT05477524. Accessed:
November 2023.
- Stanek et al. Lyme Borreliosis, 2012, The Lancet
379:461–473
- 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.
- Kugeler KJ, et al. Estimating the frequency of Lyme disease
diagnoses—United States, 2010-2018. 2021. Emergency Infectious
Disease. 27(2).
- Centres for Disease Control. Lyme disease. Signs and Symptoms.
Available from: https://www.cdc.gov/lyme/signs_symptoms/index.html.
Accessed: September 2022.
- Steere AC, Strle F, Wormser GP, et al. Lyme borreliosis. Nature
Reviews Disease Primers. 2016;2:16090.
- Centers for Disease Control. Understanding Lyme and Other
Tickborne Diseases. May 2022. Available from:
https://www.cdc.gov/ncezid/dvbd/media/lyme-tickborne-diseases-increasing.html
Accessed: November 2023.
- 2023_12_04_VLA15_VALOR_Recruitment_Completion_PR_EN_Final
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