Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2
Booster Results for Lyme Disease Vaccine Candidate
- Strong immune response shown in both children and adolescents
one month after booster dose (month 19) in VLA15-221 study
- Previously observed high anamnestic antibody response in adults
confirmed
- VLA15 well-tolerated in all age groups following booster
dose
Saint-Herblain (France)
& New York,
September 7, 2023 – Valneva SE
(Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE)
announced today positive pediatric and adolescent immunogenicity
and safety data for their Lyme disease vaccine candidate, VLA15,
when given as a booster. These results from the VLA15-221 Phase 2
study showed a strong anamnestic antibody response for all
serotypes in pediatric (5 to 11 years of age) and adolescent
participants (12 to 17 years of age), as well as in adults (18 to
65 years of age), one month after administration of a booster dose
(month 19).
Depending on the primary schedule they received
(month 0-2-6 or month 0-6), participants seroconverted after the
booster dose, yielding seroconversion1 rates (SCRs) of 95.3% and
94.6% for all outer surface protein A (OspA) serotypes in all age
groups, respectively. Additionally, OspA antibody titers were
significantly higher one month after the booster dose compared to
one month after the primary schedule with 3.3- to 3.7-fold
increases (Geometric Mean Fold Rises) in adults, 2.0- to 2.7- fold
increases in adolescents and 2.3- to 2.5-fold increases in children
for all serotypes.
Juan Carlos Jaramillo M.D., Chief
Medical Officer of Valneva, said, “We are pleased with
these data which validate the use of a booster dose in all age
groups. Lyme disease continues to spread, representing an important
unmet medical need that impacts the lives of many people in the
Northern Hemisphere. With each new set of positive data, we come
one step closer to potentially bringing this vaccine to both adults
and children living in areas where Lyme disease is endemic.”
The Phase 2 booster results emphasize the
vaccine candidate’s potential to provide immunity against Lyme
disease in pediatric and adolescent populations. Geometric Mean
Titers (GMTs) one month following the booster dose were similarly
high for children and adolescents.
The safety and tolerability profile of VLA15
after a booster dose was consistent with previous studies as the
vaccine candidate was well-tolerated in all age groups regardless
of the primary vaccination schedule. No vaccine-related serious
adverse events (SAEs) and no safety concerns were observed by an
independent Data Safety Monitoring Board (DSMB).
“Protection against Lyme disease is important
for anyone who lives or spends time outdoors in areas where Lyme
disease is endemic. This data from the VLA15-221 study is vital to
improve our understanding of how vaccination may help to protect
both adults and children from this potentially devastating
disease,” said Annaliesa Anderson, Ph.D.,
Senior Vice President and Head Vaccine Research and
Development at Pfizer.
“We are encouraged by the positive Phase 2 results for VLA15, and,
in partnership with Valneva, look forward to continuing to study
the vaccine candidate in ongoing Phase 3 clinical trials.”
These results follow six-month antibody
persistence data in children and adults reported for the VLA15-221
study in December 20221 and positive immunogenicity and safety data
reported in April 20222.
In August 2022, Pfizer and Valneva initiated the
currently ongoing Phase 3 clinical study, Vaccine Against Lyme for
Outdoor Recreationists (VALOR) (NCT05477524), 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 (U.S.) and Europe3. A second Phase 3 study (VLA15-1012),
aiming to provide further evidence on the safety profile of VLA15
in the pediatric population, is also ongoing.
Pfizer aims to submit a Biologics License
Application (BLA) to the U.S. Food and Drug Administration (FDA)
and Marketing Authorisation Application (MAA) to the European
Medicines Agency (EMA) in 2026, subject to positive Phase 3
data.
About VLA15
There are currently no approved human vaccines
for Lyme disease, and VLA15 is the most advanced Lyme disease
vaccine candidate currently in clinical development, with a Phase 3
study 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 covers the six most common OspA
serotypes expressed by the Borrelia burgdorferi sensu lato species
that are prevalent in North America and Europe. VLA15 has
demonstrated a strong immune response and satisfactory safety
profile in pre-clinical and clinical studies so far. 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 2022.4,5 The program was granted Fast Track
designation by the U.S. FDA in July 2017.6
About Clinical Study VLA15-221
VLA15-221 is a randomized, observer-blind, placebo-controlled Phase
2 study. It is the first clinical study with VLA15 which enrolled a
pediatric population (5-17 years old).
585 healthy participants received VLA15 in two
immunization schedules (month 0-2-6 [N=190] or month 0-6 [N=187])
or three doses of placebo (month 0-2-6 [N=208]). Vaccine recipients
received VLA15 at a dose of 180 µg, which was selected based on
data generated in the two previous Phase 2 studies. The main safety
and immunogenicity readout was performed one month after the
primary vaccination series. All eligible subjects received a
booster dose of VLA15 or placebo at month 18 (booster phase) and
will be followed for three additional years to monitor antibody
persistence. In addition, all eligible subjects will be asked to
receive an additional booster dose of VLA15 or placebo at month 30,
in order to generate additional data and assess the need for
periodic booster doses.
VLA15 is tested as an alum-adjuvanted
formulation and administered intramuscularly. The study is being
conducted at U.S. sites located in areas where Lyme disease is
endemic and has enrolled both volunteers with a prior infection
with Borrelia burgdorferi as well as Borrelia burgdorferi-naïve
volunteers.
About Lyme Disease
Lyme disease is a systemic infection caused by
Borrelia burgdorferi bacteria transmitted to humans by the bite of
an infected Ixodes ticks.7 It is considered the most common
vector-borne illness in the Northern Hemisphere.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.9,10 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 complications affecting the skin, joints
(arthritis), the heart (carditis) or the nervous system.9 The
medical need for vaccination against Lyme disease is steadily
increasing as the geographic footprint of the disease widens.11
About Pfizer: Breakthroughs That Change Patients’
Lives
At 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
manufacture of health care products, including innovative medicines
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
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 170 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
important to investors on our website at www.Pfizer.com. In
addition, to learn more, please visit us on www.Pfizer.com and
follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube
and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as
of September 7, 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 a Lyme disease vaccine candidate, VLA15, and a
collaboration between Pfizer and Valneva for VLA15, including their
potential benefits, booster data, a Phase 3 clinical trial 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, 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 SE
We are a specialty vaccine company focused on
the development, manufacturing and commercialization of
prophylactic vaccines for infectious diseases. We take a highly
specialized and targeted approach to vaccine development by
focusing on vaccine solutions addressing unmet medical needs to
ensure we can make a difference to peoples’ lives. We apply our
deep understanding of vaccine science, including our expertise
across multiple vaccine modalities, and our established vaccine
development capabilities, to develop vaccines against diseases
which are not yet vaccine-preventable, or for which there are
limited effective treatment options. Today, we are leveraging our
expertise and capabilities to rapidly advance a broad range of
vaccines into and through the clinic, including candidates against
the chikungunya virus and Lyme disease.
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
PfizerMedia
Relations:PfizerMediaRelations@pfizer.com+1 212-733-1226
Investor Relations:IR@pfizer.com+1
212-733-4848
ValnevaLaëtitia
Bachelot-FontaineVP Global Communications & European Investor
RelationsM +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com
Joshua Drumm, Ph.D.VP Global Investor RelationsM
+1 917 815 4520joshua.drumm@valneva.com
References
- Serconversion was defined as the proportion of subjects that
changed from seronegative at baseline to seropositive or showed a
≥four-fold increase in IgG titers compared to baseline if tested
OspA seropositive at baseline.
- Valneva and Pfizer Report Six-Month Antibody Persistence Data
in Children and Adults for Lyme Disease Vaccine Candidate. December
2022. Available at:
https://valneva.com/press-release/valneva-and-pfizer-report-six-month-antibody-persistence-data-in-children-and-adults-for-lyme-disease-vaccine-candidate/
Accessed: August 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: August 2023.
- Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease
Vaccine Candidate VLA15. August 2022. Available at:
https://valneva.com/press-release/pfizer-and-valneva-initiate-phase-3-study-of-lyme-disease-vaccine-candidate-vla15/
Accessed: August 2023.
- Valneva and Pfizer Announce Collaboration to Co-Develop and
Commercialize Lyme Disease Vaccine, VLA15. April 2020. Available
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https://valneva.com/press-release/valneva-and-pfizer-announce-collaboration-to-co-develop-and-commercialize-lyme-disease-vaccine-vla15/
Accessed: August 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: August 2023.
- Valneva Receives FDA Fast track Designation for its Lyme
Disease Vaccine Candidate VLA15. July 2017. Available at:
https://valneva.com/press-release/valneva-receives-fda-fast-track-designation-for-its-lyme-disease-vaccine-candidate-vla15/
Accessed: August 2023.
- Stanek et al. 2012, The Lancet 379:461–473
- Centers for Disease Control and Prevention. Lyme Disease.
January 2021. Available at :
https ://www.cdc.gov/lyme/stats/humancases.html. Accessed:
August 2023.
- Burn L, et al. Incidence of Lyme Borreliosis in Europe from
National Surveillance Systems (2005–2020). April 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. February 2021.
Emergency Infectious Disease. 27(2).
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Tickborne Diseases. May 2022. Available
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Accessed: August 2023.
- 2023_09_07_VLA15-221_Ado_Peds_Booster_Results_PR_EN_Final
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