- Strong immunogenicity profile observed in study participants
aged 5-17 years one month after the primary vaccination
series
- Safety profile observed in pediatric participants similar to
previously reported data in adult participants
- Pediatric population to be included in planned Phase 3 trial
– expected to start in Q3 2022, subject to regulatory
approval
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty
vaccine company, and Pfizer Inc. (NYSE: PFE) today reported
positive Phase 2 pediatric data for their Lyme disease vaccine
candidate, VLA15. Based on these new results, Valneva and Pfizer
plan to proceed with inclusion of pediatric participants in their
planned Phase 3 trial. The trial will evaluate VLA15 in adults and
pediatric subjects 5 years of age and above and is expected to be
initiated in the third quarter of 2022, subject to regulatory
approval.
The Phase 2 trial, VLA15-221, is the first clinical study with
VLA15 which enrolled a pediatric population (5-17 years old). It
compared the immunogenicity and safety of VLA15 after
administration of two (at months 0 and 6) or three (at months 0, 2
and 6) primary series doses in groups aged 5-11, 12-17 and 18-65
years. In pediatric participants (5-17 years old) who received
VLA15 in either the two-dose schedule (N=93) or three-dose schedule
(N=97), VLA15 was found to be more immunogenic than in adults with
both vaccination schedules tested. These data build on the strong
immunogenicity profile already reported for adult participants
(18-65 years old) in February 20221. Like in adults, the
immunogenicity and safety data support a three-dose primary
vaccination schedule in pediatric participants in the Phase 3
study.
The safety and tolerability profile observed in the 5- to
17-year age group was similar to the previously reported profile in
adult participants. No vaccine-related serious adverse events
(SAEs) were observed.
Valneva and Pfizer plan to submit these data for publication and
presentation at a future scientific congress.
Juan Carlos Jaramillo M.D., Chief Medical Officer of
Valneva, said, “Lyme disease affects all age groups, but with
their affinity for being active outdoors, the pediatric population
is at the greatest risk of Lyme disease. These first pediatric
results are therefore extremely important and support the inclusion
of pediatric participants in our planned Phase 3 trial. In
partnership with Pfizer, we are excited to further investigate our
VLA15 vaccine candidate, which will hopefully help protect both
adults and children against Lyme disease.”
Kathrin U. Jansen, Ph.D., Senior Vice President and Head of
Vaccine Research & Development at Pfizer, said: “The
medical need for vaccination against Lyme disease is steadily
increasing as the geographic footprint of the disease widens. These
positive pediatric data mark an important step forward in the
ongoing development of VLA15, and we are excited to continue
working with Valneva to potentially help protect both adults and
children from Lyme disease.”
About VLA15 VLA15 is the only Lyme disease vaccine
candidate currently in clinical development. 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 one of the most dominant surface proteins
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 Borrelia burgdorferi sensu lato species that are
prevalent in North America and Europe. VLA15 has demonstrated a
strong immunogenicity and safety profile in pre-clinical and
clinical studies so far. The program was granted Fast Track
designation by the U.S. Food and Drug Administration (FDA) in July
20172. Valneva and Pfizer entered into a collaboration agreement in
April 2020 to co-develop VLA153.
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 at two different
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. A subset of participants will receive a
booster dose of VLA15 or placebo at month 18 (booster phase) and
will be followed for three additional years to monitor antibody
persistence.
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 cleared past 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
infected Ixodes ticks4. It is considered the most common
vector-borne illness in the Northern Hemisphere. While the true
incidence of Lyme disease is unknown, it is estimated to annually
affect approximately 476,000 people in the United States5 and
130,000 people in Europe6. 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
geographic footprint of the disease widens7.
About Valneva SE Valneva is a specialty vaccine company
focused on the development and commercialization of prophylactic
vaccines for infectious diseases with significant unmet medical
need. The Company takes a highly specialized and targeted approach
to vaccine development and then applies its deep understanding of
vaccine science to develop prophylactic vaccines addressing these
diseases. Valneva has leveraged its expertise and capabilities both
to successfully commercialize two vaccines and to rapidly advance a
broad range of vaccine candidates into and through the clinic,
including candidates against Lyme disease, the chikungunya virus
and COVID-19.
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.
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, results and completion of research, development and
clinical trials for product candidates and estimates for future
performance. 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.
Pfizer Disclosure Notice The information contained in
this release is as of April 26, 2022. 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
and a planned phase 3 clinical trial, 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, 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; 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, 2021 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.
References 1 Valneva and Pfizer Report Further Positive
Phase 2 Data for Lyme Disease Vaccine Candidate – Valneva 2 Valneva
Receives FDA Fast Track Designation for its Lyme Disease Vaccine
Candidate VLA15 3 Valneva and Pfizer Announce Collaboration to
Co-Develop and Commercialize Lyme Disease Vaccine, VLA15 4 Stanek
et al. 2012, The Lancet 379:461–473 5 Source:
https://www.cdc.gov/lyme/stats/humancases.html 6 Sykes RA, et al.
An estimate of Lyme borreliosis incidence in Western Europe.
Journal of Public Health 2017; 39(1): 74-81 7 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/
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version on businesswire.com: https://www.businesswire.com/news/home/20220426005272/en/
Valneva Laëtitia Bachelot-Fontaine VP Global
Communications & European Investor Relations M +33 (0)6 4516
7099 laetitia.bachelot-fontaine@valneva.com
Joshua Drumm, Ph.D. VP Global Investor Relations M +1 917 815
4520 joshua.drumm@valneva.com
Pfizer Media Relations: PfizerMediaRelations@pfizer.com
212-733-1226
Investor Relations: IR@pfizer.com 212-733-4848
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