- The Phase 2 study will include both adult and pediatric
subjects with an aim to support acceleration of the vaccine
candidate’s pediatric program
- VLA15 will be tested at two different schedules
(Month 0-2-6 or Month 0-6) receiving the selected dose of
180µg
- VLA15 is the only Lyme disease vaccine candidate in
active clinical development
Saint-Herblain (France) and New York,
NY, March 8, 2021 – Valneva SE
(“Valneva”), a specialty vaccine company focused on prevention of
diseases with major unmet needs, and Pfizer Inc. (NYSE: PFE) today
announced initiation of study VLA15-221. The VLA15-221 study builds
on previous positive Phase 2 studies, incorporates new dose
regimens and is anticipated to be the final Phase 2 study readout
before a decision to progress into pivotal Phase 3 studies.
As announced in December 20201, VLA15-221 is a
randomized, observer-blind, placebo-controlled Phase 2 study. It
will be the first VLA15 study to include a pediatric population
(aged 5-17 years). Overall, the study will enroll approximately 600
healthy participants (aged 5-65 years) who will receive VLA15 or
placebo. It will compare the three-dose vaccination schedule (Month
0-2-6) with a two-dose schedule (Month 0-6).
“We are excited to be part of the Lyme disease
vaccine development program with Valneva. We hope this Phase 2
trial, with a simplified schedule, will provide evidence that the
investigational vaccine can be used in populations that are at risk
of contracting Lyme disease, potentially including children age
five years and older,” said Kathrin Jansen, Senior Vice
President and Head of Pfizer Vaccine Research and
Development.
Juan Carlos Jaramillo, Chief Medical
Officer of Valneva commented, “This trial initiation marks
an important step in the development of VLA15 toward a potential
licensure. Including a pediatric population in Phase 2 means we
could, if successful, add this population to the Phase 3 research
program, to potentially offer a vaccine for Lyme disease that may
help prevent disease in both adults and children, if approved. We
are pleased that, together with our partner Pfizer, we have decided
to pursue this development while preparing for a potential Phase 3
start.”
Valneva and Pfizer entered into a collaboration
agreement in April 2020 to co-develop VLA152. Under the terms of
the agreement, first subject, first dose in this study will trigger
a milestone payment of $10 million from Pfizer to Valneva.
About VLA 15VLA15 is the only
active Lyme disease vaccine candidate in clinical development
today, and covers six serotypes that are prevalent in North America
and Europe. This investigational multivalent protein subunit
vaccine targets the outer surface protein A (OspA) of Borrelia, an
established mechanism of action for a Lyme disease vaccine. OspA is
one of the most dominant surface proteins expressed by the bacteria
when present in a tick. VLA15 has demonstrated strong
immunogenicity and safety data 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 20173. Valneva and
Pfizer announced a collaboration for VLA15’s development and
commercialization at the end of April 2020. The two companies are
working closely together on the next development steps.
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 that enrolls a
pediatric population aged 5 years and older. A total of
approximately 600 participants will receive VLA15 at two different
immunization schedules (Month 0-2-6 or Month 0-6, 200 volunteers
each) or placebo (Month 0-2-6, 200 volunteers). Vaccinees will
receive VLA15 at a dose of 180µg, which was selected based on data
generated in the two previous Phase 2 studies. The main safety and
immunogenicity readout (Primary Endpoint analysis) will be at Month
7, where peak antibody titers are expected. A subset of
participants will receive a booster dose of VLA15 or placebo at
Month 18 (Booster Phase) and will be followed up for further three
years to monitor antibody persistence.VLA15 will be tested as an
alum-adjuvanted formulation and administered intramuscularly. The
study will be conducted at sites which are located in areas where
Lyme disease is endemic and will enroll volunteers with a cleared
past infection with Borrelia burgdorferi, the bacteria that cause
Lyme disease, as well as B. burgdorferi naïve volunteers.
About Lyme Disease Lyme disease
is a systemic infection caused by Borrelia bacteria burgdorferi
sensu lato transmitted to humans by infected Ixodes ticks4. It is
considered the most common vector borne illness in the Northern
Hemisphere. According to the U.S. Centers for Disease Control and
Prevention (CDC), approximately 476,000 Americans are diagnosed and
treated for Lyme disease each year5 with at least a further 200,000
cases 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
disease footprint widens7.
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 Forward-Looking
Statements The information contained in this release is as
of March 8, 2021. 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
potential phase 3 start, 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; 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,
2020 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 SEValneva is a
specialty vaccine company focused on the development and
commercialization of prophylactic vaccines for infectious diseases
with significant unmet medical need. We take a highly specialized
and targeted approach to vaccine development, beginning with the
identification of deadly and debilitating infectious diseases that
lack a prophylactic vaccine solution and for which there are
limited therapeutic treatment options. We then apply our deep
understanding of vaccine science, including our expertise across
multiple vaccine modalities, as well as our established vaccine
development capabilities, to develop prophylactic vaccines to
address these diseases. We have leveraged our 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.
Valneva Forward-Looking
StatementsThis 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
intellectual property and operate the business without infringing
on the intellectual property rights of others, estimates for future
performance and estimates regarding anticipated operating losses,
future revenues, capital requirements and needs for additional
financing. 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 indicative of their 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. 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 ContactsMedia Contact:
Jerica Pitts+1 (347) 224-9084Jerica.Pitts@pfizer.com
Investor Contact: Bryan Dunn+1 (212)
733-8917Bryan.Dunn@pfizer.com
Valneva Investor and Media ContactsLaetitia
Bachelot-FontaineDirector Investor Relations & Corporate
CommunicationsM +33 (0)6 4516
7099investors@valneva.com |
|
# # #
1Valneva Announces Acceleration of Pediatric Development for
Lyme Disease Vaccine Candidate
2 Valneva and Pfizer Announce Collaboration to Co-Develop and
Commercialize Lyme Disease Vaccine, VLA15
3 Valneva Receives FDA Fast Track Designation for its Lyme
Disease Vaccine Candidate VLA15
4 Stanek et al. 2012, The Lancet 379:461–473
5 Source: https://www.cdc.gov/lyme/stats/humancases.html
6 Valneva Data on File: 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
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/
- 2021_03_08_VLA15_221_Initiation_PR_EN_Final
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