- Approximately 6,000 participants 5 years of
age and older will be enrolled in Lyme disease-endemic regions in
Europe and the U.S.
Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext
Paris: VLA) today announced the initiation of a Phase 3 clinical
study, Vaccine Against Lyme for Outdoor Recreationists (VALOR)
(NCT05477524), to investigate the efficacy, safety and
immunogenicity of their investigational Lyme disease vaccine
candidate, VLA15.
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“With increasing global rates of Lyme disease, providing a new
option for people to help protect themselves from the disease is
more important than ever,” said Annaliesa Anderson, Ph.D., Senior
Vice President and Head of Vaccine Research & Development at
Pfizer. “We hope that the data generated from the Phase 3 study
will further support the positive evidence for VLA15 to date, and
we are looking forward to collaborating with the research sites
across the U.S. and Europe on this important trial."
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva,
said, “We are extremely pleased to reach this important milestone
in the development of VLA15. Lyme disease continues to spread,
representing a high unmet medical need that impacts the lives of
many in the Northern Hemisphere. We look forward to further
investigating the VLA15 candidate in Phase 3, which will take us a
step closer to potentially bringing this vaccine to both adults and
children who would benefit from it.”
The randomized, placebo-controlled, Phase 3 VALOR study is
planned to enroll approximately 6,000 participants 5 years of age
and older. The study is being conducted at up to 50 sites located
in areas where Lyme disease is highly endemic, including Finland,
Germany, the Netherlands, Poland, Sweden and the United States.
Participants will receive three doses of VLA15 180 µg or saline
placebo as a primary vaccination series followed by one booster
dose of VLA15 or saline placebo (1:1 ratio).
Data from the Phase 2 studies continue to demonstrate strong
immunogenicity in adults as well as in children, with acceptable
safety and tolerability profiles in both study populations.1,2
Pending successful completion of the Phase 3 study, Pfizer could
potentially 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
2025.
As per the terms of the collaboration agreement between Pfizer
and Valneva, Pfizer will make a $25 million milestone payment to
Valneva upon initiation of the Phase 3 study.
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
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 2022.3,4 The terms of the collaboration agreement
include a $25 million milestone payment made to Valneva upon
Pfizer’s initiation of the Phase 3 study. The program was granted
Fast Track designation by the U.S. FDA in July 2017.5
About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia
burgdorferi bacteria transmitted to humans by infected Ixodes
ticks.6 It is considered the most common vector-borne illness in
the Northern Hemisphere.7 While the true incidence of Lyme disease
is unknown, it is estimated to annually affect approximately
476,000 people in the United States and 130,000 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 complications affecting the 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.8
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 August 8,
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, 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, 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.
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.
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.
[Category: Research]
References
- Valneva. Valneva Pfizer Report Positive Phase 2 Pediatric Data
for Lyme 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: July 2022.
- Valneva. Valneva Pfizer Report Positive Phase 2 Data for Lyme
Disease Vaccine Candidate. February 2022. Available at:
https://valneva.com/press-release/valneva-and-pfizer-report-further-positive-phase-2-data-for-lyme-disease-vaccine-candidate/
Accessed: July 2022.
- Valneva. 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: July 2022 .
- Valneva. 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: July 2022.
- Valneva. 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: July 2022.
- Stanek G, Wormser GP, Gray J, et al. Lyme borreliosis. Lancet.
2012; 4;379(9814):461-73
- Gern L, Falco RC. Lyme disease. Rev Sci Tech. 2000
Apr;19(1):121-35.
- Center for Disease Control and Prevention. Lyme Disease. Data
and Surveillance. April 2021. Available at:
https://www.cdc.gov/lyme/datasurveillance/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Flyme%2Fstats%2Findex.html
Accessed July 2022.
- Sykes RA, et al. An estimate of Lyme borreliosis incidence in
Western Europe. Journal of Public Health 2017; 39(1): 74-81
- Center for Disease Control and Prevention. Lyme Disease. Signs
and Symptoms of Untreated Lyme disease. January 2021. Available at:
https://www.cdc.gov/lyme/signs_symptoms/index.html Accessed July
2022.
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Media Contacts Pfizer Media Relations:
PfizerMediaRelations@pfizer.com 212-733-1226 Investor Relations:
IR@pfizer.com 212-733-4848 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
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