- Companies advance nucleoside-modified messenger RNA (modRNA)
candidate BNT162b2, which encodes an optimized SARS-CoV-2
full-length spike glycoprotein, at a 30 µg dose level in a 2 dose
regimen into Phase 2/3 Study
- Candidate and dose level selection informed by preclinical and
clinical data obtained in Phase 1/2 studies conducted in the U.S.
(C4591001) and Germany (BNT162-01)
- The Phase 2/3 study protocol follows all the U.S. Food and Drug
Administration (FDA) guidance on clinical trial design for COVID-19
vaccine studies.
- Phase 2/3 study of up to 30,000 participants aged 18 – 85 years
started in the U.S. and expected to include approximately 120 sites
globally
- Trial regions to include areas with significant expected
SARS-CoV-2 transmission to assess whether investigational vaccine
candidate, BNT162b2, is effective in preventing COVID-19
- Assuming clinical success, Pfizer and BioNTech on track to seek
regulatory review as early as October 2020 and, if regulatory
authorization or approval is obtained, plan to supply up to 100
million doses by the end of 2020 and approximately 1.3 billion
doses by the end of 2021
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced the start of a global (except for China) Phase 2/3 safety
and efficacy clinical study to evaluate a single
nucleoside-modified messenger RNA (modRNA) candidate from their
BNT162 mRNA-based vaccine program against SARS-CoV-2.
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After extensive review of preclinical and clinical data from
Phase 1/2 clinical trials, and in consultation with the U.S. Food
and Drug Administration’s Center for Biologics Evaluation and
Research (CBER) and other global regulators, Pfizer and BioNTech
have chosen to advance their BNT162b2 vaccine candidate into the
Phase 2/3 study, at a 30 µg dose level in a 2 dose regimen.
BNT162b2, which recently received U.S. Food and Drug Administration
(FDA) Fast Track designation, encodes an optimized SARS-CoV-2 full
length spike glycoprotein (S), which is the target of virus
neutralizing antibodies.
“Our selection of the BNT162b2 vaccine candidate and its
advancement into a Phase 2/3 study are the culmination of an
extensive, collaborative and unprecedented R&D program
involving Pfizer, BioNTech, clinical investigators, and study
participants with a singular focus of developing a safe and
effective COVID-19 RNA vaccine. The Phase 2/3 study protocol
follows all the U.S. Food and Drug Administration (FDA) guidance on
clinical trial design for COVID-19 vaccine studies,” said Kathrin
U. Jansen, Ph.D., Senior Vice President and Head of Vaccine
Research & Development, Pfizer. “The initiation of the Phase
2/3 trial is a major step forward in our progress toward providing
a potential vaccine to help fight the ongoing COVID-19 pandemic,
and we look forward to generating additional data as the program
progresses.”
“Today, we are starting our late-stage global study, which will
include up to 30,000 participants. We selected BNT162b2 as our lead
candidate for this Phase 2/3 trial upon diligent evaluation of the
totality of the data generated so far. This decision reflects our
primary goal to bring a well-tolerated, highly effective vaccine to
the market as quickly as possible, while we will continue to
evaluate our other vaccine candidates as part of a differentiated
COVID-19 vaccine portfolio,” said Ugur Sahin, M.D., CEO and
Co-Founder of BioNTech. “Many steps have been taken towards this
important milestone and we would like to thank all those involved
for their extraordinary commitment.”
About the BNT162b2 Candidate
During preclinical and clinical studies of four BNT162 RNA
vaccine candidates, BNT162b1 and BNT162b2 emerged as strong
candidates based on assessments of safety and immune response.
Pfizer and BioNTech selected BNT162b2 as the candidate to progress
to a Phase 2/3 study based on the totality of available data from
our preclinical and clinical studies, including select immune
response and tolerability parameters.
In the preclinical studies, BNT162b1 and BNT162b2 candidates
induced favorable viral antigen specific CD4+ and CD8+T cell
responses, high levels of neutralizing antibody in various animal
species, and beneficial protective effects in a primate SARS-CoV-2
challenge model.
Preliminary clinical Phase 1/2 data from nearly 120 patients
demonstrated a favorable overall tolerability profile for BNT162b2,
as compared to BNT162b1, with generally mild to moderate and
transient (1-2 days) systemic events, such as fever, fatigue and
chills and no serious adverse events. Two 30 µg doses of BNT162b2
elicited neutralizing geometric mean titers (GMTs) generally
similar to the GMTs that were elicited by the BNT162b1 vaccine
candidate, as reflected in data the companies have previously
posted on a preprint server. In older adults (65-85 years of age),
two 30 µg doses, spaced three weeks apart, elicited a neutralizing
antibody GMT higher than the GMT in a panel of 38 sera from
subjects who had contracted SARS-CoV-2. BNT162b2 vaccinated human
participants displayed a favorable breadth of epitopes recognized
in T cell responses specific to the SARS-CoV-2 antigen, as compared
to the BNT162b1 candidate. BNT162b2 demonstrated concurrent
induction of high magnitude CD4+ and CD8+ T cell responses.
BNT162b2 elicited T cell responses against the receptor binding
domain (RBD) and against the remainder of the spike glycoprotein
that is not contained in the BNT162b1 vaccine candidate. The
companies believe that immune recognition of more spike T cell
epitopes may have the potential to generate more consistent
responses across diverse populations and in older adults.
The companies are continuing to collect data from the Phase 1/2
trials for all four vaccine candidates and expect to submit data on
BNT162b2 for peer review and potential publication in the near
future. In keeping with their commitment to transparency, the
companies intend to also post the manuscript on a preprint server
at that time.
About the Phase 2/3 Study
Pfizer and BioNTech finalized the Phase 2/3 study protocol in
response to feedback from global regulators, including the FDA and
the German Paul-Ehrlich-Institut. The Phase 2/3 study is an event
driven trial that is planned to enroll up to 30,000 participants
between 18 and 85 years of age. The companies plan to enroll a
diverse population, including participants in areas where there is
significant expected SARS-CoV-2 transmission.
The Phase 2/3 trial is designed as a 1:1 vaccine candidate to
placebo, randomized, observer-blinded study to obtain safety,
immune response, and efficacy data needed for regulatory review.
The trial’s primary endpoints will be prevention of COVID-19 in
those who have not been infected by SARS-CoV-2 prior to
immunization, and prevention of COVID-19 regardless of whether
participants have previously been infected by SARS-CoV-2. Secondary
endpoints include prevention of severe COVID-19 in those groups.
The study also will explore prevention of infection by SARS-CoV-2,
the virus that causes COVID-19. The primary efficacy analysis will
be an event-driven analysis based on the number of participants
with symptomatic COVID-19 disease. The trial design allows for
interim analyses and unblinded reviews by an independent external
Data Monitoring Committee.
By the end of the trial, the Phase 2/3 study is expected to be
active at approximately 120 clinical investigational sites around
the world, including 39 states across the United States and
countries including Argentina, Brazil, and Germany. Investigator
sites are selected based on factors including scientific expertise
and capabilities, the epidemiology of the disease, and prior
experience conducting clinical trials. For further information
about this trial, visit ClinicalTrials.gov using the number
NCT04368728.
Pfizer and BioNTech are committed to decreasing health
disparities in underrepresented populations through the clinical
trial process. To that end, many investigator sites are in diverse
communities that have been disproportionately affected by COVID-19
so that individuals who have been most impacted have the
opportunity to participate. The companies are also working together
with investigator sites and advocacy partners to raise awareness
about the importance of participation in this trial.
BNT162b2 remains under clinical study and is not currently
approved for distribution anywhere in the world. If the Phase 2/3
trial is successful, Pfizer and BioNTech expect to be ready to seek
Emergency Use Authorization or some form of regulatory approval as
early as October 2020. If authorization or approval is obtained,
the companies currently aim to supply globally up to 100 million
doses by the end of 2020 and approximately 1.3 billion doses by the
end of 2021.
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 150 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 July 27,
2020. 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 Pfizer’s
efforts to combat COVID-19, the collaboration between BioNTech and
Pfizer to develop a potential COVID-19 vaccine, the BNT162 mRNA
vaccine program, and modRNA candidates BNT162b2 and BNT162b1
(including qualitative assessments of available data, potential
benefits, expectations for clinical trials and timing of regulatory
submissions, and anticipated manufacturing, supply and
distribution), 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 clinical
trials, regulatory submission dates, regulatory approval dates
and/or launch dates, as well as risks associated with preliminary
data, including the possibility of unfavorable new preclinical or
clinical trial data and further analyses of existing preclinical or
clinical trial data that may be inconsistent with the data used for
selection of the BNT162b2 vaccine candidate and dose level for the
Phase 2/3 study; the risk that clinical trial data are subject to
differing interpretations and assessments, including during the
peer review/publication process, in the scientific community
generally, and by regulatory authorities; whether and when data
from the BNT162 mRNA vaccine program will be published in
scientific journal publications and, if so, when and with what
modifications; whether regulatory authorities will be satisfied
with the design of and results from these and future preclinical
and clinical studies; whether and when any biologics license and/or
emergency use authorization applications may be filed in any
jurisdictions for BNT162b2 or any other potential vaccine
candidates; 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 vaccine
candidate’s benefits outweigh its known risks and determination of
the vaccine candidate’s efficacy and, if approved, whether it 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 a vaccine, including development of products or therapies by
other companies; manufacturing capabilities or capacity, including
whether the estimated numbers of doses can be manufactured within
the projected time periods indicated; whether and when additional
supply agreements will be reached; uncertainties regarding the
ability to obtain recommendations from vaccine technical committees
and other public health authorities and uncertainties regarding the
commercial impact of any such recommendations; 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, 2019 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 BioNTech
Biopharmaceutical New Technologies is a next generation
immunotherapy company pioneering novel therapies for cancer and
other serious diseases. The Company exploits a wide array of
computational discovery and therapeutic drug platforms for the
rapid development of novel biopharmaceuticals. Its broad portfolio
of oncology product candidates includes individualized and
off-the-shelf mRNA-based therapies, innovative chimeric antigen
receptor T cells, bi-specific checkpoint immuno-modulators,
targeted cancer antibodies and small molecules. Based on its deep
expertise in mRNA vaccine development and in-house manufacturing
capabilities, BioNTech and its collaborators are developing
multiple mRNA vaccine candidates for a range of infectious diseases
alongside its diverse oncology pipeline. BioNTech has established a
broad set of relationships with multiple global pharmaceutical
collaborators, including Genmab, Sanofi, Bayer Animal Health,
Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and
Pfizer. For more information, please visit www.BioNTech.de.
BioNTech Forward-looking statements
This press release contains “forward-looking statements” of
BioNTech within the meaning of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements may include,
but may not be limited to, statements concerning: BioNTech’s
efforts to combat COVID-19; the timing to initiate clinical trials
of BNT162 and anticipated publication of data from these clinical
trials; the potential number of sites and participants in our Phase
2/3 trial; the timing for any potential emergency use
authorizations or approvals; the collaboration between BioNTech and
Pfizer to develop a potential COVID-19 vaccine; our expectations
regarding the potential characteristics of BNT162b2 in our Phase
2/3 trial and/or in commercial use based on data observations to
date, including expected advantages over BNT162b1; and the ability
of BioNTech to supply the quantities of BNT162 to support clinical
development and, if approved, market demand, including our
production estimates for 2020 and 2021. Any forward-looking
statements in this press release are based on BioNTech current
expectations and beliefs of future events, and are subject to a
number of risks and uncertainties that could cause actual results
to differ materially and adversely from those set forth in or
implied by such forward-looking statements. These risks and
uncertainties include, but are not limited to: competition to
create a vaccine for COVID-19; the ability to produce comparable
clinical results in larger and more diverse clinical trials; the
ability to effectively scale our productions capabilities; and
other potential difficulties. For a discussion of these and other
risks and uncertainties, see BioNTech’s Annual Report on Form 20-F
filed with the SEC on March 31, 2020, which is available on the
SEC’s website at www.sec.gov. All information in this press release
is as of the date of the release, and BioNTech undertakes no duty
to update this information unless required by law.
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Pfizer Contacts:
Media Relations Amy Rose +1 (212) 733-7410
Amy.rose@pfizer.com
Investor Relations Chuck Triano +1 (212) 733-3901
Charles.E.Triano@Pfizer.com
BioNTech Contacts:
Media Relations Jasmina Alatovic +49 (0)6131 9084 1513 or +49
(0)151 1978 1385 Media@biontech.de
Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084 1074
Investors@biontech.de
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