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.
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.
Pfizer Contacts:Media
RelationsAmy Rose+1 (212) 733-7410Amy.rose@pfizer.com
Investor RelationsChuck Triano+1 (212)
733-3901Charles.E.Triano@Pfizer.com
BioNTech Contacts:Media
RelationsJasmina Alatovic+49 (0)6131 9084 1513 or +49 (0)151 1978
1385Media@biontech.de
Investor RelationsSylke Maas, Ph.D.+49 (0)6131
9084 1074Investors@biontech.de
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