Anticipated large, global Phase 2b/3 safety and
efficacy study may begin as early as July 2020
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX,
“BioNTech”) today announced that two of the companies’ four
investigational vaccine candidates from their BNT162 mRNA-based
vaccine program (BNT162b1 and BNT162b2) being developed to help
protect against SARS-CoV-2 (the virus that causes COVID-19),
received Fast Track designation from the U.S. Food and Drug
Administration (FDA). BNT162b1 and BNT162b2 are the two most
advanced vaccine candidates in the BNT162 program currently being
evaluated in ongoing Phase 1/2 clinical studies in the United
States and Germany.
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Fast Track is a process designed to facilitate the development,
and expedite the review, of new drugs and vaccines that are
intended to treat or prevent serious conditions that have the
potential to address an unmet medical need.i This designation was
granted based on preliminary data from Phase 1/2 studies that are
currently ongoing in the United States and Germany as well as
animal immunogenicity studies. The companies released early data
from the ongoing U.S. Phase 1/2 study for the product candidate
BNT162b1 on July 1, 2020. The manuscript is available on the online
preprint server medRxiv and is concurrently undergoing scientific
peer-review for potential publication. Early data from the German
trial of BNT162b1 are expected to be released in July.
The BNT162 program is evaluating at least four experimental
vaccines, each of which represent a unique combination of messenger
RNA (mRNA) format and target antigen. BNT162b1 and BNT162b2 are
both nucleoside modified RNAs, formulated in lipid nanoparticles.
BNT162b1 encodes an optimized SARS-CoV-2 receptor-binding domain
(RBD) antigen, while BNT162b2 encodes an optimized SARS-CoV-2
full-length spike protein antigen.
“The FDA’s decision to grant these two COVID-19 vaccine
candidates Fast Track designation signifies an important milestone
in the efforts to develop a safe and effective vaccine against
SARS-CoV-2,” said Peter Honig, Senior Vice President, Global
Regulatory Affairs, Pfizer. “We look forward to continue
working closely with the FDA throughout the clinical development of
this program, Project Lightspeed, to evaluate the safety and
efficacy of these vaccine candidates.”
“We are pleased to have received Fast Track designation from the
FDA for two of our vaccine candidates and look forward to working
closely with the FDA, along with our partner Pfizer, to expedite
the clinical development path forward,” said Özlem Türeci, Chief
Medical Officer at BioNTech.
The Project Lightspeed vaccine development program is based on
BioNTech’s proprietary mRNA-based technology platforms and
supported by Pfizer’s global vaccine development capabilities. The
BNT162 vaccine candidates are undergoing clinical studies and are
not currently approved for distribution anywhere in the world.
Pfizer and BioNTech are committed to developing these novel
vaccines with pre-clinical and clinical data at the forefront of
all decision-making of both companies. Subject to regulatory
approval, the companies are expecting to start a Phase 2b/3 trial
as soon as later this month and are anticipating enrolling up to
30,000 subjects. If the ongoing studies are successful, and the
vaccine candidate receives regulatory approval, the companies
currently expect to manufacture up to 100 million doses by the end
of 2020 and potentially more than 1.2 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 13,
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 BNT162 mRNA vaccine program, and a
collaboration between BioNTech and Pfizer to develop a potential
COVID-19 vaccine, including their potential benefits, and
anticipated publication of data, manufacturing and distribution and
the expected timing of clinical trials, 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 the
possibility of unfavorable new preclinical or clinical trial data
and further analyses of existing preclinical or clinical trial
data; risks associated with preliminary data; 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 the scientific journal publications referenced
above will occur 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 applications may be filed in
any jurisdictions for any potential vaccine candidates under the
collaboration; 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 any such vaccine
candidates 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 any such vaccine candidates, 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; uncertainties regarding the ability to
obtain recommendations from vaccine technical committees and other
public health authorities regarding any such vaccine candidates 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 any expedited review resulting from Fast Track
designation; collaborations between BioNTech and Pfizer, and
BioNTech and Fosun Pharma, to develop a potential COVID-19 vaccine;
and the ability of BioNTech to supply the quantities of BNT162 to
support clinical development and, if approved, market demand. 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 and 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 has been filed with the SEC and 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.
i U.S. Food and Drug Administration Fast Track
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
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version on businesswire.com: https://www.businesswire.com/news/home/20200713005168/en/
Pfizer Media Relations Amy Rose +1 (212) 733-7410
Amy.Rose@pfizer.com
Pfizer Investor Relations Chuck Triano +1 (212) 733-3901
Charles.E.Triano@pfizer.com
BioNTech Media Relations Jasmina Alatovic +49 (0)6131
9084 1513 or +49 (0)151 1978 1385 Media@biontech.de
BioNTech Investor Relations Sylke Maas, Ph.D. +49 (0)6131
9084 1074 Investors@biontech.de
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