Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, “BioNTech”)
today announced preliminary preclinical data in mouse and non-human
primate models from their BNT162b2 mRNA-based vaccine program
against SARS-CoV-2, the virus that causes COVID-19 disease. In a
non-human primate preclinical study, immunization with BNT162b2, a
nucleoside-modified messenger RNA (modRNA) candidate, protected
rhesus macaques against SARS-CoV-2 infection. The manuscript
describing these preclinical data is available on the preprint
server bioRxiv and is concurrently undergoing scientific
peer-review for potential publication.
“Collectively, these preclinical results,
combined with our clinical data collected to date, continue to
support the promise and validity of our mRNA-based vaccine program
against SARS-CoV-2 and selection of the BNT162b2 candidate, which
we believe has the potential to prevent many millions of COVID-19
cases,” said Kathrin U. Jansen, Ph.D., Senior Vice
President and Head of Vaccine Research & Development,
Pfizer. “We are encouraged by the data thus far and
confident in our progress towards developing a safe and effective
vaccine candidate to help address this current pandemic.”
“The data we have shared today include the
characterization of our lead candidate BNT162b2 as well as key
animal studies that were the basis for our clinical programs. They
have enabled us to advance BNT162b2 into Phase 3 evaluation,” said
Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
“This is another development milestone for providing a safe and
effective potential vaccine to the global community to help end
this pandemic.”
In the preclinical study, BNT162b2 demonstrated
protective anti-viral effects in rhesus macaques, with concomitant
high neutralizing antibody titers and a TH1-biased cellular
response in rhesus macaques and mice. In a viral infection model,
macaques that received two injections with 100 µg BNT162b2 and
macaques that received saline control injections were challenged 55
days after the second immunization with a very high viral inoculum
of approximately 1 million plaque-forming units of SARS-CoV-2, via
both intranasal (nose) and intratracheal (lung) routes.
Immunization with BNT162b2 reduced viral infection with no viral
RNA detected in the lower respiratory tract of the immunized
animals, while in most non-immunized (saline) animals, there was
evidence of viral RNA.
Importantly, BNT162b2 induced potent SARS-CoV-2
neutralizing antibodies in vaccinated-macaques, and viral
antigen-specific CD4+ and CD8+ T cells. Rhesus macaques (2- to
4-year-old males) were immunized by intramuscular (IM) immunization
with 30 µg or 100 µg of BNT162b2 or saline control on Days 0 and 21
(2 doses). After two immunizations, neutralization titers
were detectable in rhesus sera with geometric mean titers of 962
(on Day 35 for the 30 µg group) or 1,689 (on Day 28 for the 100 µg
group). Neutralizing antibody titers persisted to at least day 56,
with higher geometric mean titers (GMTs) than those in a panel
of human convalescent sera. BNT162b2 vaccination elicited a high
frequency of CD4+ T cells that produced IFN-ɣ, IL-2, and TNF-α, and
almost no IL-4 producing CD4+ cells were detectable, indicating a
TH1-biased response, which is an immune profile thought to promote
vaccine safety. BNT162b2 also elicited spike-specific
IFN-ɣ-producing CD8+ T cell responses, which is thought to promote
an anti-viral effect.
In a preclinical murine model, a single IM
immunization of BNT162b2 (0.2, 1, or 5 µg) generated B- cell and T-
cell immune responses in BALB/c mice, and SARS-CoV-2 pseudovirus
neutralizing activity increased steadily to Day 28, the last day
for which titers are reported. CD4+ and CD8+ T- cells from
splenocytes isolated from BNT162b2-immunized mice were strongly
positive for IFN-ɣ and IL-2, producing high levels of the TH1
cytokines but minute amounts of TH2 cytokines, suggesting a robust,
TH1-biased T cell adaptive immune response.
Many of these preclinical data and the Phase 1
clinical results contributed to the decision by Pfizer and BioNTech
to commence the global (except for China) Phase 2/3 safety and
efficacy portion of clinical study C4591001 to
evaluate potential prevention of COVID-19 disease by BNT162b2.
The Phase 2/3 study has enrolled over 25,000 participants 18 to 85
years of age in the U.S., Argentina, and Brazil. Additional
enrollment is planned in Germany, Turkey and South Africa. The
study is an event-driven trial.
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. Assuming
clinical success, Pfizer and BioNTech are on track to seek
regulatory review for BNT162b2 as early as October 2020 and,
if regulatory authorization or approval is obtained, currently plan
to supply up to 100 million doses worldwide 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 September 9,
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 candidate BNT162b2 (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, Regeneron, 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 potential locations of sites and
participants in our Phase 2b/3 trial; the collaboration between
BioNTech and Pfizer to develop a potential COVID-19 vaccine; our
expectations regarding the potential characteristics of BNT162b2 in
our Phase 2b/3 trial and/or in commercial use based on data
observations to date; the timing for any potential emergency use
authorizations or approvals; 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 RelationsJerica Pitts+1
(212) 733-1226Jerica.pitts@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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