BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”)
and Pfizer Inc. (NYSE: PFE) today
announced initial data from their ongoing German
Phase 1/2, open-label, non-randomized,
non-placebo-controlled, dose-escalation trial, that is part of the
global mRNA-based vaccine program against SARS-CoV-2. The data
are available on an online preprint server at medRxiv and are
concurrently undergoing scientific peer-review for potential
publication.
The preliminary clinical results are
for the most advanced investigational vaccine candidate in Pfizer’s
and BioNTech’s BNT162 mRNA-based vaccine program against
SARS-CoV-2, BNT162b1. This vaccine candidate is a lipid
nanoparticle formulated, nucleoside-modified messenger RNA that
encodes an optimized SARS-CoV-2 receptor binding domain (RBD)
antigen. Overall, the new preliminary data from this
German study support and expand upon the recently
disclosed early results from the corresponding U.S. trial with
BNT162b1.
Preliminary data for BNT162b1 in the German
Phase 1/2 trial were evaluated with a total of 60 healthy adults 18
to 55 years of age enrolled in the study. Of these 60 participants,
12 subjects per dose level (1 µg, 10 µg, 30 µg, and 50 µg; 48
participants in total) were vaccinated with BNT162b1 on day 1 and
day 22 (n=12 per prime-boost cohort, except n=11 for the 10 µg and
50 µg cohorts from day 22 on). Furthermore, 12 participants
received a single injection of 60 µg.
The vaccine elicited high, dose level-dependent
SARS-CoV-2-neutralizing titers and RBD-binding IgG concentrations
after the second dose. Day 43 SARS-CoV-2 neutralizing geometric
mean titers were in the range of 0.7-fold (1 µg) to 3.2-fold
(50 µg) compared to that of a panel of SARS-CoV-2 infection
convalescent human sera. Furthermore, sera of vaccinated subjects
displayed broadly neutralizing activity in pseudovirus
neutralization assays across a panel of sixteen SARS-CoV-2 RBD
variants represented in publicly available SARS-CoV-2 sequences and
against the newly dominant D614G strain.
In addition, the initial German trial results
demonstrate, for the first time for the BNT62b1 candidate, a
concurrent induction of high level CD4+ and CD8+ T cell
responses against the SARS-CoV-2 RBD.
The strength of T cell responses varied between
subjects. There was no clear dose level dependency of the T cell
response between 1 µg to 50 µg, indicating that stimulation and
robust expansion of T cells might be accomplished at low mRNA dose
levels.
All subjects in the prime-boost cohorts, except
for two at the lowest dose level, had CD4+ T cell responses.
Cytokine profiling of the RBD-specific CD4+ T cells demonstrated a
TH1-dominant profile for these cells. 29 of the 36 tested subjects
also mounted an RBD-specific functional, CD8+ T cell response that
was comparable to memory responses observed against cytomegalovirus
(CMV), Epstein Barr virus (EBV) and influenza virus.
Overall, the data suggested that BNT162b1 could
potentially be administered safely, with a manageable tolerability
profile. Local reactions and systemic events after injection with
BNT162b1 at all dose levels were transient, generally mild to
moderate, with occasional severe events (Grade 3) of flu-like
symptoms and injection site reactions. All adverse events resolved
spontaneously and were managed with simple measures. No serious
adverse events (SAEs) were reported, and there were no withdrawals
due to adverse events related to the vaccine.
“It is encouraging that the data on
BNT162b1 from the German study cohort are very much in
line with what we have seen in the U.S. study cohort. The
preliminary data indicate that our mRNA-based vaccine was able to
stimulate antibody as well as T-cell responses at remarkably low
dose levels. We believe both may play an important role in
achieving effective clearance of a pathogen such as SARS-CoV-2,”
said Özlem Türeci, M.D., CMO and Co-founder
of BioNTech.
“These interim results from the German study,
combined with initial data from the U.S. study, highlight the
potential of this mRNA-based vaccine approach and represent an
important step forward in our development efforts for the BNT162
program,” said Kathrin U. Jansen, Ph.D., Senior Vice
President and Head of Vaccine Research & Development,
Pfizer. “We remain dedicated to developing an effective
vaccine to fight the COVID-19 pandemic, with safety at the
forefront and look forward to sharing additional data as the
program progresses.”
Preliminary data from both the German and U.S.
Phase 1/2 studies, together with additional preclinical and
clinical data being generated, will be used by the two companies to
determine a dose level and select among multiple vaccine candidates
to seek to progress to an anticipated large, global Phase 2b/3
safety and efficacy trial. That trial may involve up to 30,000
healthy participants and is anticipated to begin in late July 2020,
if regulatory approval is received.
The BNT162b1 candidate remains under clinical
study and is not currently approved for distribution anywhere in
the world. If the ongoing studies are successful and the vaccine
candidate receives regulatory approval, the companies expect to
manufacture up to 100 million doses by the end of 2020 and
potentially more than 1.3 billion doses by the end of 2021. In that
event, BioNTech and Pfizer would work jointly to distribute the
potential COVID-19 vaccine worldwide (excluding China, where
BioNTech has a collaboration with Fosun Pharma for BNT162 for both
clinical development and commercialization).
About Pfizer: Breakthroughs That Change
Patients’ LivesAt 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 NoticeThe
information contained in this release is as of July 20, 2020.
Pfizer assumes no obligation to update information or
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, 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 http://www.sec.gov/ and www.pfizer.com.
About BioNTechBiopharmaceutical
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
statementsThis 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 collaboration between BioNTech
and Pfizer, and BioNTech and Fosun Pharma, to develop a potential
COVID-19 vaccine; the nature of the clinical data, which is subject
to ongoing peer review, regulatory review and market
interpretation; 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 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 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 Media RelationsAmy Rose+1 (212)
733-7410Amy.Rose@Pfizer.com
Pfizer Investor RelationsChuck Triano+1 (212)
733-3901Charles.E.Triano@Pfizer.com
BioNTech Media RelationsJasmina Alatovic+49
(0)6131 9084 1513 or +49 (0)151 1978 1385Media@biontech.de
BioNTech Investor RelationsSylke Maas, Ph.D.+49
(0)6131 9084 1074Investors@biontech.de
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