- The data further demonstrated the ability of BNT162b1 to elicit
high SARS-CoV-2 neutralizing titers
- BNT162b1 elicited strong CD4+ and CD8+ T cell responses against
SARS-CoV-2- receptor binding domain (RBD), compared to
baseline
- The RBD-specific, interferon-γ+, IL-2+, CD8+ T cells elicited
by BNT162b1 in immunized participants indicate a strong potential
for cell mediated anti-viral activity
- T cell cytokine profile shows vaccine elicited T cells exhibit
a Th1 phenotype, which is associated with antiviral properties
- BNT162b1 induced antibodies had broadly neutralizing activity
in pseudovirus neutralization assays across a panel of sixteen
SARS-CoV-2 RBD variants identified in published SARS-CoV-2
sequences and against the newly dominant D614G strain
- Robust specific antibody and T cell responses, (both of which
are considered by experts as key to a vaccine ensuring protection
against disease) elicited by the BNT162b1 mRNA vaccine against RBD
suggest a potential for multiple beneficial protective mechanisms
against COVID-19
- Local reactions and systemic events after immunization with
BNT162b1 were dose-dependent, generally mild to moderate and
transient, with occasional severe adverse events (Grade 3, e.g.
flu-like symptoms and injection site reactions) that resolved
spontaneously or could be managed with simple measures - no serious
adverse events were reported
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.
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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 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 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.
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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200720005408/en/
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
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
Pfizer (NYSE:PFE)
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