MAINZ, Germany, March 11, 2024
– BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will
present clinical trial data for selected candidates from its
oncology pipeline at the American Association for Cancer Research
(“AACR”) Annual Meeting 2024 in San Diego, California, from April
5-10, 2024. The oral and poster presentations will feature
BioNTech’s investigational mRNA-based cancer vaccine and novel
investigational antibody-drug conjugate (“ADC”) approaches.
“This year’s AACR presentations feature
candidates from our individualized and off-the-shelf mRNA cancer
vaccine platforms, including a late-breaking presentation of
longer-term follow-up data with our individualized mRNA-based
candidate autogene cevumeran in patients with pancreatic cancer,”
said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical
Officer at BioNTech. “Our investigational mRNA cancer
vaccine approaches are an important pillar in our oncology
portfolio, aimed at eliminating residual tumor foci and reducing
the tumor burden by targeting multiple antigens at once. The data
we will be sharing at AACR show how we’re delivering on our
commitment to patients through investigating novel treatment
approaches.”
Highlights of BioNTech’s clinical stage
programs to be presented at AACR Annual Meeting 2024:
- Longer-term follow-up data of
activity and immune responses of the investigator-initiated
first-in-human Phase 1 trial (NCT04161755) with the mRNA-based
individualized neoantigen-specific immunotherapy (“iNeST”)
candidate autogene cevumeran (BNT122, RO7198457) in patients with
resected pancreatic ductal adenocarcinoma (“PDAC”) will be
presented. The results of the Phase 1 trial were published in
Nature. The candidate is currently being evaluated in an ongoing
randomized Phase 2 trial (NCT05968326) in PDAC and is jointly being
developed by BioNTech and Genentech, a member of the Roche
Group.
- BioNTech will present preliminary
results on the LuCa-MERIT-1 Phase 1 trial (NCT05142189) with its
off-the-shelf, shared tumor-associated-antigen-based mRNA
therapeutic cancer vaccine candidate BNT116 in combination with
docetaxel in patients with advanced unresectable or metastatic
non-small cell lung cancer (“NSCLC”). The data show antitumor
activity, consistent induction of immune responses in heavily
pre-treated patients with advanced NSCLC, and a manageable safety
profile.
- A trial in progress poster will
inform on the global Phase 1/2a trial (NCT05914116) of the
topoisomerase-1 inhibitor-based ADC candidate BNT324/DB-1311
targeting the immune checkpoint protein B7H3 in patients with
pretreated advanced or metastatic solid tumors. The candidate is
being jointly developed by BioNTech and Duality Biologics.
BioNTech has established a diversified clinical
oncology pipeline of more than 20 clinical programs along
mRNA-based therapeutic cancer vaccines, targeted therapies
comprising cell therapies and ADCs, and novel immunomodulators in
unmet medical need solid tumor indications. These candidates are
currently being evaluated in more than 30 clinical studies,
including nine programs in advanced Phase 2 trials and two
candidates in pivotal Phase 3 trials. BioNTech is advancing the
Company’s key programs into late-stage development with the aim to
have ten or more potentially registrational trials in its oncology
pipeline by the end of 2024.
The full abstracts are available on the AACR
Annual Meeting website. Click here for further information on
BioNTech’s pipeline candidates.
Full presentation details:
Late-breaking
presentationCandidate: Autogene cevumeran (BNT122,
RO7198457)Session Title: “Cancer Vaccines: Ready for Prime
Time?”Abstract Title: “Personalized RNA neoantigen vaccines induce
long-lived CD8+ T effector cells in pancreatic cancer”Abstract
Number: CT025Date: Sunday, April 7, 2024 Time: 3:00 PM - 5:00 PM
PST
PostersCandidate: BNT116Session
Title: Phase I Clinical TrialsAbstract Title: "Preliminary results
from LuCa-MERIT-1, a first-in-human Phase I trial evaluating the
hexavalent TAA-encoding mRNA vaccine BNT116 + docetaxel in patients
with advanced non-small cell lung cancer"Location: Poster Section
48Poster Number: CT051 Date: Monday, April 8, 2024
Candidate: BNT324/DB-1311Session Title: Phase I
Clinical Trials in Progress 2Abstract Title: “A phase 1/2a,
multicenter, open-label, first-in-human study to assess the safety,
tolerability, pharmacokinetics, and preliminary antitumor activity
of DB-1311 (a B7-H3-targeting ADC) in patients with
advanced/metastatic solid tumors”Location: Poster Section 50Poster
Number: CT165Date: Monday, April 8, 2024About
BioNTech
Biopharmaceutical New Technologies (BioNTech) is
a next generation immunotherapy company pioneering novel therapies
for cancer and other serious diseases. BioNTech 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 (CAR) T cells, several protein-based therapeutics,
including bispecific immune checkpoint modulators, targeted cancer
antibodies and antibody-drug conjugate (ADC) therapeutics, as well
as 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
Duality Biologics, Fosun Pharma, Genentech, a member of the Roche
Group, Genevant, Genmab, OncoC4, Regeneron and Pfizer.
For more information, please visit
www.BioNTech.com.
BioNTech Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, including, but not be limited to,
statements concerning: the initiation, timing, progress and results
of BioNTech’s research and development programs in oncology,
including the targeted timing and number of additional potentially
registrational trials; BioNTech’s current and future preclinical
studies and clinical trials in oncology, including individualized
neoantigen specific immunotherapy (“iNeST”) autogene cevumeran
(BNT122, RO7198457) in patients with resected PDAC, mRNA cancer
vaccine candidate BNT116 in combination with docetaxel in advanced
unresectable or metastatic NSCLC, and ADC candidate BNT324/DB-1311
in advanced or metastatic solid tumors, the nature and
characterization of and timing for release of clinical data across
BioNTech’s platforms, which is subject to peer review, regulatory
review and market interpretation; the planned next steps in
BioNTech’s pipeline programs, including, but not limited to,
statements regarding timing or plans for initiation or enrollment
of clinical trials, or submission for and receipt of product
approvals with respect to BioNTech’s product candidates; the
ability of BioNTech’s mRNA technology to demonstrate clinical
efficacy outside of BioNTech’s infectious disease platform; and the
potential safety and efficacy of BioNTech’s product candidates. Any
forward-looking statements in this press release are based on
BioNTech’s 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 discussions with
regulatory agencies regarding timing and requirements for
additional clinical trials; and the ability to produce comparable
clinical results in future clinical trials. In some cases,
forward-looking statements can be identified by terminology such as
“will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,”
“anticipates,” “believes,” “estimates,” “predicts,” “potential,”
“continue,” or the negative of these terms or other comparable
terminology, although not all forward-looking statements contain
these words. The forward-looking statements in this press release
are neither promises nor guarantees, and you should not place undue
reliance on these forward-looking statements because they involve
known and unknown risks, uncertainties, and other factors, many of
which are beyond BioNTech’s control and which could cause actual
results to differ materially from those expressed or implied by
these forward-looking statements. These risks and uncertainties
include, but are not limited to: 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
preclinical and clinical data, including the data discussed in this
release, and including the possibility of unfavorable new
preclinical, clinical or safety data and further analyses of
existing preclinical, clinical or safety data; the nature of the
clinical data, which is subject to ongoing peer review, regulatory
review and market interpretation; the timing of and BioNTech’s
ability to obtain and maintain regulatory approval for BioNTech’s
product candidates; BioNTech’s and its counterparties’ ability to
manage and source necessary energy resources; BioNTech’s ability to
identify research opportunities and discover and develop
investigational medicines; the ability and willingness of
BioNTech’s third-party collaborators to continue research and
development activities relating to BioNTech’s development
candidates and investigational medicines; unforeseen safety issues
and potential claims that are alleged to arise from the use of
products and product candidates developed or manufactured by
BioNTech; BioNTech’s and its collaborators’ ability to
commercialize and market, if approved, its product candidates;
BioNTech’s ability to manage its development and expansion;
regulatory developments in the United States and other countries;
BioNTech’s ability to effectively scale BioNTech’s production
capabilities and manufacture BioNTech’s products and BioNTech’s
product candidates; risks relating to the global financial system
and markets; and other factors not known to BioNTech at this
time.
You should review the risks and uncertainties
described under the heading “Risk Factors” in BioNTech’s Report on
Form 6-K for the period ended September 30, 2023, and in subsequent
filings made by BioNTech with the SEC, which are available on the
SEC’s website at www.sec.gov. Except as required by law, BioNTech
disclaims any intention or responsibility for updating or revising
any forward-looking statements contained in this press release in
the event of new information, future developments or otherwise.
These forward-looking statements are based on BioNTech’s current
expectations and speak only as of the date
hereof.CONTACTS
Media Relations Jasmina Alatovic +49 (0)6131
9084 1513 Media@biontech.de
Investor RelationsVictoria
Meissner, M.D.+1 617 528 8293Investors@biontech.de
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