BioNTech to Present Clinical Data Updates for Personalized
mRNA-based and Targeted Oncology Candidates at AACR 2024
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 presentation
Candidate: 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: CT025
Date: Sunday, April 7, 2024
Time: 3:00 PM - 5:00 PM PST
Posters
Candidate: BNT116
Session Title: Phase I Clinical Trials
Abstract 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 48
Poster Number: CT051
Date: Monday, April 8, 2024
Candidate: BNT324/DB-1311
Session Title: Phase I Clinical Trials in Progress 2
Abstract 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 50
Poster Number: CT165
Date: Monday, April 8, 2024
About 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
Statements
This 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
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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
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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,
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clinical data, including the data discussed in this release, and
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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
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unforeseen safety issues and potential claims that are alleged to
arise from the use of products and product candidates developed or
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to commercialize and market, if approved, its product candidates;
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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 Relations
Victoria Meissner, M.D.
+1 617 528 8293
Investors@biontech.de
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