- Program updates include new data for investigational CAR-T and
ex-vivo T cell therapies, a novel ADC, a FixVac off-the-shelf mRNA
cancer vaccine, and a bi-specific antibody
- New data from BioNTech’s investigational autologous CAR-T
therapy BNT211 demonstrate the potential of the Company’s
innovative approach of combining an autologous CAR-T cell therapy
targeting Claudin-6 (“CLDN6”) with a CLDN6-encoding CAR-T cell
amplifying mRNA vaccine (“CARVac”)
- First-in-human data from Phase 1/2 study with next-generation
Trop-2 targeting ADC candidate BNT325 (DB-1305) in
advanced/metastatic solid tumors show encouraging initial efficacy
signals and a manageable safety profile
- BioNTech advances key clinical programs into late-stage
development while strengthening its clinical-stage oncology
pipeline with synergistic potential
MAINZ, Germany, October 16, 2023 –
BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will
present data across its oncology pipeline, covering multiple solid
tumor types and novel mechanisms of action, at the European Society
for Molecular Oncology (“ESMO”) Congress 2023 in Madrid, Spain from
October 20-24, 2023. The updates will feature oral and poster
presentations for five candidates of BioNTech’s clinical pipeline
across the Company’s drug classes, which comprise mRNA-based
immunotherapies, cell therapies, protein-based therapeutics, and
small molecules.
“This year’s ESMO presentations underline the
potential of BioNTech’s precision medicine toolkit for the
treatment of solid tumor indications with high unmet medical need,
where many patients still remain underserved,” said Prof. Özlem
Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech.
“We aim to develop and combine innovative immunotherapies for
patients at different disease stages, which we believe could
increase the likelihood of therapeutic success, reduce the risk of
emergence of secondary resistance mechanisms, and unlock a larger
potential patient population.”
Highlights of BioNTech’s clinical stage
programs to be presented at ESMO Congress 2023:
Cell Therapies
- BioNTech will present new data of its investigational
autologous Claudin-6 (CLDN6)-directed CAR-T cell therapy BNT211
(NCT04503278), including data showing the potential of combining
these CAR-T cells with a CLDN6-encoding CAR-T cell amplifying mRNA
vaccine (“CARVac”).
- Initial data from BioNTech's first-in-human Phase 1 study with
BNT221 (NCT04625205), a personalized, autologous
neoantigen-specific T cell therapy, will be presented. The initial
results show a manageable safety profile and tumor regression in
several patients with anti-PD-1 and anti-CTLA4 pretreated advanced
or metastatic melanoma.
Protein-based Therapeutics
- The Company will present first-in-human data of BNT325
(DB-1305) (NCT05438329), a next-generation Trop-2-targeting
antibody-drug conjugate (“ADC”), which is being jointly developed
with Duality Biologics. Initial data with this candidate show
encouraging preliminary efficacy and a manageable safety profile in
patients with advanced/metastatic non-small cell lung cancer
(NSCLC).
mRNA-based immunotherapies
- A trial in progress poster will inform on the ongoing
EMPOWERVAX Lung 1 Phase 2 trial (NCT05557591), which is being
conducted together with Regeneron, evaluating the efficacy and
safety of BioNTech’s fully-owned off-the-shelf mRNA cancer vaccine
candidate BNT116 in combination with cemiplimab versus cemiplimab
alone in the first-line treatment of patients with advanced NSCLC
and PD-L1 expression ≥50%.
In addition, BioNTech will also present
pre-clinical data from its BNT314 (GEN1059) program, which is being
jointly developed with Genmab. BNT314 (GEN1059) is a novel
bispecific antibody candidate aimed at boosting antitumor immune
responses through EpCAM-dependent 4-1BB agonistic activity. In
pre-clinical studies, BNT314 (GEN1059) enhanced T-cell activation,
proliferation, and effector functions in vitro and ex vivo and
promoted antitumor activity in vivo. A Phase 1/2 trial is planned
to start by early 2024 and will assess the safety and preliminary
antitumor activity of BNT314 (GEN1059) in patients with advanced or
metastatic solid tumors.
BioNTech has established a diversified clinical
oncology pipeline of more than 25 programs in high unmet medical
need solid tumor indications in more than 30 clinical studies,
including seven programs in advanced Phase 2 studies and one
candidate in a pivotal Phase 3 study. BioNTech is advancing the
Company’s key programs into late-stage development while
strengthening its clinical-stage oncology pipeline with synergistic
potential, with the aim to deliver the next generation of oncology
breakthroughs.
The full abstracts are available on the ESMO
Congress website. Click here for further information on BioNTech’s
pipeline candidates.
Full Presentation Details:
Late-breaking presentationCandidate:
BNT211Session Title: Developmental TherapeuticsAbstract Title:
“BNT211-01: Interim results from a repeat dose escalation study of
CLDN6 CAR-T cells manufactured with an automated process ± a
CLDN6-encoding CAR-T cell-Amplifying RNA Vaccine (CARVac)”Abstract
Number: LBA35Date: Monday, October 23, 2023Time: 4:30-6:00 PM
CET
Proffered paper sessionCandidate:
BNT221Session title: Investigational ImmunotherapyAbstract Title:
“NTC-001: A phase I study to test safety and efficacy of BNT221, a
non-engineered neoantigen-specific T cell product, in patients with
advanced or metastatic melanoma”Abstract Number: 1017ODate: Monday,
October 23, 2023Time: 10:15-11:40 AM CET
PosterCandidate: BNT325 (DB-1305)Session
Title: Developmental TherapeuticsAbstract Title: “DB-1305 (a Trop-2
targeted antibody-drug-conjugate [ADC]) in patients with advanced
solid tumors: Preliminary clinical results from the Phase 1/2a
study”Poster Number: 689PDate: Monday, October 23, 2023
Candidate: BNT116Session Title: NSCLC.
metastaticAbstract Title: "A phase 2 study of cemiplimab plus
BNT116 versus cemiplimab alone in first-line treatment of patients
with advanced non-small cell lung cancer with PD-L1 expression
≥50%"Poster Number: 1503TiPDate: Monday, October 23, 2023
Candidate: BNT314 (GEN1059)Session Title:
Investigational ImmunotherapyAbstract Title: “DuoBody-EpCAMx4-1BB
mediates conditional T cell co-stimulation and promotes antitumor
activity in preclinical models”Poster Number: 1072PDate: Monday,
October 23, 2023
About BioNTechBiopharmaceutical New
Technologies (BioNTech) 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 (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, Sanofi and Pfizer.
For more information, please visit
www.BioNTech.com.
BioNTech Forward-Looking StatementsThis
press release may contain 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;
BioNTech’s current and future preclinical studies and clinical
trials in oncology, including CAR-T cell therapy candidate BNT211,
neoantigen-specific T cell therapy candidate BNT221,
Trop-2-targeting ADC candidate BNT325 (DB-1305), bispecific
antibody candidate BNT314 (GEN1059) and mRNA cancer vaccine
candidate BNT116, including statements regarding the timing of
initiation and completion of studies or trials and related
preparatory work and the availability of results; timing for
any data readouts; the registrational potential of any trial we may
initiate for our product candidates; the potential safety and
efficacy of our product candidates; and BioNTech’s anticipated
market opportunity and size for its product candidates. 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; the nature of the
clinical data, which is subject to ongoing peer review, regulatory
review and market interpretation; future commercial demand and
medical need; the availability of raw materials; competition from
other product candidates, including those with different mechanisms
of action and different manufacturing and distribution constraints,
on the basis of, among other things, efficacy, cost, convenience of
storage and distribution, breadth of approved use, side-effect
profile and durability of immune response; 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 product
candidates; the timing of and BioNTech's ability to obtain and
maintain regulatory approval for its product candidates; 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 June 30, 2023, and in subsequent
filings made by BioNTech with the U.S. Securities and Exchange
Commission (“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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