BioNTech to Present Clinical Data Updates for Next-Generation
Immunotherapy Candidates at the ASCO Annual Meeting 2024
MAINZ, Germany, May 21, 2024 – BioNTech
SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present
clinical trial data for selected programs from the Company’s
diversified immuno-oncology pipeline at the American Society of
Clinical Oncology (“ASCO”) Annual Meeting in Chicago, Illinois,
from May 31 to June 4, 2024. Moreover, in support of the Company’s
ongoing CAR-T cell and individualized mRNA programs, BioNTech will
also present epidemiological and real-world data from two
observational studies in patient populations for which product
candidates are being developed in the Company’s respective clinical
programs.
“Our aim is to develop innovative treatment
options across the continuum of cancer disease and establish new
treatment paradigms that have the potential to address the
fundamental challenges of treating cancer to drive meaningful
improvements in the long-term survival rates for patients,” said
Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer
at BioNTech. “The data from the interventional and
observational studies that we will present at this year’s ASCO are
of relevance for progress towards our goal as they will contribute
to informing the direction of further development of several of our
priority product candidates as well as the design of planned
pivotal and later-stage clinical trials across all three key
pillars of our diversified oncology pipeline, including novel
immunomodulators, targeted therapies such as cell therapies and
ADCs, and mRNA-based therapeutic cancer vaccines.”
Highlights of BioNTech’s updates to be
presented at the ASCO Annual Meeting 2024:
- Updates on several Phase 1b/2a
trials investigating BNT327/PM8002 as a monotherapy in patients
with solid tumors will be presented. BNT327/PM8002 is a bispecific
antibody candidate combining PD-L1 checkpoint inhibition with
VEGF-A neutralization to create a cycle of vascular normalization
and immunostimulation in the microenvironment of the tumor. Two
posters will provide clinical data updates for cohorts with
advanced cervical cancer, platinum-resistant recurrent ovarian
cancer and advanced non-small cell lung cancer (“NSCLC”). The
product candidate is being developed in collaboration with Biotheus
Inc. (“Biotheus”).
- Initial results from the
randomized, open-label, Phase 2 trial (NCT05117242) with the
bispecific antibody candidate BNT311/GEN1046 (acasunlimab) alone or
in combination with pembrolizumab in patients with previously
treated metastatic NSCLC (“mNSCLC”) will be presented.
BNT311/GEN1046 combines PD-L1 checkpoint inhibition with 4-1BB
costimulatory activation. The product candidate is being developed
in collaboration with Genmab S/A (“Genmab”).
- BioNTech will present preliminary
data of an epidemiological study (NCT04813627) that correlates
post-operative circulating tumor DNA (“ctDNA”), a cancer biomarker
for minimal residual disease, with disease-free survival in
patients with colorectal cancer (“CRC”). This observational study
provides supportive epidemiological and prognostic data for the
ongoing interventional Phase 2 trial (NCT04486378) with the
individualized neoantigen-specific immunotherapy (“iNeST”)
candidate autogene cevumeran (BNT122, RO7198457) in ctDNA-positive,
high-risk stage II/stage III adjuvant CRC. Autogene cevumeran is
jointly being developed by BioNTech and Genentech Inc.
(“Genentech”), a member of the Roche Group.
- BioNTech will present an analysis
of real-world data that investigated the overall survival,
treatment patterns and prognostic variables of patients with
testicular germ cell tumors receiving palliative chemotherapy. This
analysis will inform the design of BioNTech’s planned pivotal trial
with the Company’s CAR-T cell therapy candidate BNT211 in patients
with germ cell tumors. BNT211 combines an autologous CAR-T cell
therapy candidate targeting the oncofetal antigen Claudin-6
(“CLDN6”) and an investigational CLDN6-encoding CAR-T cell
amplifying RNA vaccine (“CARVac”).
BioNTech has established a diversified clinical
oncology pipeline based on its modular multi-platform approach. The
Company is advancing more than 20 clinical programs in unmet
medical need solid tumor indications, including mRNA-based
immunotherapies, targeted therapies entailing cell therapies and
antibody-drug conjugates (ADCs), and novel immunomodulators. 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 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 Company aims to launch its first cancer
immunotherapy in 2026. By 2030, BioNTech plans to obtain approvals
for a total of ten cancer indications across various drug
classes.
The full abstracts will be available on the ASCO
Annual Meeting website. Click here for further information on
BioNTech’s pipeline candidates.
Full poster details:
Candidate: BNT327/PM8002
Session title: Lung Cancer—Non-Small Cell Metastatic
Abstract Title: A Phase Ib/IIa Trial to Evaluate the Safety
and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and
VEGF-A, as a Monotherapy in Patients with advanced NSCLC
Location: Hall A, Poster Board 397
Abstract Number: 8533
Date: Monday, June 3, 2024
Time: 1.30 PM-4.30 PM CDT
Candidate: BNT327/PM8002
Session title: Gynecologic Cancer
Abstract Title: Efficacy and Safety of PM8002, a Bispecific
Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients
with Solid Tumors: Clinical Data from Advanced Cervical Cancer and
Platinum-resistant Recurrent Ovarian Cancer Cohorts
Location: Hall A, Poster Board 395
Abstract Number: 5524
Date: Monday, June 3, 2024
Time: 9.00 AM-12.00 PM CDT
Candidate: BNT326/YL202
Session title: Developmental Therapeutics—Molecularly
Targeted Agents and Tumor Biology
Abstract Title: YL202/BNT326, a HER3-targeted ADC, in
patients with locally advanced or metastatic non-small cell lung
cancer and breast cancer: Preliminary results from a first-in
human phase I trial
Location: Hall A, Poster Board 179
Abstract Number: 3034
Date: Saturday, June 1, 2024
Time: 09:00 AM – 12:00 PM CDT
Candidate: BNT311/GEN1046
(acasunlimab)
Session Title: Developmental Therapeutics—Immunotherapy
Abstract Title: Acasunlimab (DuoBody-PD-L1x4-1BB) alone or
in combination with pembrolizumab (pembro) in patients (pts) with
previously treated metastatic non-small cell lung cancer (mNSCLC):
initial results of a randomized, open-label, phase 2 trial
Location: Hall A, Poster Board 12
Abstract Number: 2533
Date: Saturday, June 1, 2024
Time: 9.00 AM-12.00 PM CDT
Candidate: Autogene cevumeran (BNT122,
RO7198457)
Session Title: Gastrointestinal Cancer—Colorectal and
Anal
Abstract Title: Preliminary results correlating
post-operative ctDNA status with disease-free survival in Stage II
(high risk) / III Colorectal Cancer Patients in the BNT000-001
epidemiology study
Location: Hall A, Poster board 189
Abstract Number: 3526
Date: Saturday, June 1, 2024
Time: 1.30 PM-4.30 PM CDT
Candidate: BNT211
Session Title: Genitourinary Cancer—Prostate, Testicular,
and Penile
Abstract Title: Real-world evidence of overall survival (OS)
and treatment patterns of patients (pts) with testicular germ cell
tumors (DCT) receiving palliative chemotherapy in the United
States
Location: Poster board 356
Abstract Number: 5038
Date: Sunday, June 2, 2024
Time: 9.00 AM – 12.00 PM CDT
About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a global 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 and specialized pharmaceutical collaborators,
including Biotheus, DualityBio, Fosun Pharma, Genentech, a member
of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and
Regeneron.
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 the bispecific antibody candidates
BNT311/GEN1046 (acasunlimab) in patients with mNSCLC and
BNT327/PM8002 in patients with advanced cervical cancer,
platinum-resistant recurrent ovarian cancer and advanced NSCLC,
iNeST candidate autogene cevumeran (BNT122, RO7198457) in patients
with colorectal cancer, the CAR-T cell candidate BNT211 in multiple
solid tumor types, and the ADC candidate BNT326/YL202 in patients
with locally advanced or metastatic NSCLC and breast cancer; 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 and potential commercialization 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. 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 based on BioNTech’s current expectations and beliefs of
future events, and are neither promises nor guarantees. 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 and adversely
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,
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obtain and maintain regulatory approval for its product candidates;
discussions with regulatory agencies regarding timing and
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and discover and develop investigational medicines; the ability and
willingness of BioNTech’s third-party collaborators to continue
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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;
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 March 31, 2024 and in subsequent
filings made by BioNTech with the SEC, which are available on the
SEC’s website at www.sec.gov. These forward-looking statements
speak only as of the date hereof. 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.
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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