MAINZ, Germany, September 05,
2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the
Company”) will present clinical trial data for selected assets from
its multi-platform oncology pipeline at the European Society for
Molecular Oncology (“ESMO”) Congress 2024 in Barcelona, Spain from
September 13-17, 2024. The oral and poster presentations will
feature programs across BioNTech’s clinical pipeline, including
mRNA-based cancer vaccines, next-generation immunomodulators and
targeted therapy approaches.
“We believe that the future of cancer treatment
will be driven by the combination of modalities, including
immunomodulators, targeted and mRNA-based therapies,” said
Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical
Officer at BioNTech. “At this year’s ESMO, we will present
data from three clinical trials with BNT327/PM8002, one of the key
backbones for our combination treatment strategy. This bispecific
antibody will be an element in multiple novel combination treatment
approaches that may open up new synergistic mechanisms of action.
Our mRNA platforms are another important component of our
combination strategy. At ESMO, we will present clinical data that
further support the proof of concept of our mRNA-based FixVac
approach, which targets non-mutated tumor-associated antigens,
showing early clinical activity across various indications.”
Highlights of BioNTech’s clinical stage
programs to be presented at ESMO Congress 2024:
- Updates on several Phase 2 and
Phase 1/2 clinical trials evaluating BNT327/PM8002
in various indications as monotherapy and in combination with
chemotherapy will be presented. BNT327/PM8002 is an investigational
bispecific antibody combining PD-L1 checkpoint inhibition with
VEGF-A neutralization for vascular normalization and
immunostimulation in the microenvironment of the tumor. Two oral
presentations and one poster will provide clinical data updates for
cohorts with advanced non-small cell lung cancer (“NSCLC”), locally
advanced/metastatic triple-negative breast cancer (“TNBC”) and
advanced renal cell carcinoma. BNT327/PM8002 is being developed in
collaboration with Biotheus Inc. (“Biotheus”).
- Preliminary data from an ongoing
clinical Phase 2 trial (NCT04534205) evaluating
BNT113 in combination with PD-1 blockade and data
from an investigator-initiated Phase 1/2 clinical trial
(NCT03418480) evaluating BNT113 as monotherapy in HPV16-driven
cancers will be presented. The data show immunogenicity and
antitumor activity in heavily pre-treated patients in several
HPV16-positive indications, including head and neck cancer, and a
manageable safety profile. BNT113 is an investigational
lipoplex-formulated uridine mRNA immunotherapy encoding E6 and E7
antigens of HPV16.
- Preliminary data of the randomized
Phase 2 clinical trial (NCT05446298) with
BNT316/ONC-392 (gotistobart), an
investigational anti-CTLA-4 antibody, in combination with
pembrolizumab in patients with platinum-resistant recurrent ovarian
cancer (“PROC”) will be presented in a late-breaking session.
BNT316/ONC-392 is being developed in collaboration with OncoC4,
Inc. (“OncoC4”).
- Follow-up data of activity and
immune responses from the ongoing first-in-human Phase 1 clinical
trial (NCT04503278) with BNT211 in patients with
relapsed/refractory CLDN6+ solid tumors will be presented. BNT211
combines autologous CAR-T cells directed against the oncofetal
antigen Claudin-6 (“CLDN6”) and an CLDN6-encoding CAR-T cell
amplifying mRNA vaccine (“CARVac”). The data update shows signs of
antitumor activity across all indications and an increased
persistence of cancer-specific CAR-T cells when combined with
CARVac, for example in patients with testicular and ovarian
cancers. The safety profile is consistent with the previously
published data of CAR-T therapies.
BioNTech has established a diversified clinical
oncology pipeline including mRNA-based therapeutic cancer vaccines,
targeted therapies comprising cell therapies and ADCs, and novel
immunomodulators in unmet medical need solid tumor indications.
These investigational treatments are currently being evaluated in
more than 32 clinical trials, including eight programs in advanced
Phase 2 trials and two assets in pivotal Phase 3 trials globally.
BioNTech is advancing the Company’s key programs into late-stage
development with the aim of having ten or more potentially
registrational trials in its oncology pipeline by the end of
2024.
The full abstracts are available on the ESMO
Congress website. Click here for further information on BioNTech’s
pipeline assets.
Full presentation details:
Late-breaking
presentationAsset: BNT316/ONC-392 (gotistobart)Session
title: Mini oral session 1: Gynaecological cancers (ID 166)Room:
Burgos Auditorium - Hall 5Presentation title: “A randomized, Phase
2, dose optimization of gotistobart, a pH-sensitive anti-CTLA-4, in
combination with standard dose pembrolizumab in platinum-resistant
recurrent ovarian cancer: safety, efficacy and dose optimization
(PRESERVE-004/GOG-3081)”Presentation number: LBA32Date: Sunday,
September 15, 2024 Lecture time: 09:10 AM – 09:15 AM CEST
Mini oral presentationsAsset:
BNT113Session title: Mini oral session: Investigational
immunotherapyRoom: Granada Auditorium - Hall 6Presentation title:
“HARE-40: A phase I/II trial of therapeutic HPV vaccine (BNT113) in
patients with HPV16 driven carcinoma”Presentation number:
999MODate: Monday, September 16, 2024 Lecture time: 11:15 AM –
11:20 AM CEST
Asset: BNT211Session title: Proffered paper
session 2: Developmental therapeuticsRoom: Salamanca Auditorium -
Hall 5Presentation title: “Updated results from BNT211-01
(NCT04503278), an ongoing, first-in-human, Phase 1 study evaluating
safety and efficacy of CLDN6 CAR T cells and a CLDN6-encoding mRNA
vaccine in patients with relapsed/refractory CLDN6+ solid
tumors”Presentation number: 611ODate: Sunday, September 15, 2024
Lecture time: 03:45 PM – 03:55 PM CEST
Asset: BNT327/PM8002Session title: Mini oral
session: NSCLC metastaticRoom: Santander Auditorium - Hall
5Presentation title: “A Phase II Safety and Efficacy Study of
PM8002/BNT327 in Combination with Chemotherapy in Patients with
EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)”Presentation
number: 1255MODate: Saturday, September 14, 2024 Lecture time:
10:20 AM – 10:25 AM CEST
Asset: BNT327/PM8002Session title: Mini oral
session 2: Breast cancer, metastaticRoom: Barcelona Auditorium -
Hall 2Presentation title: “A Phase Ib/II Study to Assess the Safety
and Efficacy of PM8002/BNT327 in Combination with Nab-Paclitaxel
for First Line Treatment of Locally Advanced or Metastatic
Triple-Negative Breast Cancer”Presentation number: 348MODate:
Monday, September 16, 2024 Lecture time: 08:35 AM – 08:40 AM
CEST
PostersAsset: BNT113Poster
title: " Exploratory efficacy and translational results from the
safety run in of AHEAD-MERIT, a phase II trial of first line
pembrolizumab plus the fixed-antigen cancer vaccine BNT113 in
advanced HPV16+ HNSCC "Room: Hall 6Poster number: 877PDate:
Saturday, September 14, 2024
Asset: BNT314/GEN1059Poster title: “Phase 1/2
dose escalation/expansion trial to evaluate safety and preliminary
efficacy of DuoBody-EpCAMx4-1BB (BNT314/GEN1059) alone or
in combination with an immune checkpoint inhibitor in patients
with malignant solid tumors”Room: Hall 6Poster number: 1072TiPDate:
Saturday, September 14, 2024
Asset: BNT323/DB-1303Poster title:
“DYNASTY-Breast02: A Phase 3 trial of BNT323/DB-1303 vs
Investigator's Choice Chemotherapy in HER2-low, Hormone
Receptor Positive, Metastatic Breast Cancer”Room: Hall 6Poster
number: 436TiPAbstract number: 7363Date: Monday, September 16,
2024
Asset: BNT327/PM8002Poster title: “A Phase
Ib/IIa Trial to Evaluate the Safety and Efficacy of PM8002/ BNT327,
a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy
in Patients with advanced renal cell carcinoma”Room: Hall 6Poster
number: 1692PDate: Sunday, September 15, 2024
About BioNTechBiopharmaceutical
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
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, including, but not 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 and its collaborators’ current
and future preclinical studies and clinical trials in oncology,
including the investigational lipoplex-formulated uridine mRNA
immunotherapy BNT113, the investigational bispecific antibodies
BNT327/PM8002 and BNT314/GEN1059, the investigational anti-CTLA-4
antibody BNT316/ONC-392 (gotistobart) in combination with
pembrolizumab, the investigational CAR-T cell therapy BNT211, and
the investigational ADC therapy BNT323/DB-1303; 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,
clinical or safety data; the nature of clinical data, which is
subject to ongoing peer review, regulatory review and market
interpretation; the ability to produce comparable clinical results
in future clinical trials; the timing of and BioNTech’s ability to
obtain and maintain regulatory approval for its product candidates;
discussions with regulatory agencies regarding timing and
requirements for additional clinical trials; 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 its production capabilities
and manufacture its products and 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 June 30, 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 RelationsVictoria
Meissner, M.D.Investors@biontech.de
BioNTech (NASDAQ:BNTX)
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