BioNTech to Present Clinical Data Updates Across mRNA and
Immunomodulatory Oncology Portfolio at ESMO Congress 2024
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 presentation
Asset: BNT316/ONC-392 (gotistobart)
Session title: Mini oral session 1: Gynaecological cancers
(ID 166)
Room: Burgos Auditorium - Hall 5
Presentation 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: LBA32
Date: Sunday, September 15, 2024
Lecture time: 09:10 AM – 09:15 AM CEST
Mini oral presentations
Asset: BNT113
Session title: Mini oral session: Investigational
immunotherapy
Room: Granada Auditorium - Hall 6
Presentation title: “HARE-40: A phase I/II trial of
therapeutic HPV vaccine (BNT113) in patients with HPV16 driven
carcinoma”
Presentation number: 999MO
Date: Monday, September 16, 2024
Lecture time: 11:15 AM – 11:20 AM CEST
Asset: BNT211
Session title: Proffered paper session 2: Developmental
therapeutics
Room: Salamanca Auditorium - Hall 5
Presentation 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: 611O
Date: Sunday, September 15, 2024
Lecture time: 03:45 PM – 03:55 PM CEST
Asset: BNT327/PM8002
Session title: Mini oral session: NSCLC metastatic
Room: Santander Auditorium - Hall 5
Presentation 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: 1255MO
Date: Saturday, September 14, 2024
Lecture time: 10:20 AM – 10:25 AM CEST
Asset: BNT327/PM8002
Session title: Mini oral session 2: Breast cancer,
metastatic
Room: Barcelona Auditorium - Hall 2
Presentation 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: 348MO
Date: Monday, September 16, 2024
Lecture time: 08:35 AM – 08:40 AM CEST
Posters
Asset: BNT113
Poster 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 6
Poster number: 877P
Date: Saturday, September 14, 2024
Asset: BNT314/GEN1059
Poster 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 6
Poster number: 1072TiP
Date: Saturday, September 14, 2024
Asset: BNT323/DB-1303
Poster 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 6
Poster number: 436TiP
Abstract number: 7363
Date: Monday, September 16, 2024
Asset: BNT327/PM8002
Poster 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 6
Poster number: 1692P
Date: Sunday, September 15, 2024
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.
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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,
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Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
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Investors@biontech.de
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