On April 24, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it will present data for selected assets from its diversified oncology pipeline, including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting held in Chicago, Illinois from April 25-30, 2025 (Press release, BioNTech, APR 24, 2025, View Source [SID1234652098]). The oral and poster presentations underline both the progress of BioNTech’s advanced priority oncology programs as well as the execution of the Company’s combination strategy in oncology, with first data to be presented for the combination of the PD-L1xVEGF-A bispecific antibody candidate BNT3271 plus antibody-drug conjugates ("ADCs").

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"We believe that the future standard of care for the treatment of advanced cancers will be combinations with novel immuno-oncology backbones," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Our data presentations at this year’s AACR (Free AACR Whitepaper) support our approach to combine complementary mechanisms of action with the aim of driving synergistic anti-tumor activity. The data we present indicate that we are well positioned to work towards our vision of improving outcomes for patients across the full continuum of cancer disease."

Highlights of BioNTech’s oncology programs to be presented at AACR (Free AACR Whitepaper) 2025:

BioNTech will present preclinical data characterizing the mode of action of BNT327. BNT327 is an investigational next-generation bispecific antibody combining PD-L1 checkpoint inhibition with VEGF-A neutralization. BNT327 showed a high binding affinity to PD-L1 and VEGF-A and efficient blocking of PD-1/PD-L1 and VEGF-A/VEGFR2 signaling. Anti-tumor activity superior to single PD-1/PD-L1 blockade or anti-VEGF-A treatment was observed in multiple tumor models.

First data for the combination of BNT327 with various ADC candidates, which are being jointly developed by BioNTech and Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"), will be presented. The presentation will include preclinical evaluation of BNT327 plus ADCs, showing inhibition of tumor growth that is superior to each candidate alone. Further, early clinical data of the ongoing global Phase 1/2 trial (NCT05438329) of BNT327 in combination with BNT325/DB-1305, a TROP2-targeting ADC candidate, including safety and early efficacy data, will be presented in the poster session.

BioNTech will present data from the Phase 1 clinical trial LuCa-MERIT-1 (NCT05142189) for its mRNA cancer immunotherapy candidate BNT116 in combination with the anti-PD1 cemiplimab in an oral presentation. The update includes safety and clinical activity data, along with biomarker data from a cohort of frail patients with advanced or metastatic non-small cell lung cancer ("NSCLC") who were not eligible for platinum-based chemotherapy as first-line treatment. The preliminary data showed anti-tumor activity, consistent immune response induction, and a manageable safety profile.

Preclinical data for the EpCAMx4-1BB antibody candidate BNT314/GEN1059, which is being developed in collaboration with Genmab A/S ("Genmab"), will be presented in a poster session. BNT314/GEN1059 was evaluated in combination with PD-1 inhibition in a tumor model unresponsive to each single treatment. The data showed anti-tumor activity, delayed tumor outgrowth and prolonged survival for the combination treatment compared to both single treatments. The immunomodulatory activity of BNT314/GEN1059 was further potentiated in combination with PD-1 blockade.

BioNTech has established a diversified oncology portfolio including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, comprising ADCs and cell therapies, to develop novel treatment approaches for patients living with cancer. The Company is further maturing its clinical oncology pipeline across multiple solid tumor indications, including more than 20 active Phase 2 and Phase 3 clinical trials with a strategic focus on two pan-tumor priority programs: investigational mRNA cancer immunotherapies and the next-generation immunomodulator candidate BNT327. BioNTech expects multiple data readouts in 2025 and 2026 aimed at supporting its strategy and advancing the Company towards becoming a diversified multi-product oncology company.

The full abstracts are available on the AACR (Free AACR Whitepaper) Annual Meeting website. Click here for further information on BioNTech’s pipeline assets.

Full presentation details:

Oral presentation

Asset: BNT116
Session Title: "ADCs and Immunooncology-focused Biological Approaches"
Abstract Title: "Phase I trial evaluating BNT116, a TAA-encoding mRNA vaccine, in combination with cemiplimab in frail patients with advanced non-small cell lung cancer (NSCLC)"
Abstract Number: CT013
Location: Room S100 A (Grand Ballroom A)
Date: Sunday, April 27, 2025
Time: 4:20 PM – 4:30 PM CDT

Poster presentations

Asset: BNT327 + BNT325/DB-1305
Session Title: "Combination Immunotherapies"
Abstract Title: "Activity of BNT327/PM8002 (PD-L1 x VEGF-A bispecific antibody) in combination with BNT325/DB-1305 (TROP2 ADC) in solid tumors: Early preclinical and clinical evidence to support BNT327 + ADC combinations"
Poster Number: 648 / 14
Location: Section 28
Date: Sunday, April 27, 2025
Time: 2:00 PM – 5:00 PM CDT

Asset: BNT327
Session Title: "Antibodies 3: Multi-Target Checkpoint Inhibitors and Immune Activators"
Abstract Title: "Dual PD-L1 blockade and VEGF-A neutralization with the bispecific antibody BNT327/PM8002 shows potent antitumor activity in preclinical models"
Poster Number: 6061 / 2
Location: Section 37
Date: Tuesday, April 29, 2025
Time: 2:00 PM – 5:00 PM CDT

Asset: BNT314/ GEN1059
Session Title: "Antibodies 3: Multi-Target Checkpoint Inhibitors and Immune Activators"
Abstract Title: "The combination of an EpCAMx4-1BB bispecific antibody with PD-1 blockade exhibits antitumor activity in a murine tumor model unresponsive to each individual antibody"
Poster Number: 6075 / 16
Location: Section 37
Date: Tuesday, April 29, 2025
Time: 2:00 PM – 5:00 PM CDT