On May 27, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it will present clinical trial data from select pipeline candidates across the Company’s diversified oncology portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting, to be held in Chicago, IL, from May 30 to June 3, 2025 (Press release, BioNTech, MAY 27, 2025, View Source [SID1234653389]). The data highlight continued progress of the Company’s clinical programs consisting of complementary therapeutic modalities, including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, including antibody-drug conjugates ("ADCs").
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"We believe that the next era of cancer medicine will be defined by the interplay of complementary mechanisms and innovative molecules, unlocking their full potential through synergy. Our data presentations at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting show how we aim to help shape this era," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "We will present clinical progress with two of our therapeutic modalities: our next generation immunomodulators, most notably our investigational anti-PD-L1xVEGF-A antibody BNT327, and for one of our ADC programs, which are an important pillar of our combination strategy. These data underline the potential of our assets to improve outcomes for patients."
Highlights of BioNTech’s oncology programs to be presented at ASCO (Free ASCO Whitepaper) 2025:
•Three presentations on BNT3271, an investigational anti-PD-L1xVEGF-A antibody, will detail data from ongoing later-stage and potentially registrational clinical trials: An oral presentation will feature the first data from a Phase 2 clinical trial (NCT05918107) of BNT327 in combination with chemotherapy as first-line treatment for patients with unresectable malignant mesothelioma. Malignant mesothelioma is a type of cancer that develops in the tissue that covers the lung or the abdomen. The preliminary data indicated anti-tumor activity and a manageable safety profile. Two posters will detail the ongoing global Phase 3 and Phase 2/3 clinical trials, ROSETTA Lung-01 (NCT06712355) in extensive-stage small cell lung cancer ("ES-SCLC") and ROSETTA Lung-02 (NCT06712316) in non-small cell lung cancer ("NSCLC"). BNT327 combines the two complementary anti-tumor mechanisms of PD-L1 checkpoint and VEGF-A signaling blockade in the tumor microenvironment, thereby aiming to enhance anti-tumor activity.
•Data on BNT324/DB-1311, a B7H3-targeted ADC candidate, from an ongoing Phase 1/2 clinical trial (NCT05914116) in patients with heavily pre-treated castration-resistant prostate cancer ("CRPC") will be presented during an oral session. The data indicated early clinical activity and a manageable safety profile. BNT324/DB-1311 received Fast Track Designation by the U.S. Food & Drug Administration ("FDA") for this patient population in 2024 and is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio").
•Preliminary data on BNT316/ONC-392 (gotistobart), an investigational anti-CTLA-4 antibody, from two ongoing Phase 1/2 clinical trials evaluating the antibody candidate in combination with current standard of care treatments will be presented. Data from the PRESERVE-001 clinical trial (NCT04140526) in patients with advanced melanoma indicated a manageable safety profile and early signs of anti-tumor activity. The data included an analysis of overall survival ("OS") and an ad-hoc analysis of next-treatment free survival ("NTFS"), a measure for potential long-lasting benefit after initial treatment. Data from the PRESERVE-006 clinical trial (NCT05682443) in patients with metastatic CRPC indicated a manageable safety profile and preliminary efficacy. BNT316/ONC-392 is being developed in collaboration with OncoC4, Inc. ("OncoC4").
•Data on BNT142 from an exploratory Phase 1/2 dose finding trial (NCT05262530) in patients with CLDN6-positive advanced solid tumors will be featured in an oral presentation. BNT142 is an investigational lipid nanoparticle-formulated mRNA immunotherapy that encodes a CD3xCDLN6 T cell engager antibody. Preliminary data indicated a manageable safety profile and early signs of clinical activity, supporting scientific proof-of-concept and underscoring the potential of mRNA-encoded bispecific antibodies.
BioNTech has established a diversified oncology portfolio to develop novel treatment approaches for patients living with cancer. The Company is advancing its oncology pipeline across multiple solid tumor indications, including more than 20 active Phase 2 and 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 ASCO (Free ASCO Whitepaper) Annual Meeting website. Click here for further information on BioNTech’s pipeline assets.
Full presentation details:
Oral presentations
Asset: BNT327
Session Title: Clinical Science Symposium | Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic Malignancies
Abstract Title: First report of efficacy and safety results from a phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line (1L) treatment in unresectable malignant mesothelioma
Location: E451
Abstract Number: 8511
Date: June 3, 2025
Time: 9:45 AM – 11:15 AM CDT
Asset: BNT324/DB-1311
Session Title: Rapid Oral Abstract Session | Genitourinary Cancer—Prostate, Testicular, and Penile
Abstract Title: DB-1311/BNT324 (a novel B7H3 ADC) in patients with castrate-resistant prostate cancer (CRPC)
Location: Hall D2
Abstract Number: 5015
Date: June 1, 2025
Time: 4:30 PM – 6:00 PM CDT
Asset: BNT142
Session Title: Oral Abstract Session | Developmental Therapeutics—Immunotherapy
Abstract Title: First-in-human phase I/II trial evaluating BNT142, a first-in-class mRNA encoded, bispecific antibody targeting Claudin 6 (CLDN6) and CD3, in patients (pts) with CLDN6-positive advanced solid tumors.
Location: Hall D2
Abstract Number: 2501
Date: May 31, 2025
Time: 3:00 PM – 6:00 PM CDT
Poster Presentations
Asset: BNT327
Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Abstract Title: A global Phase 3 double-blind, randomized trial of BNT327/PM8002 plus chemotherapy (chemo) compared to atezolizumab plus chemo in patients (pts) with first-line (1L) extensive-stage small cell lung cancer (ES-SCLC)
Poster Board: #242a
Abstract Number: TPS8129
Date: May 31, 2025
Time: 1:30 PM – 4:30 PM CDT
Asset: BNT327
Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Abstract Title: Phase 2/3, global, multisite, randomized, open-label trial of BNT327/PM8002 in combination with chemotherapy (chemo) in first-line (1L) non-small cell lung cancer (NSCLC)
Poster Board: #138b
Abstract Number: TPS8670
Date: May 31, 2025
Time: 1:30 PM – 4:30 PM CDT
Asset: BNT316/ONC-392 (gotistobart)
Session Title: Melanoma/Skin Cancers
Abstract Title: Gotistobart in combination with pembrolizumab in patients with advanced melanoma who have progressed on PD-1 inhibitors with or without CTLA-4 inhibitors
Poster Board: #34
Abstract Number: 9551
Date: June 1, 2025
Time: 9:00 AM – 12:00 PM CDT
Asset: BNT316/ONC-392 (gotistobart)
Session Title: Genitourinary Cancer—Prostate, Testicular, and Penile
Abstract Title: Phase 1 study of gotistobart (BNT316/ONC-392) in combination with lutetium Lu 177 vipivotide tetraxetan (Lu 177) in patients with metastatic castration-resistant prostate cancer (mCRPC)
Poster Board: #266
Abstract Number: 5067
Date: June 2, 2025
Time: 9:00 AM – 12:00 PM CDT