BioNTech to Showcase Broad Advancements in Oncology Pipeline at 2025 ASCO Annual Meeting
BioNTech ,a global biotechnology company known for pioneering mRNA-based technologies, announced that it will present significant clinical trial data from its diversified oncology pipeline at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Scheduled to take place in Chicago, Illinois, from May 30 to June 3, this year’s conference will serve as a critical platform for BioNTech to highlight the progress of several investigational therapies that span multiple therapeutic modalities, including mRNA-based immunotherapies, next-generation immunomodulators, and targeted therapies such as antibody-drug conjugates (ADCs).
According to Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer of BioNTech, the future of oncology lies in the thoughtful combination of innovative mechanisms of action that work synergistically to boost therapeutic effectiveness. “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,” said Dr. Türeci. “Our data presentations at this year’s ASCO Annual Meeting show how we aim to help shape this era.”
The data presented will showcase clinical progress with two of BioNTech’s most promising therapeutic platforms: its next-generation immunomodulators—most notably the anti-PD-L1xVEGF-A antibody BNT327—and its antibody-drug conjugate (ADC) programs, which are designed to deliver targeted cytotoxic agents directly to cancer cells.
BNT327: A Promising Dual-Targeted Immunomodulator
One of the centerpieces of BioNTech’s ASCO presentations is BNT327, a novel immunomodulatory antibody designed to block both PD-L1 and VEGF-A pathways. By simultaneously inhibiting the PD-L1 immune checkpoint and the VEGF-A signaling pathway, BNT327 aims to enhance anti-tumor responses within the tumor microenvironment—a strategy that holds promise for overcoming resistance mechanisms and amplifying clinical efficacy.
Three separate presentations will be dedicated to BNT327. These include:
- An oral presentation of first-in-human data from a Phase 2 clinical trial (NCT05918107), investigating BNT327 in combination with chemotherapy as a first-line treatment for unresectable malignant mesothelioma. This rare and aggressive cancer typically forms in the lining of the lungs or abdomen. Initial findings from the study suggest that the combination regimen demonstrates anti-tumor activity alongside a manageable safety profile—important factors that could pave the way for potential regulatory consideration if confirmed in later stages of development.
- Two poster presentations will highlight BNT327’s progress in lung cancer indications:
- ROSETTA Lung-01 (NCT06712355), a Phase 3 trial evaluating BNT327 in combination therapy for extensive-stage small cell lung cancer (ES-SCLC).
- ROSETTA Lung-02 (NCT06712316), a Phase 2/3 study targeting non-small cell lung cancer (NSCLC).
These studies underscore the potential for BNT327 to be a backbone immunomodulatory agent in multiple lung cancer subtypes, leveraging its dual mechanism of action to deliver superior therapeutic outcomes.
BNT324/DB-1311: ADC Innovation for Prostate Cancer
Another key focus at the ASCO 2025 meeting will be BioNTech’s ADC program, specifically BNT324/DB-1311, a B7H3-targeted antibody-drug conjugate developed in collaboration with Duality Biologics (DualityBio). This investigational therapy is being evaluated in an ongoing Phase 1/2 clinical trial (NCT05914116) involving patients with heavily pre-treated castration-resistant prostate cancer (CRPC)—a difficult-to-treat population with limited therapeutic options.
The ADC approach allows for selective delivery of cytotoxic agents to cancer cells expressing the B7H3 protein, minimizing damage to healthy tissues. Initial clinical data to be presented during an oral session at ASCO reveal early signs of clinical activity and a manageable safety profile, bolstering the rationale for further development. Notably, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BNT324/DB-1311 in 2024, signaling recognition of its potential to fulfill an unmet medical need in advanced prostate cancer.
BNT316/ONC-392: Advancing CTLA-4 Inhibition
BioNTech is also collaborating with OncoC4, Inc. to develop BNT316/ONC-392 (gotistobart), an investigational antibody that targets CTLA-4, another key immune checkpoint involved in regulating anti-tumor responses. Two Phase 1/2 trials are currently evaluating this compound in different cancer settings:
- PRESERVE-001 (NCT04140526) is testing BNT316 in advanced melanoma, with early data suggesting a manageable safety profile and signals of anti-tumor activity. Notably, researchers will present analyses related to overall survival (OS) and next-treatment free survival (NTFS)—a novel measure that captures the duration patients can remain off therapy, reflecting potentially durable benefits.
- PRESERVE-006 (NCT05682443) explores the drug’s utility in metastatic CRPC, another cancer where immunotherapy has historically faced challenges. Again, preliminary data are promising, showing tolerability and encouraging signs of efficacy.
Together, these studies position BNT316 as a next-generation CTLA-4 inhibitor that may offer improved safety and durability compared to existing agents.
BNT142: mRNA-Powered Bispecific Immunotherapy
Rounding out BioNTech’s ASCO presentations is BNT142, a lipid nanoparticle-formulated mRNA immunotherapy that encodes a bispecific CD3xCLDN6 T cell engager antibody. This therapy is currently being evaluated in a Phase 1/2 dose-escalation study (NCT05262530) in patients with CLDN6-positive advanced solid tumors.
In an oral presentation, BioNTech will share preliminary safety and efficacy data, which support scientific proof-of-concept for using mRNA platforms to deliver bispecific antibodies. Unlike traditional bispecifics produced through recombinant protein technologies, mRNA-based approaches offer greater manufacturing flexibility, faster iteration cycles, and the potential for tunable expression. BNT142’s early activity profile may therefore signal a new frontier for BioNTech’s platform technologies beyond vaccines and into bispecific T-cell engagement.
A Deeply Diversified Oncology Strategy
The wide range of BioNTech’s pipeline candidates being presented at ASCO 2025 is emblematic of its broader strategic shift toward becoming a multi-product oncology company. The company has over 20 active Phase 2 and Phase 3 clinical trials ongoing, targeting a broad spectrum of solid tumor types. While some programs are specific to single tumor types (e.g., prostate or lung cancer), others, such as mRNA immunotherapies and immunomodulators like BNT327, are being developed as pan-tumor therapies—with the potential to treat multiple cancers based on common molecular targets or immune pathways.
In 2025 and 2026, BioNTech anticipates a wave of critical clinical readouts that could inform regulatory filings, partnership strategies, and market launches. This next phase of development is key to validating the company’s platform diversification strategy—a transition from a COVID-19 vaccine leader to a broadly integrated oncology innovator.
By leveraging its proprietary technologies in mRNA, antibodies, and targeted delivery systems, BioNTech is well-positioned to address some of the most intractable challenges in oncology. Its presentations at the 2025 ASCO Annual Meeting underscore its determination to reshape cancer treatment through synergistic, multi-modal approaches tailored to tumor biology and patient needs.
