BioNTech plans six new phase 3 oncology trials in 2026

BioNTech SE (NASDAQ: BNTX) announced plans to initiate six additional Phase 3 oncology clinical trials in 2026, bringing its total anticipated Phase 3 trials to 15. The company expects seven late-stage data readouts during the year as it advances its oncology pipeline toward potential product launches.

The German biotechnology company currently has more than 25 Phase 2 or 3 oncology trials ongoing, representing more than double the number from two years ago. BioNTech's oncology pipeline includes immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies targeting lung, breast, gynecologic, gastrointestinal, and genitourinary cancers.

Key 2026 milestones include late-stage trial readouts for several drug candidates. Trastuzumab pamirtecan, an antibody drug conjugate developed with partner Duality Biologics, will report Phase 2 results in HER2-expressing endometrial cancer and Phase 3 results in HER2-low breast cancer. The company also expects Phase 3 data for gotistobart in non-small cell lung cancer and Phase 3 results for BNT113 mRNA therapy in head and neck cancer.

BioNTech plans to submit a biologics license application for trastuzumab pamirtecan in HER2-expressing endometrial cancer during 2026. The company has more than ten novel-novel combination clinical trials in its pipeline, exploring pumitamig in combination with other investigational therapies.

The company held approximately €17.2 billion in cash, cash equivalents and security investments as of December 31, 2025. BioNTech anticipates a modest decline in COVID-19 vaccine revenues in 2026 compared to 2025, reflecting changing market dynamics. The company does not expect to recognize revenues from oncology product sales in 2026.

CEO Ugur Sahin will present the company's strategic update at the J.P. Morgan Healthcare Conference on January 13, 2026, according to the company statement.

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