
BioNTech’s combo plans emerge

When BioNTech bought Biotheus in full last November it was clear that the German group had big combination plans for its PD-L1 x VEGF bispecific antibody BNT327 – and more details of its strategy are slowly emerging. One such combo got under way last year, of BNT327 with the TROP2-targeting ADC BNT325, and data are expected in 2025. BioNTech also said in its fourth-quarter earnings release on Monday that it would start several trials this year testing BNT327 alongside various ADCs, including BNT323 (HER2), BNT324 (B7-H3) and BNT326 (HER3). Since first mentioning these plans in January, a study of BNT327 plus BNT323 in advanced breast cancer has been listed on clinicaltrials.gov, and it seems that BioNTech is trying to go one better than AstraZeneca/Daiichi Sankyo’s Enhertu. While Enhertu recently got FDA approval for HER2-ultralow breast cancer, BioNTech’s trial will additionally include HER2-null patients. No details are available for the BNT324 and BNT326 combo studies, but will be eagerly awaited – as will those of additional combos, planned for 2025+, according to BioNTech’s fourth-quarter presentation. The German company previously told ApexOnco that its aim was to replace chemotherapy with ADCs as a combination partner.
BNT327 + ADCs: ongoing & planned combo trials
ADC | Target | Originator | Status |
---|---|---|---|
BNT325 | TROP2 | DualityBio | Ph1/2 in solid tumours; data due in 2025 (from 2024) |
BNT323 (trastuzumab pamirtecan) | HER2 | DualityBio | Ph1/2 in breast cancer (ER+ve or ER-ve, HER2 low, ultralow or null); to start Apr 2025 |
BNT324 | B7-H3 | DualityBio | Combo trials planned in 2025 |
BNT326 | HER3 | MediLink | Combo trials planned in 2025 |
Source: OncologyPipeline & company releases.
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