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Biohaven to Present Phase 1 Data on FGFR3-Directed ADC at ENA 2026

Biohaven Ltd. will present new clinical data for BHV-1530, its first-in-class FGFR3-directed antibody-drug conjugate, during an oral session at the 38th EORTC-NCI-AACR Symposium in Barcelona this November. The findings highlight the drug's early efficacy and safety profile in patients with advanced solid tumors.

Biohaven to Present Phase 1 Data on FGFR3-Directed ADC at ENA 2026
Photo: Bio & News

The upcoming presentation at ENA 2026, scheduled for November 19, marks a significant milestone for the BHV1530-101 study. Researchers will share findings from the ongoing Phase 1 trial, which evaluates the drug as a monotherapy and in combination with other treatments. Unlike traditional FGFR tyrosine kinase inhibitors, which often face limitations due to class-specific toxicities like retinopathy or stomatitis, BHV-1530 utilizes a proprietary TopoIx payload designed to bypass these constraints while targeting both FGFR3-altered and wild-type overexpressing tumors.

Building on this clinical momentum, Biohaven has also launched an enrollment cohort to test BHV-1530 alongside Regeneron’s anti-PD-1 therapy, cemiplimab (Libtayo). This collaboration follows evidence that the ADC’s payload may induce immunogenic cell death, creating a potential synergy with checkpoint inhibitors. The study currently focuses on patients with advanced urothelial cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer who have exhausted standard treatment options.

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