Biohaven Oral Presentation Highlights FGFR3 ADC Progress
News related to:Biohaven Ltd · 3 min read
NEW HAVEN, Conn., Sept. 28, 2026 /CourierPR/ -- The findings from the ongoing BHV1530-101 study will be featured in an oral presentation at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026), a leading international forum for early-phase oncology drug development. The symposium is scheduled to take place from November 18 to 20, 2026, at the CCIB in Barcelona, Spain. The oral presentation will provide an update from the ongoing BHV1530-101 study, which is a Phase 1, first-in-human, open-label, multicenter, dose-escalation, dose-expansion, and dose-confirmation study evaluating BHV-1530 as monotherapy and in combination with cemiplimab in adult participants with advanced or metastatic solid tumors.
BHV-1530 is a first-in-class potential FGFR3-directed antibody-drug conjugate incorporating Biohaven's proprietary TopoIx payload. The study has shown early clinical activity, including confirmed partial responses in heavily pretreated patients. The data have demonstrated a favorable and differentiated safety profile, with no dose-limiting toxicities and no FGFR inhibitor-class toxicities, such as hyperphosphatemia, nail disorders, stomatitis, or retinopathy, that commonly constrain dosing and duration of approved FGFR tyrosine kinase inhibitors.
The session is scheduled for 19 November 2026 at 10:00am.
Biohaven Ltd., a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, has entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate the combination of BHV-1530 and cemiplimab (Libtayo®) in patients with solid tumors. Enrollment into the combination cohort evaluating BHV-1530 with cemiplimab has begun. BHV-1530's TopoIx payload has been demonstrated to generate immunogenic cell death and stimulate an antitumor immune response, providing a compelling mechanistic rationale for combination with checkpoint inhibition. This agreement builds upon the existing clinical supply agreement between Biohaven and Regeneron for BHV-1510, a next-generation TROP2-directed ADC, further deepening the collaborative relationship between the two companies across Biohaven's oncology pipeline.
BHV-1530 is an antibody-drug conjugate directed against FGFR3, a validated but underexploited target in urothelial cancer and other FGFR3-driven cancers. It is a first-in-class potential FGFR3-directed ADC incorporating Biohaven's proprietary TopoIx payload. Unlike approved FGFR tyrosine kinase inhibitors, which are restricted to genomically selected patients and constrained by class-related toxicities, BHV-1530 is designed to target FGFR3 independent of requiring pathway inhibition, with the potential to address both FGFR3-altered and wild-type overexpressing tumors. Biohaven has initiated combination cohorts evaluating BHV-1530 with anti-PD-1 therapy, including the combination with cemiplimab (Libtayo), which is now enrolling.
Biohaven Ltd. (NYSE: BHVN) is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. The company is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; and myostatin inhibition for neuromuscular and metabolic diseases, including obesity.
Biohaven Ltd. (NYSE: BHVN) is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. The company is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; and myostatin inhibition for neuromuscular and metabolic diseases, including obesity.