Biohaven provides oncology program update

Biohaven (BHVN) provided an update and preliminary clinical data from its oncology development programs. Biohaven’s novel next-generation trophoblast cell surface antigen 2, Trop2, directed antibody drug conjugate or ADC, BHV-1510, demonstrated “encouraging” preliminary clinical activity both as a monotherapy and in combination with Regeneron’s (REGN) anti-PD-1 antibody cemiplimab. Early clinical data is consistent with BHV-1510’s preclinical profile showing high ADC stability, differentiated safety and efficacy, immunogenic cell death, and anti-PD-1 synergism. Monotherapy tumor reductions including partial responses have been seen in patients failing standard of care therapies. The combination of BHV-1510 and cemiplimab in the ongoing Phase 1 study shows encouraging anti-tumor activity, with tumor shrinkage in the first 6 out of 6 patients treated, including confirmed partial responses and in patients with brain metastasis. The majority of patients treated with the combination had failed prior anti-PD-1/PD-L1 therapies. BHV-1510 showed a favorable pharmacokinetic profile. As monotherapy, the main toxicity observed in the Phase 1 study has been stomatitis, an expected on-target Trop2 class toxicity that has been manageable. The combination with cemiplimab was well tolerated with no dose limiting toxicity to date in initial cohorts. Biohaven has also dosed the first patient in the Phase 1 study of BHV-1530, a potential first-in-class fibroblast growth factor receptor 3-directed ADC which utilizes the proprietary Topolx payload. Biohaven is also advancing a portfolio of technologies to modernize next-generation ADCs through strategic collaborations with Merus (MRUS) and GeneQuantum.