clinical trial

Bicara Therapeutics presented positive Phase 1/1b trial data for ficerafusp alfa, a bifunctional antibody, combined with pembrolizumab in first-line recurrent/metastatic head and neck cancer. The results, particularly in HPV-negative patients, showed significant antitumor activity, including a median duration of response of 21.7 months, median overall survival of 21.3 months, and a two-year overall survival rate of 46%. The data supports the advancement of the FORTIFI-HN01 pivotal trial.

Innovent Biologics announced positive Phase 1/2 data for IBI363, a PD-1/IL-2α-bias bispecific antibody, at ASCO 2025. The study showed promising results in immunotherapy-resistant acral and mucosal melanoma (“cold tumors”), demonstrating a 23.3% confirmed objective response rate and 14.8 months median overall survival. A Phase 2 registration trial for IBI363 is underway, offering a potential breakthrough for advanced melanoma treatment.

Biohaven launched a global Phase 2/3 trial for BHV-8000, a first-in-clinic, brain-penetrant TYK2/JAK1 inhibitor, targeting neuroinflammation in Parkinson’s disease. The drug aims to address the underlying cause of disease progression, with no existing disease-modifying therapies currently available. The trial will enroll 550 patients across 13 countries to assess efficacy and safety, utilizing innovative endpoints. BHV-8000 has shown safety and tolerability, with robust brain penetration, representing a potential breakthrough in treating neurodegenerative diseases.