clinical trial
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ASCO 2025: Innovent Presents Phase 1/2 Data for IBI363, a First-in-Class PD-1/IL-2α Bispecific Antibody, in Immunotherapy-Refractory Advanced Melanoma
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.
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Biohaven Initiates Phase 2/3 Trial for Early Parkinson’s Disease, Testing Brain-Penetrant TYK2/JAK1 Inhibitor Against Neuroinflammation
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.
