Innovent Biologics Inc. has announced updated data from its Phase 1 and Phase 2 clinical studies on IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. This study focuses on patients with advanced malignant melanoma, particularly the acral and mucosal subtypes, which are typically resistant to treatment. The research has shown promising results in these hard-to-treat "cold" tumors. Innovent Biologics is also conducting a pivotal Phase 2 registrational trial comparing IBI363 monotherapy to pembrolizumab in patients with unresectable, locally advanced, or metastatic mucosal and acral melanoma. The trial aims to enroll 180 patients and will evaluate progression-free survival as the primary endpoint. IBI363 was generally well tolerated, with manageable safety profiles, and no new safety risks were identified.