IO Biotech, a clinical-stage biopharmaceutical company focused on developing immune-modulating cancer vaccines, has achieved a significant milestone in its global Phase 3 clinical trial for IO102-IO103. The company has randomized 225 patients with advanced melanoma in combination with pembrolizumab. The trial protocol calls for an interim analysis of overall response rate one year after the enrollment of 225 patients. If the data obtained from this interim analysis are positive, it could allow for submission of a Biologics License Application for accelerated approval in the United States. IO102-IO103 is designed to target immunosuppressive mechanisms mediated by key immunosuppressive proteins IDO and PD-L1.
The IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic melanoma. With centers spread across the United States, Europe, Australia, Israel and South Africa; the targeted enrollment is 380 patients. The