Compugen Announces FDA Clearance of IND for COM503 for the Treatment of Solid Tumors

Core Insights - The FDA has granted clearance for Compugen's investigational new drug application for COM503, leading to a $30 million milestone payment from Gilead [1][2] - Compugen plans to initiate a Phase 1 trial for COM503 in advanced solid tumors in Q4 2024 [1][2] Company Overview - Compugen Ltd. is a clinical-stage cancer immunotherapy company specializing in computational target discovery [5] - The company has two proprietary product candidates in Phase 1 development: COM701 and COM902, alongside COM503 [5] COM503 Details - COM503 is a high affinity anti-IL-18 binding protein antibody, which is being developed as a monotherapy and in combination with Gilead's anti-PD-1 antibody, zimberelimab [3][4] - The Phase 1 trial will assess the safety and tolerability of COM503 in participants with advanced or metastatic solid tumors globally [3] Partnership with Gilead - In 2023, Compugen and Gilead entered a license agreement granting Gilead exclusive rights to develop and commercialize anti-IL-18 binding protein antibodies, including COM503 [4] - Gilead provided an upfront payment of $60 million and will make additional milestone payments, with a total deal value of up to $848 million [4]