Press release
Compugen Announces FDA Clearance of IND for COM503 for the Treatment of Solid Tumors
FDA clearance triggers a $30 million milestone payment from GileadCompany on track to initiate a Phase 1 trial for COM503, a differentiated antibody approach
About this update from Compugen Ltd.
[{"type":"text","content":"FDA clearance triggers a $30 million milestone payment from GileadCompany on track to initiate a Phase 1 trial for COM503, a differentiated antibody approach to harness cytokine biology for cancer therapeutics as monotherapy and in combination in advanced solid tumors in Q4 2024HOLON, Israel, July 29, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to initiate a Phase 1 trial for COM503, a potential first-in-class, high affinity anti-IL-18 binding protein antibody licensed to Gilead Sciences, Inc. (Gilead). The IND clearance triggered a $30 million milestone payment from Gilead and Compugen is on track to initiate the Phase 1 trial in solid tumors, in the fourth quarter of 2024.\n\n\"We are thrilled to receive FDA IND clearance for COM503 which triggers a $30 million milestone payment from our partner Gilead, and the initiation of a Phase 1 trial will keep us on track to expedite COM503 development,\" said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. \"We are excited about the potential of COM503, a differentiated antibody approach to harness cytokine biology for cancer therapeutics which we discovered through our computational discovery work at Compugen.\"\nDr. Cohen-Dayag added, \"This achievement reflects our track record in execution and diversity in our pipeline, adding another clinical program discovered through our predictive computational discovery engine. In addition, it further strengthens our balance sheet with an expected cash runway sufficient to take us into 2027. We look forward to the initiation of the Phase 1 trial in the fourth quarter of this year, for which our preparation is well-advanced.\"\nAbout COM503 Phase 1 trialThe Phase 1 trial is a first-in-human, dose escalation and dose expansion trial to assess the safety and tolerability of COM503 as a monotherapy and in combination with Gilead's anti-PD-1, zimberelimab in participants with advanced or metastatic solid tumors globally.\nAbout the Compugen-Gilead license agreementIn 2023, Compugen and Gilead entered into a license agreement, pursuant to which Gilead was granted exclusive rights to dev...