Clinical-stage therapeutic discovery and development company Compugen Ltd. (Nasdaq:CGEN) (TASE:CGEN) announced on Monday the FDA clearance of the IND application for COM503.

This high-affinity anti-IL-18 binding protein antibody, licensed to Gilead Sciences, Inc., will initiate a Phase 1 trial in Q4 2024. The IND clearance has triggered a USD30m milestone payment from Gilead.

The Phase 1 trial will evaluate the safety and tolerability of COM503 as a monotherapy and in combination with Gilead's zimberelimab in participants with advanced or metastatic solid tumors globally.

Dr Cohen-Dayag highlighted the significance of COM503, emphasizing its potential in cancer therapeutics and its discovery through Compugen's computational technology.

This milestone enhances Compugen's financial position, providing a cash runway into 2027. Preparations for the Phase 1 trial are well-advanced.