COM-503
- Generic Name
- COM-503
Compugen Announces Key Leadership Transition: CEO Cohen-Dayag to Become Executive Chair as CSO Ophir Takes Helm
• Compugen Ltd. has announced significant leadership changes effective September 2025, with current CEO Anat Cohen-Dayag transitioning to Executive Chair and CSO Eran Ophir being appointed as the new President and CEO.
• Under Cohen-Dayag's 15-year leadership, Compugen transformed into a clinical-stage cancer immunotherapy company with a pipeline built on its proprietary AI/ML-driven Unigen™ computational discovery platform.
• The company maintains a strong position with multiple clinical-stage assets, including partnerships with AstraZeneca and Gilead, and reports a cash runway extending into 2027.
Cogent Bio Presents Bezuclastinib Data Highlighting Long-Term Benefits in Non-Advanced Systemic Mastocytosis
• Cogent Biosciences will present a poster on bezuclastinib at the AAAAI Annual Meeting, focusing on long-term symptomatic benefits in NonAdvSM patients.
• The poster highlights efficacy and safety results from the ongoing SUMMIT trial in adult NonAdvSM patients receiving 100mg of bezuclastinib.
• Cogent anticipates top-line results from the SUMMIT trial in July 2025 and plans to submit an NDA for bezuclastinib by the end of 2025.
• Expanded Access Programs for bezuclastinib are expected to launch in the U.S. in Q1 2025 for Systemic Mastocytosis and Gastrointestinal Stromal Tumors patients.
Compugen's COM503, an Anti-IL-18 Binding Protein Antibody, Enters Phase 1 Trial for Advanced Solid Tumors
• Compugen's COM503, a potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead, has entered Phase 1 clinical trials.
• The Phase 1 trial will assess the safety, tolerability, and pharmacokinetics of COM503 as a monotherapy and in combination with zimberelimab in advanced solid tumors.
• COM503 aims to enhance anti-tumor immune responses by blocking the IL-18 binding protein, releasing naturally occurring IL-18 within tumors.
• Compugen is responsible for the Phase 1 trial, with Gilead holding exclusive rights for further development and commercialization of COM503.
FDA's July Roundup: Approvals, Fast Tracks, and Designations in Oncology
• The FDA approved FoundationOne Liquid CDx as a companion diagnostic for niraparib and abiraterone in BRCA-mutated metastatic castration-resistant prostate cancer.
• Several therapies received fast track designations, including OBX-115 for advanced melanoma and ADI-270 for metastatic clear cell renal cell carcinoma.
• Biologics license applications were accepted for remestemcel-L in pediatric steroid-refractory acute graft-vs-host disease and tabelecleucel for Epstein-Barr virus-positive posttransplant lymphoproliferative disease.
• The Oncologic Drugs Advisory Committee voted to require comprehensive phase assessments for new trial designs in perioperative regimens for non-small cell lung cancer.
Drug Development Updates
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