FDA Clears COM503 IND in Solid Tumors, Phase 1 Trial Anticipated

Tumor cell: © nevio - stock.adobe.com

• The FDA has cleared the investigational new drug (IND) application to begin a phase1 study for COM503.
• COM503 Is a potential first-in-class treatment for solid tumors.
• The phase 1 trial is on track to begin in Q4 2024.

The IND application of COM503 has been cleared by the FDA, and a phase 1 trial investigating the agent in solid tumors is planned to commence in Q4 2024.¹

"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, PhD, president and chief executive officer of Compugen, in a press release. "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."

COM503 is a potential first-in class, high affinity anti-IL-18 binding protein. The phase 1 study will assess the safetyand tolerability of COM503 alone and in combination with zimberelimab, an anti-PD-1 monoclonal antibody, in patients with advanced or metastatic solid tumors.

Compugen has several other immuno-oncologic agents in its pipeline.² These include the anti-PD-1/TIGIT bispecific antibody rilvegostomig (AZD2936), COM701, and COM902. COM7, an anti-PVRIG antibody, and COM902, an anti-TIGIT antibody, are being investigated in combination with pembrolizumab (Keytruda) for the treatment of metastatic microsatellite stable colorectal cancer and platinum-resistant ovarian cancer.

REFERENCES:

1. Compugen announces FDA clearance of IND for COM503 for the treatment of solid tumors. News release. Compugen Ltd. July 29, 2024. Accessed July 30, 2024. https://tinyurl.com/4s3ap27e

2. Pipeline. Compugen Ltd. Accessed July 30, 2024. https://cgen.com/pipeline/