Compugen Gets FDA IND Approval for COM503 to Treat Solid Tumors

Compugen Ltd., a clinical-stage company focused on cancer immunotherapy and noted for its work in computational target discovery, has announced that its investigational new drug (IND) application for COM503 has received clearance from the U.S. Food and Drug Administration (FDA). This clearance allows the company to proceed with a Phase 1 clinical trial of COM503, which is a high-affinity anti-IL-18 binding protein antibody. This development has also triggered a $30 million milestone payment from Gilead Sciences, Inc., which has licensed COM503.

COM503 represents a pioneering approach in cancer therapeutics by leveraging cytokine biology. The Phase 1 trial, set to begin in the fourth quarter of 2024, will focus on participants with advanced or metastatic solid tumors. The study will evaluate the safety and tolerability of COM503 both as a standalone treatment and in combination with zimberelimab, Gilead's anti-PD-1 antibody.

Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, expressed excitement about the FDA clearance and the potential of COM503. She highlighted that this milestone reflects the company's capability in executing its plans and diversifying its clinical pipeline through its predictive computational discovery engine. The approval is expected to strengthen Compugen's financial position, giving it a cash runway extending into 2027.

The Phase 1 trial will be the first in-human study of COM503, involving dose escalation and dose expansion to assess the drug's safety and tolerability. The trial will be conducted globally and will focus on patients with advanced or metastatic solid tumors.

The license agreement between Compugen and Gilead, established in 2023, grants Gilead exclusive rights to develop and commercialize anti-IL-18 binding protein antibodies, including COM503. Compugen retains responsibility for the preclinical development and the initial human trials of COM503. Following these stages, Gilead will assume full responsibility for further development and commercialization. The agreement included a $60 million upfront payment from Gilead to Compugen, and the recent FDA clearance of COM503 has triggered an additional $30 million payment. Compugen stands to receive up to $848 million in total, contingent on future developmental, regulatory, and commercial milestones, plus tiered royalties on global net sales.

Compugen’s broader research efforts in cancer immunotherapy include other advanced projects such as COM701, an anti-PVRIG antibody, and COM902, an antibody targeting TIGIT. Both are in Phase 1 development. Additionally, AstraZeneca is advancing a bispecific antibody derived from COM902 into Phase 3 trials through a licensing agreement with Compugen.

Headquartered in Holon, Israel, with offices in San Francisco, Compugen employs its computational discovery capabilities to identify novel drug targets and biological pathways. The company’s shares trade on both Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN.

Compugen’s innovative approach and strategic partnerships continue to strengthen its position in the field of cancer immunotherapy, offering new hope for treatments targeting various mechanisms of immune resistance. The pending Phase 1 trial of COM503 is a significant step in their mission to develop effective cancer therapies.