Compugen Secures FDA Approval for IND Application of COM503 in Solid Tumor Treatment

Compugen Secures FDA Approval for IND Application of COM503 in Solid Tumor Treatment

By, Admin 31 July 2024

Overview

Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a leader in computational target discovery, has announced that the U.S. Food and Drug Administration (FDA) has approved their investigational new drug (IND) application for COM503. This approval will 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). This milestone has triggered a $30 million payment from Gilead. The Phase 1 trial is set to begin in solid tumors in the fourth quarter of 2024.

Words from CEO: Compugen

  • We are thrilled to receive FDA IND clearance for COM503, which triggers a $30 million milestone payment from our partner Gilead. The initiation of a Phase 1 trial will keep us on track to expedite COM503 development,"" said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. 
  • We are excited about the potential of COM503, a differentiated antibody approach to harness cytokine biology for cancer therapeutics, discovered through our computational work at Compugen.
  • Dr. Cohen-Dayag continued, ""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.""

The Phase 1 trial will be a first-in-human, dose escalation and dose expansion study. It will assess the safety and tolerability of COM503 as both a monotherapy and in combination with Gilead's anti-PD-1, zimberelimab, in participants with advanced or metastatic solid tumors globally.

License Agreement Between Compugen & Gilead

  • In 2023, Compugen and Gilead entered into a license agreement, granting Gilead exclusive rights to develop and commercialize anti-IL-18 binding protein antibodies, including COM503. 
  • Compugen is responsible for preclinical development and the initial Phase 1 trial to evaluate the safety and tolerability of COM503. 
  • Gilead will take over development and commercialization after Phase 1. 
  • The agreement included a $60 million upfront payment from Gilead and a $30 million payment upon IND clearance. 
  • Compugen is eligible to receive up to an additional $758 million in future development, regulatory, and commercial milestone payments, with a total potential deal value of up to $848 million. 
  • Compugen will also receive single-digit to low double-digit tiered royalties on worldwide net sales.

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