The US Food and Drug Administration (FDA) has approved an investigational new drug (IND) application from Compugen to begin a Phase I trial of COM503, a drug candidate designed to treat solid tumours.
COM503 is an anti-IL-18 binding protein antibody currently licensed to Gilead Sciences.
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The FDA’s IND clearance triggered a $30m milestone payment to Compugen from Gilead.
Compugen is preparing to begin the Phase I trial in the fourth quarter of this year.
The first-in-human, dose escalation and dose expansion study will aim to evaluate COM503’s safety and tolerability both as a standalone therapy and in combination with Gilead’s anti-PD-1 therapy, zimberelimab, for patients with advanced or metastatic solid tumours.
Last year, Compugen signed a licensing agreement giving Gilead exclusive rights for developing and commercialising anti-IL-18 binding protein antibodies, including COM503.
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By GlobalDataUnder this agreement, Compugen is responsible for the preclinical development and the anticipated Phase I trial, while Gilead will have exclusive rights to further develop and commercialise COM503 after the trial.
Gilead has already provided Compugen with a $60m upfront payment and, following the IND clearance, will make an additional $30m payment.
Compugen stands to receive up to an additional $758m in future payments based on development, regulatory and commercial milestones, potentially bringing the deal’s total value to $848m.
In addition, the company will receive tiered royalties on worldwide net sales.
Compugen president and CEO Anat Cohen-Dayag said: “We are thrilled to receive FDA IND clearance for COM503, which triggers a $30m milestone payment from our partner Gilead, and the initiation of a Phase I trial will keep us on track to expedite COM503 development.
“This achievement reflects our track record in execution and diversity in our pipeline, adding another clinical programme discovered through our predictive computational discovery engine.
Last month, Compugen dosed the first subject in a proof-of-concept trial of COM701, COM902 and pembrolizumab for ovarian cancer.
