The US Food and Drug Administration (FDA) has granted Compugen the green light to initiate a Phase I trial for COM503, a promising drug candidate designed to combat solid tumours. This approval not only marks a significant milestone in the development of COM503 but also activates a $30m milestone payment to Compugen from Gilead Sciences, underlining the partnership's strength and the potential of COM503.
COM503 is an anti-IL-18 binding protein antibody that has been exclusively licensed to Gilead Sciences for development and commercialization. The upcoming Phase I trial, anticipated to commence in the fourth quarter of this year, will be a first-in-human, dose escalation and dose expansion study. Its primary objectives are to evaluate the safety and tolerability of COM503, both as a standalone therapy and in combination with Gilead’s anti-PD-1 therapy, zimberelimab, targeting patients with advanced or metastatic solid tumours.
This development follows a licensing agreement signed last year between Compugen and Gilead, granting Gilead exclusive rights to develop and commercialize anti-IL-18 binding protein antibodies, including COM503. According to the agreement, Compugen is tasked with the preclinical development and the forthcoming Phase I trial, while Gilead retains exclusive rights to further develop and commercialize COM503 post-trial.
In addition to the $60m upfront payment Gilead has already provided to Compugen, the IND clearance triggers an additional $30m payment. Compugen is also poised to receive up to $758m in future payments, contingent upon achieving certain development, regulatory, and commercial milestones, potentially elevating the deal's total value to $848m. Moreover, Compugen is entitled to tiered royalties on worldwide net sales.
Anat Cohen-Dayag, Compugen's president and CEO, expressed enthusiasm about the FDA's IND clearance, stating, "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."