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IDEAYA Biosciences Secures IND Clearance for IDE275 (GSK959) to Initiate Phase 1 Trial in MSI-High Solid Tumors

NextEdge Admin

29 Oct 2024

2 min 34 sec

IDEAYA Biosciences, a precision oncology company focused on targeted therapeutics, announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for IDE275 (GSK959). This clearance allows the initiation of a Phase 1 clinical trial to evaluate IDE275, a first-in-class and best-in-class Werner Helicase (WRN) inhibitor, in patients with high microsatellite instability (MSI-High) tumors. Preclinical studies have shown IDE275’s strong and selective synthetic lethality in MSI-High biomarker models, with promising monotherapy tumor regressions.

The upcoming Phase 1 trial will focus on MSI-High solid tumors, which occur in approximately 31% of endometrial, 20% of colorectal, and 19% of gastric cancers. GSK is leading the IND application and clinical development efforts, with plans to test IDE275 both as a monotherapy and in combination with a PD-1 inhibitor. The trial is expected to begin in Q4 2024.

Yujiro S. Hata, President and CEO of IDEAYA, emphasized the potential impact of IDE275, calling it the company’s fifth first-in-class clinical program with a potentially best-in-class profile. IDE275 was discovered through a collaboration between IDEAYA and GSK, which shares development costs—80% covered by GSK and 20% by IDEAYA.

IDEAYA will receive a $7 million milestone payment for FDA clearance of the IND and an additional $10 million upon Phase 1 dose expansion. The company may earn up to $465 million in later-stage development and regulatory milestones, plus $475 million in commercial milestones. Upon commercialization, IDEAYA will receive 50% of U.S. net profits and tiered royalties on non-U.S. global sales ranging from high single-digit to low double-digit percentages.