IDEAYA Biosciences, Inc. announced on October 28, 2024, that the U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application for IDE275 (GSK959). This clearance allows for the initiation of a Phase 1 clinical trial to evaluate the Werner Helicase (WRN) inhibitor.
IDE275 (GSK959) is a potential first-in-class and best-in-class WRN inhibitor that has demonstrated robust and selective synthetic lethality in preclinical studies in the high microsatellite instability (MSI-High) biomarker setting. The Phase 1 clinical trial will enroll patients with MSI-High tumors.
IDEAYA earned a $7 million milestone payment from GSK upon IND acceptance. GSK is the sponsor of the IND application and will be responsible for 80% of global research and development costs for IDE275 (GSK959), with IDEAYA responsible for the remaining 20%.
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