IDEAYA Biosciences Says FDA Clears IND For Pol Theta Helicase Development Candidate GSK101


Oncology company IDEAYA Biosciences, Inc. (IDYA) announced Monday the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a GSK-sponsored Phase 1/2 clinical trial to evaluate GSK101 (IDE705) for the treatment of patients having tumors with BRCA or other homologous recombination (HR) mutations or homologous recombination deficiency (HRD).

GSK101 (IDE705) is a small molecule inhibitor of Pol Theta Helicase, in combination with niraparib, the GSK small molecule inhibitor of poly-(ADP-ribose) polymerase (PARP). It is a potential first-in-class small molecule inhibitor of the helicase domain of DNA Polymerase Theta (Pol Theta).

GSK101 was discovered and preclinically evaluated by IDEAYA in collaboration with GSK, which is responsible for all research and development costs for the program.

In preclinical studies, the GSK101 and niraparib combination resulted in deeper and more durable regressions or efficacious responses relative to either single agent in BRCA mutant models.

IDEAYA is eligible to receive a $7 million milestone payment upon acceptance of the IND by the U.S. Food and Drug Administration (FDA), and a potential additional $10 million milestone payment upon initiation of Phase 1 clinical dose expansion.

IDEAYA may potentially also receive further aggregate later-stage development and regulatory milestones of up to $465 million.

Upon potential commercialization, IDEAYA will be eligible to receive up to $475 million of commercial milestones and tiered royalties on global net sales by GSK, its affiliates and their sublicensees ranging from high single digit to sub-teen double-digit percentages, subject to certain customary reductions.

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