On August 29, 2022 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that it has achieved a preclinical development milestone in connection with ongoing IND-enabling studies for its Pol Theta Helicase Development Candidate (DC) (Press release, Ideaya Biosciences, AUG 29, 2022, View Source [SID1234618747]).
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"We are excited to advance our Pol Theta Helicase Inhibitor DC toward the clinic. The achievement of this preclinical milestone supplements our balance sheet and reflects the continued progress IDEAYA and GSK are making to enable first-in-human studies with this development candidate in the first half of next year," said Michael White, Senior Vice President and Chief Scientific Officer of IDEAYA Biosciences.
The Pol Theta Helicase Inhibitor DC is a potential first-in-class small molecule inhibitor of the helicase domain of DNA Polymerase Theta. IDEAYA is collaborating with GSK on IND-enabling studies to support the evaluation of the Pol Theta Helicase DC in combination with niraparib, GSK’s PARP inhibitor, for patients harboring tumors with BRCA or other homologous recombination (HR) mutations or homologous recombination deficiency (HRD).
IDEAYA and GSK are targeting an IND submission for the Pol Theta Helicase DC, subject to satisfactory completion of ongoing IND-enabling studies, to enable first-in-human studies in the first half of 2023.
GSK will lead clinical development for the Pol Theta program pursuant to its global, exclusive license to develop and commercialize the Pol Theta Helicase Inhibitor DC. GSK is responsible for all research and development costs for the program. IDEAYA is eligible to receive total development and regulatory milestones of up to $485 million aggregate, inclusive of preclinical and clinical milestones of up to $20 million aggregate for advancing the Pol Theta Helicase DC through early Phase 1 clinical.
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.