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IDEAYA Reports Preclinical Development Milestone In Ongoing IND-enabling Studies With GSK

IDEAYA Biosciences, Inc. (IDYA), a synthetic lethality focused precision medicine oncology company, announced Monday that it has achieved a preclinical development milestone in connection with ongoing IND-enabling studies for its Pol Theta Helicase Development Candidate or DC.

The Pol Theta Helicase Inhibitor DC is a potential first-in-class small molecule inhibitor of the helicase domain of DNA Polymerase Theta.

For the program, the company is collaborating with GSK to support evaluation of Pol Theta Helicase Inhibitor DC in combination with niraparib, GSK's PARP inhibitor. It is for patients harboring tumors with BRCA or other homologous recombination or HR mutations or homologous recombination deficiency or 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 said it 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.

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