Policy & Regulation
IDEAYA Biosciences selects potential first-in-class Pol Theta Helicase development candidate
29 June 2022 -

IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a US-based synthetic lethality focused precision medicine oncology company, announced on Tuesday that it has chosen a potential first-in-class Pol Theta Helicase development candidate (DC).

The product is a potential first-in-class small molecule inhibitor of the helicase domain of DNA Polymerase Theta.

The company is collaborating with UK-based pharmaceutical company GSK on IND-enabling studies to support the assessment of the Pol Theta Helicase DC in combination with niraparib, GSK's PARP inhibitor, for patients having tumours 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 preclinical and IND-enabling studies, to enable first-in-human studies in the first half of 2023.

IDEAYA and GSK are collaborating on the ongoing IND-enabling studies, and GSK will lead clinical development for the Pol Theta program. GSK holds a global, exclusive license to develop and commercialise the Pol Theta Helicase DC and is responsible for all research and development costs for the program, including those incurred by IDEAYA. IDEAYA is eligible to receive future development and regulatory milestones of up to USD485m aggregate, inclusive of preclinical and clinical milestones of up to USD10m aggregate for advancing this asset through IND effectiveness.

Upon potential commercialisation, IDEAYA will be eligible to receive up to USD475m 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.