NEW YORK – Ideaya Biosciences on Monday said it is advancing the investigational agent Pol Theta Helicase development candidate (DC) toward the clinic, thereby achieving a preclinical development milestone in its ongoing collaboration with GlaxoSmithKline.
The firm is collaborating with GSK on preclinical and investigational new drug (IND) application-enabling studies involving the first-in-class small molecule inhibitor of the helicase domain of DNA Polymerase Theta. The two firms are evaluating the investigational agent in combination with GSK's PARP inhibitor Zejula (niraparib) in preclinical studies. They expect to submit an IND to the US Food and Drug Administration for Pol Theta Helicase DC in the first half of 2023 and begin a first-in-human trial in patients with tumors harboring mutations in BRCA1/2 or homologous recombination repair deficiency.
In June, Ideaya selected Pol Theta Helicase DC as its lead candidate in this program. Once the IND is submitted and cleared, GSK will take over clinical development of the drug, as stipulated in its 2020 collaboration agreement with Ideaya. In the deal, Ideaya is eligible to receive up to $485 million in development and regulatory milestone payments and up to $475 million in commercial milestones as well as tiered royalties on sales of the drug.
Under the original agreement, GSK also had rights to option Ideaya's two other synthetic lethality programs: the MAT2A and Werner syndrome helicase programs. Earlier this month, GSK waived rights to the MAT2A candidate, IDE397, but Ideaya will continue to develop the drug on its own in solid tumors harboring an MTAP deletion.