NEW YORK – Ideaya Biosciences on Monday said it has submitted an investigational new drug application to the US Food and Drug Administration, seeking permission to start a Phase I/II trial of an investigational PARG inhibitor, IDE161, in solid tumors with BRCA1/2 mutation-driven homologous recombination deficiency.
South San Francisco, California-based Ideaya wants to move the drug into human studies based on preclinical experiments showing that IDE161 had single-agent anti-tumor activity in PARP inhibitor-resistant BRCA1/2-deficient xenograft models and a favorable safety profile compared to other PARP inhibitors with regard to myelosuppression.
"The IND submission for IDE161 is a significant milestone for Ideaya and reflects our unique platform capabilities in synthetic lethality for target and biomarker identification, and drug discovery," Michael White, CSO and senior VP at Ideaya, said in a statement.
IDE161 is designed to inhibit PARG, another target in the same pathway as PARP. If the FDA approves Ideaya's IND, the company will begin studying the drug's safety, tolerability, pharmacokinetic and pharmacodynamic properties, and preliminary efficacy in breast and ovarian cancer patients with BRCA1/2 mutations.
Ideaya owns or controls commercial rights to IDE161 but said it has certain economic obligations under an exclusive, worldwide license agreement with Cancer Research UK and the University of Manchester.