IDEAYA Biosciences has announced that the U.S. Food and Drug Administration (FDA) has granted fast-track designation to its development program focused on IDE161. This program aims to investigate IDE161 as a potential treatment for adult patients with advanced or metastatic hormone receptor positive, Her2- breast cancer who have germline or somatic BRCA 1/2 mutations.
IDE161 is a powerful and selective inhibitor of poly glycohydrolase, specifically targeting BRCA1/2-mutant breast and ovarian cancers.
Fast track is an FDA process that expedites the review and development of drugs to address serious conditions and meet unmet medical needs.
Currently, IDEAYA is conducting a Phase 1 first-in-human clinical trial to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties, as well as the preliminary efficacy of IDE161 in patients with solid tumors displaying homologous recombination deficiency.
IDEAYA plans to provide program updates for IDE161 in the fourth quarter of 2023. The company holds all commercial rights in IDE161, with certain economic obligations under its exclusive, worldwide license with Cancer Research UK and University of Manchester.