Thursday, September 28, 2023
IDEAYA Biosciences, a precision medicine oncology company listed on NASDAQ as IDYA, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for their developmental program involving IDE161. IDE161 is a highly selective inhibitor targeting poly (ADP-ribose) glycohydrolase (PARG) and is being explored as a potential treatment for advanced or metastatic hormone receptor-positive (HR+), Her2-negative breast cancer. This designation applies to adult patients who possess either germline or somatic BRCA1/2 mutations and have experienced disease progression after undergoing at least one line of hormonal therapy, CDK4/6 inhibitor therapy, and poly (ADP-ribose) polymerase (PARP) inhibitor therapy.
Dr. Darrin Beaupre, Chief Medical Officer at IDEAYA Biosciences, expressed, "The U.S. FDA Fast Track designations for our potential first-in-class PARG inhibitor, IDE161, in both BRCA1/2-mutant breast and ovarian cancers reflect the potential for IDE161 to address the significant unmet medical need in these indications." Dr. Beaupre also conveyed their anticipation of providing further updates regarding the IDE161 program in the fourth quarter of the current year.
Fast Track designation is a specialized program by the FDA intended to expedite the development and review of drugs targeting severe medical conditions with unmet needs. Under this designation, IDE161's development program for BRCA1/2 mutant breast cancer becomes eligible for several regulatory review processes, including enhanced FDA interactions, potential consideration for a rolling review of a New Drug Application (NDA), and the possibility of accelerated approval and priority review of an NDA.
IDEAYA is currently conducting a Phase 1 clinical trial to assess IDE161's safety, tolerability, pharmacokinetics, pharmacodynamics, and initial efficacy in patients with solid tumors exhibiting homologous recombination deficiency (HRD). Preliminary data from the trial indicated signs of tumor shrinkage in several patients with HRD+ solid tumors, including individuals with BRCA 1/2 mutant endometrial and colon cancers. The trial is set to expand to include HRD+ associated breast cancer, ovarian cancer, and a range of other selected solid tumors. HRD+ breast cancer accounts for approximately 10% to 14% of breast cancer cases, while HRD+ ovarian cancer represents about 50% of ovarian cancer cases.
IDEAYA expects to provide updates on the IDE161 program in the fourth quarter of 2023. It's worth noting that IDEAYA holds all commercial rights for IDE161, subject to specific economic obligations as per their exclusive worldwide license agreement with Cancer Research UK and the University of Manchester.