IDEAYA Biosciences Gets Fast-Track Designation for IDE161 for Breast Cancer

By Chris Wack

IDEAYA Biosciences said Wednesday that the U.S. Food and Drug Administration has granted fast-track designation to its development program investigating IDE161 for the treatment of adult patients having advanced or metastatic hormone receptor positive, Her2- breast cancer with germline or somatic BRCA 1/2 mutations.

IDE161 is the company's potent and selective inhibitor of poly glycohydrolase in both BRCA1/2-mutant breast and ovarian cancers.

Fast track is a U.S. FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

IDEAYA's Phase 1 first-in-human clinical trial is evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic properties and preliminary efficacy of IDE161 in patients having solid tumors with homologous recombination deficiency.

IDEAYA is targeting program updates for IDE161 in the fourth quarter of 2023. The company owns or controls all commercial rights in IDE161, subject to certain economic obligations under its exclusive, worldwide license with Cancer Research UK and University of Manchester.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

September 27, 2023 06:28 ET (10:28 GMT)

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