Business
IDEAYA Announces Phase 1 Expansion and Preliminary Clinical Proof-of-Concept for Potential First-in-Class PARG Inhibitor IDE161 in HRD Solid Tumors
Initiated IDE161 Phase 1 expansion based on preliminary tumor shrinkage observed in multiple HRD solid tumor patients, including an endometrial cancer subject
About this update from Ideaya Biosciences, Inc.
[{"type":"text","content":"Initiated IDE161 Phase 1 expansion based on preliminary tumor shrinkage observed in multiple HRD solid tumor patients, including an endometrial cancer subject with a first imaging assessment of a partial response and an 87% reduction of the CA-125 tumor markerPhase 1 expansion focus in ER+, Her2(-), HRD+ breast cancer representing ~10% to ~14% of breast cancer as well as HRD+ ovarian cancer and other HRD-associated solid tumorsDemonstrated IDE161 target engagement based on pharmacodynamic modulation of PAR, and achieved human exposures correlating to tumor regressions in preclinical modelsIDE161 Phase 1 dose optimization ongoing to confirm move forward Phase 2 expansion doseTargeting IDE161 clinical program updates in H2 2023SOUTH SAN FRANCISCO, Calif., Sept. 11, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announces initiation of a Phase 1 monotherapy expansion in the first-in-human clinical trial evaluating IDE161 (NCT 05787587). \n\n \n \n \n \n \n \n\n \n\"We are pleased to advance IDE161, a potential first-in-class PARG inhibitor, into an expansion phase of our Phase 1 clinical trial and are excited to explore its potential in cancer patients with homologous recombination deficiency (HRD). Based on extensive preclinical studies, we are focusing this expansion in several priority tumor types, including ER+, Her2(-) breast cancer and ovarian cancer subjects with tumors that harbor HRD,\" said Dr. Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.\n\"The clinical update today on IDE161 represents the first reported preliminary clinical proof-of-concept for a PARG inhibitor in HRD solid tumors. We look forward to the continued evaluation of IDE161 as a monotherapy in high unmet medical need HRD solid tumor indications,\" said Yujiro S. Hata, Chief Executive Officer, IDEAYA Biosciences.\nThe Phase 1 first-in-human clinical trial is evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic properties and preliminary efficacy of IDE161 in patients having tumors with homologous recombination deficiency (HRD). Early clinical data from the dose escalation cohorts showed dose-dependent pharmacodynamic modulation of poly-ADP ribose (PAR) proteins in peripheral blood, demonstr...