On December 12, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a Phase 1/2 clinical trial to evaluate IDE161, a small molecule inhibitor of poly (ADP-ribose) glycohydrolase (PARG), for the treatment of patients having solid tumors with homologous recombination deficiency (HRD) (Press release, Ideaya Biosciences, DEC 12, 2022, View Source [SID1234625153]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"IDE161 has an attractive preclinical profile, including single-agent tumor regressions in PARP inhibitor-resistant BRCA1/2 xenograft models, and a favorable preliminary preclinical myelosuppression safety profile relative to certain approved PARP inhibitors. 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," said Michael White, Ph.D., Senior Vice President and Chief Scientific Officer, IDEAYA Biosciences.
"There remains a significant unmet medical need for patients having tumors with homologous recombination deficiencies, such as BRCA1/2, and IDE161 has a potential opportunity for clinical differentiation in patients who are non-responsive to PARP inhibitors or to platinum-based treatments," said Dr. Darrin M. Beaupre, M.D., Ph.D., Senior Vice President and Chief Medical Officer, IDEAYA Biosciences.
IDE161 is a potent, selective, potential first-in-class small-molecule inhibitor of PARG, a novel and differentiated target in the same clinically validated pathway as poly (ADP-ribose) polymerase (PARP). Subject to effectiveness of the IND following FDA review, IDEAYA plans to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and preliminary efficacy of IDE161 as monotherapy in BRCA1/2-mutant breast and ovarian cancer patients.
IDEAYA owns or controls all commercial rights in IDE161, subject to certain economic obligations pursuant to its exclusive, worldwide license with Cancer Research UK and University of Manchester.
Additional information on IDE161, including scientific insights and clinical development opportunities, will be highlighted in an Investor R&D Day webcast being hosted by IDEAYA this morning, December 12, 2022, at 8:00 am – 9:30 am ET. Registration is available at View Source or View Source