IDEAYA's IDE161 IND Gets FDA Clearance To Proceed To Phase 1 Clinical Trial In Solid Tumors

IDEAYA Biosciences, Inc. (IDYA), a precision medicine oncology company, announced Monday that the U.S. Food and Drug Administration has completed its safety review of the Investigational New Drug or IND application of first-in-class PARG Development Candidate IDE161.

The agency has concluded that IDEAYA's proposed clinical study may proceed to evaluate IDE161 as a potential first-in-class treatment for patients having tumors with homologous recombination deficiencies or HRD, such as breast and ovarian cancer patients with BRCA1 or BRCA2 mutations.

IDE161 is a potent, selective, small-molecule inhibitor of PARG, a novel and differentiated target in the same clinically validated pathway as poly (ADP-ribose) polymerase (PARP).

IDEAYA said it plans to initiate dosing in a Phase 1 clinical trial in the first quarter to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and preliminary efficacy of IDE161 as monotherapy in the HRD and BRCA1/2 biomarker settings in multiple solid tumors, with a strategic focus in breast cancer.

Darrin Beaupre, Senior Vice President and Chief Medical Officer, IDEAYA, said, "Preclinical toxicology data supports a Phase 1 starting dose that is one-half of the estimated human efficacious dose, which we believe may enable a therapeutic dose in earlier cohorts of the dose escalation."

IDEAYA owns all commercial rights in IDE161, subject to certain economic obligations under its exclusive, worldwide license with Cancer Research UK and University of Manchester.

The company said it would highlight IDE161 preclinical profile and clinical development plans at J.P. Morgan Healthcare Conference on January 10.

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