IDEAYA Biosciences Pronounces Submission of IND Utility to the U.S. FDA for PARG Growth Candidate IDE161

IDEAYA Biosciences Pronounces Submission of IND Utility to the U.S. FDA for PARG Growth Candidate IDE161

–   IDE161 is being developed as a possible first-in-class PARG inhibitor for sufferers having tumors with HRD, with an preliminary focus in BRCA1/2-mutant Breast and Ovarian Most cancers

–   Proposed medical improvement plan for IDE161 to be highlighted in Investor R&D Day webcast being hosted by IDEAYA as we speak, December 12, 2022, at 8:00 am ET

SOUTH SAN FRANCISCO, Calif., Dec. 12, 2022 /PRNewswire/ — IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an artificial lethality centered precision drugs oncology firm dedicated to the invention and improvement of focused therapeutics, introduced it has submitted an Investigational New Drug (IND) software with the U.S. Meals and Drug Administration (FDA) for initiation of a Part 1/2 medical trial to guage IDE161, a small molecule inhibitor of poly (ADP-ribose) glycohydrolase (PARG), for the therapy of sufferers having stable tumors with homologous recombination deficiency (HRD).  

“IDE161 has a pretty preclinical profile, together with single-agent tumor regressions in PARP inhibitor-resistant BRCA1/2 xenograft fashions, and a positive preliminary preclinical myelosuppression security profile relative to sure accepted PARP inhibitors.  The IND submission for IDE161 is a big milestone for IDEAYA and displays our distinctive platform capabilities in artificial lethality for goal and biomarker identification, and drug discovery,” mentioned Michael White, Ph.D., Senior Vice President and Chief Scientific Officer, IDEAYA Biosciences.

“There stays a big unmet medical want for sufferers having tumors with homologous recombination deficiencies, reminiscent of BRCA1/2, and IDE161 has a possible alternative for medical differentiation in sufferers who’re non-responsive to PARP inhibitors or to platinum-based remedies,” mentioned 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 goal in the identical clinically validated pathway as poly (ADP-ribose) polymerase (PARP).  Topic to effectiveness of the IND following FDA overview, IDEAYA plans to guage the security, tolerability, pharmacokinetic and pharmacodynamic properties and preliminary efficacy of IDE161 as monotherapy in BRCA1/2-mutant breast and ovarian most cancers sufferers.

IDEAYA owns or controls all business rights in IDE161, topic to sure financial obligations pursuant to its unique, worldwide license with Most cancers Analysis UK and College of Manchester.

Extra data on IDE161, together with scientific insights and medical improvement alternatives, will likely 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 offered at https://ir.ideayabio.com/occasions or https://lifescievents.com/occasion/ideaya-rd-day/.  

About IDEAYA Biosciences

IDEAYA is an artificial lethality-focused precision drugs oncology firm dedicated to the invention and improvement of focused therapeutics for affected person populations chosen utilizing molecular diagnostics.  IDEAYA’s method integrates capabilities in figuring out and validating translational biomarkers with drug discovery to pick affected person populations almost certainly to learn from its focused therapies.  IDEAYA is making use of its early analysis and drug discovery capabilities to artificial lethality – which represents an rising class of precision drugs targets. 

Ahead-Wanting Statements

This press launch accommodates forward-looking statements, together with, however not restricted to, statements associated to (i) the timing and content material of the Investor R&D Day webcast, (ii) potential medical differentiation of IDE161, and (iii) the medical improvement plan for IDE161.   IDEAYA undertakes no obligation to replace or revise any forward-looking statements. For an extra description of the dangers and uncertainties that would trigger precise outcomes to vary from these expressed in these forward-looking statements, in addition to dangers referring to the enterprise of IDEAYA basically, see IDEAYA’s Quarterly Report on Type 10-Q filed on November 8, 2022 and any present and periodic experiences filed with the U.S. Securities and Alternate Fee.

Investor and Media Contact
IDEAYA Biosciences
Paul A. Stone
Senior Vice President and Chief Monetary Officer
[email protected]

SOURCE IDEAYA Biosciences, Inc.

IDEAYA Biosciences Pronounces Submission of IND Utility to the U.S. FDA for PARG Growth Candidate IDE161