IDEAYA Biosciences Announces IND Submission for IDE574, a Potential First-In-Class KAT6/7 Dual Inhibitor for Breast and Lung Cancers

• Phase 1 dose escalation trial of monotherapy IDE574 expected to begin in 1Q 2026
• Targeting to present preclinical data detailing pharmacologic profile and evidence of anti-tumor activity in solid tumor models at a medical conference in 1H 2026

SOUTH SAN FRANCISCO, Calif., Dec. 10, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IDE574, a potential first-in-class KAT6/7 dual inhibitor with high selectivity over related KAT5/8 enzymes. The company is targeting to begin a Phase 1 dose escalation trial of monotherapy IDE574 in the first quarter of 2026. 

"IDE574 is a promising potential first-in-class molecule that potently inhibits two tumor-promoting epigenetic modulators, KAT6 and KAT7, while sparing other structurally similar KAT family members. Preclinical studies demonstrate KAT6 and KAT7 collaboratively control lineage-specific tumorigenic transcription factor activity essential for tumor cell proliferation and survival. Dual KAT6/7 inhibition by IDE574 disrupts tumor lineage identity and delivers robust anti-tumor activity in patient-derived lung and breast cancer xenograft models dependent upon lineage-specific transcription factor activity," said Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences.

IDE574 is an equipotent, highly selective, small molecule dual inhibitor of the lysine acetyltransferase (KAT) 6 and 7, both of which have been shown to support cancer cell survival. IND-enabling studies support the potential clinical evaluation of IDE574 monotherapy in patients with hormone receptor-positive breast cancer, lung adenocarcinoma as well as additional opportunities associated with lineage addiction. IDEAYA is targeting to share data from its preclinical work with IDE574 at a medical conference in the first half of 2026. 

About IDEAYA Biosciences

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to (i) the potential therapeutic benefits of IDE574, including combination therapies; (ii) the timing of initiating a Phase 1 dose escalation trial of monotherapy IDE574 and (iii) the timing of presenting pre-clinical data at a medical conference for IDE574. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs in early or late stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's Annual Report on Form 10-K dated February 18, 2025 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

Investor and Media Contact

IDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
[email protected]

SOURCE IDEAYA Biosciences, Inc.