IDEAYA Biosciences Announces Development Candidate Nomination of IDE101, a Potential First-In-Class Inhibitor Targeting CDKN2A-Deficiency in Solid Tumors

• Development candidate demonstrates encouraging preclinical activity in CDKN2A-deficienct tumor models as a monotherapy and in combination with inhibitors of RAS and MTAP, including IDEAYA's proprietary Phase 1 PRMT5 inhibitor IDE892
  
  
• CDKN2A-deficiency is a common tumor suppressor loss prevalent in ~10-15% of all solid tumors, including ~70% of pancreatic cancer
  
  
• IDE101's preclinical profile, including combination results with inhibitors of PRMT5 and pan-RAS, will be summarized at IDEAYA's London R&D Day
  
  
• IND-enabling studies underway to support an IND filing in H1 2027

SOUTH SAN FRANCISCO, Calif., Nov. 15, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, today announced development candidate nomination of IDE101, a potential first-in-class dual cyclin-dependent kinase (CDK) inhibitor designed to address the loss of CDKN2A-mediated tumor suppressor function in cancer. CDKN2A-deficiency occurs in approximately 10-15% of all solid tumors, including ~70% of pancreatic ductal adenocarcinoma (PDAC), and is typically co-deleted in methylthioadenosine phosphorylase (MTAP)-deficient cancers given their proximity on chromosome 9p21.

"We are excited to announce the nomination of IDE101 as our next development candidate in our precision medicine pipeline. IDE101 is a novel, first-in-class molecule that targets the key drivers of tumorigenesis resulting from CDKN2A-deficiency. We plan to focus development of IDE101 in tumors with a high frequency of CDKN2A-deficiency, including as a monotherapy agent and in combination with RAS inhibitors for pancreatic cancer and in combination with IDE892, our proprietary PRMT5 inhibitor, in MTAP-deleted solid tumors. We believe there is strong potential to drive better efficacy in these cancers by co-targeting tumor suppressor loss with IDE101 and key driver oncogene dependencies, such as KRAS, through rational combinations," said Dr. Michael White, President of Research and Development at IDEAYA Biosciences. "We are pushing ahead with urgency to complete the IND-enabling work necessary to support an IND filing in the first half of next year."

IDE101 was discovered through IDEAYA's iterative physics-based ligand design and optimization platform and is a highly potent and selective dual CDK inhibitor with first-in-class potential and favorable drug-like properties. IND-enabling studies for IDE101 are ongoing to support an Investigational New Drug (IND) filing to the U.S. Food and Drug Administration (FDA) in the first half of 2027, subject to satisfactory completion of ongoing preclinical and IND-enabling studies.

About IDEAYA Biosciences

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies to address unmet medical needs in cancer. The company integrates small-molecule drug discovery, structural biology and bioinformatics with extensive capabilities in identifying and validating translational biomarkers to develop potentially first-in-class targeted therapies for selected patient populations. IDEAYA has built a robust pipeline of targeted therapies focused on synthetic lethality and antibody-drug conjugates, or ADCs, including bispecifics, with the goal of improving clinical outcomes for patients with cancer.

Forward-Looking This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the development plans for IDE101; its potential first-in-class and best-in-class profile, selectivity, drug-like properties and therapeutic benefits; the potential of IDE101 as a monotherapy and in combination with other therapies, including RAS inhibitors and IDEAYA's proprietary PRMT5 inhibitor IDE892; the potential to improve efficacy through co-targeting CDKN2A-deficiency and oncogenic dependencies; the potentially addressable patient populations for IDE101; the timing, progress and results of preclinical and IND-enabling studies; the anticipated submission of an Investigational New Drug application to the FDA in the first half of 2027; and the timing and content of presentations at IDEAYA's London R&D Day.

These forward-looking statements are based on management's current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Such risks and uncertainties include, among others, the uncertainties inherent in drug discovery and development; the possibility that preclinical findings may not predict clinical safety, efficacy or therapeutic benefit; unexpected toxicities or other findings that could delay or prevent further development of IDE101, alone or in combination; delays in completing preclinical and IND-enabling studies, manufacturing clinical supplies or submitting regulatory applications; regulatory requirements, actions or decisions that could delay or prevent initiation of clinical trials; competition and changes in the treatment landscape; IDEAYA's ability to obtain, maintain and protect intellectual property rights; the availability of sufficient funding and other resources; and other risks described in IDEAYA's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q.

The forward-looking statements speak only as of the date of this press release. IDEAYA undertakes no obligation to update any forward-looking statements, except as required by law.

Investor and Media Contact

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

SOURCE IDEAYA Biosciences, Inc.