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

Rhea-AI Summary

IDEAYA Biosciences (IDYA) nominated IDE101 as a development candidate targeting cancers with loss of the tumor-suppressing function of CDKN2A. The dual cyclin-dependent kinase (CDK) inhibitor has shown preclinical activity alone and in combinations.

The company plans development in pancreatic cancer with RAS inhibitors and in MTAP-deleted solid tumors with its PRMT5 inhibitor IDE892. Studies needed before requesting human trials are underway to support an Investigational New Drug filing in the first half of 2027, subject to satisfactory completion of ongoing preclinical and supporting studies.

4 points · 0 major

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0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointIDE101 development candidate nomination advances a program targeting CDKN2A-deficient cancers.
• Minor pointPreclinical activity demonstrated in tumor models as monotherapy and in combinations.
• Minor point. Forward-looking: it has not happened yet and may not happen.Planned development includes pancreatic cancer combinations with RAS inhibitors and MTAP-deleted tumor combinations with IDE892.
• Minor point. Forward-looking: it has not happened yet and may not happen.IND-enabling studies underway to support a planned filing in the first half of 2027.

Negative

• Minor point. Forward-looking: it has not happened yet and may not happen.Planned first-half 2027 IND filing depends on satisfactory completion of ongoing preclinical and IND-enabling studies.

Key Figures

Solid tumor prevalence: approximately 10-15% Pancreatic cancer prevalence: ~70% Planned IND filing: first half of 2027

Solid tumor prevalence

approximately 10-15%

CDKN2A-deficiency across all solid tumors

Pancreatic cancer prevalence

~70%

CDKN2A-deficiency in pancreatic ductal adenocarcinoma

Planned IND filing

first half of 2027

Subject to satisfactory completion of ongoing preclinical and IND-enabling studies

Key Terms

cdkn2a-deficiency, cyclin-dependent kinase, pancreatic ductal adenocarcinoma, methylthioadenosine phosphorylase, +1 more

5 terms

cdkn2a-deficiency medical

"loss of CDKN2A-mediated tumor suppressor function in cancer"

Loss or inactivation of the CDKN2A gene, which normally produces proteins that slow cell division (notably p16INK4a and p14ARF); when the gene is deleted, mutated, or epigenetically silenced in a tissue, cells lose that checkpoint control, making unchecked proliferation and tumor development more likely. CDKN2A-deficiency can occur as a hereditary (germline) alteration or as an acquired (somatic) change in tumors and is used clinically as a biomarker for cancer risk, prognosis, and responsiveness to some therapies, with effects that vary by cancer type and the specific molecular change.

cyclin-dependent kinase medical

"a potential first-in-class dual cyclin-dependent kinase (CDK) inhibitor"

A cyclin-dependent kinase (CDK) is a member of a family of protein enzymes that control progression through the cell cycle by adding phosphate groups to specific target proteins; each CDK must bind a regulatory partner called a cyclin and often be further activated by phosphorylation to become active. Different CDKs pair with different cyclins at particular cell-cycle stages, and their activity is tightly regulated by cyclin levels, inhibitory proteins and phosphorylation state, so CDKs drive stage-specific events like DNA replication and mitosis rather than acting continuously.

pancreatic ductal adenocarcinoma medical

"including ~70% of pancreatic ductal adenocarcinoma (PDAC)"

A fast-growing cancer that starts in the cells lining the pancreas’ small ducts; it is the most common and aggressive form of pancreatic cancer. It matters to investors because its severity and limited treatment options drive high unmet medical need, large potential markets for effective drugs or diagnostics, and strong sensitivity of company valuations to clinical trial results, regulatory approvals, or changes in treatment guidelines—similar to how fixing a main leak can prevent major damage in a building.

methylthioadenosine phosphorylase medical

"methylthioadenosine phosphorylase (MTAP)-deficient cancers"

An enzyme that breaks down methylthioadenosine (MTA) by splitting it with inorganic phosphate to produce adenine and methylthioribose-1-phosphate; this reaction is a key step in the cellular salvage pathways for methionine and polyamine metabolism. It operates inside cells, and changes in its activity affect levels of MTA and connected metabolic pathways, which is why it is studied in medical and biochemical contexts.

investigational new drug regulatory

"Investigational New Drug (IND) filing to the U.S. Food and Drug Administration"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

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• 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
investor@ideayabio.com

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SOURCE IDEAYA Biosciences, Inc.

FAQ

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What is IDEAYA's IDE101 development candidate targeting?

IDE101 is a dual cyclin-dependent kinase inhibitor designed to address the loss of CDKN2A-mediated tumor-suppressing function in cancer. IDEAYA plans to develop it alone and in combinations, including with RAS inhibitors for pancreatic cancer and IDE892 for MTAP-deleted solid tumors.

When does IDEAYA plan to file an IND for IDE101?

IDEAYA plans an Investigational New Drug filing in the first half of 2027. That timing is subject to satisfactory completion of ongoing preclinical studies and the supporting studies needed for the application to the U.S. Food and Drug Administration.