IDEAYA Biosciences Announces IND Submission for IDE892, a Potential Best-In-Class PRMT5 Inhibitor for MTAP-Deletion Solid Tumors

Rhea-AI Summary

IDEAYA Biosciences (NASDAQ:IDYA) has submitted an Investigational New Drug (IND) application to the FDA for IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor targeting MTAP-deletion solid tumors. The company plans to initiate a Phase 1 dose escalation trial in MTAP-deleted lung cancer in Q4 2025.

The clinical development strategy includes advancing to combination trials with IDE397, IDEAYA's proprietary MAT2A inhibitor, in H1 2026. The target market is significant, with 15-20% of non-small cell lung cancer (NSCLC) cases being MTAP-deleted. The company will also evaluate IDE892 in other MTAP solid tumor indications, both as monotherapy and in combination with IDE397.

Positive

• None.

Negative

• Early-stage development with IND just submitted, significant time to market
• Will require extensive clinical trials to prove efficacy and safety
• Faces competition in the PRMT5 inhibitor space

• Dosing of first patient in Phase 1 dose escalation trial of IDE892 targeted in 4Q 2025
• Preclinical profile of IDE892 and mechanistic combination rationale with IDE397, IDEAYA's proprietary MAT2A inhibitor, will be presented at the 10-Year Anniversary R&D Day on September 8^th

SOUTH SAN FRANCISCO, Calif., Sept. 3, 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 IDE892, a potential best-in-class MTA-cooperative inhibitor of PRMT5. The company is targeting to begin a Phase 1 dose escalation trial of IDE892 in MTAP-deleted lung cancer in the fourth quarter of 2025, with the goal of advancing into combination trials with IDE397, IDEAYA's proprietary MAT2A inhibitor, in the first half of 2026.

Approximately 15-20% of non-small cell lung cancer (NSCLC) is MTAP-deleted. Extensive studies indicate that elevated MTA/SAM ratios in MTAP-deleted cancers create a tumor-specific vulnerability to MTA-cooperative PRMT5 inhibition. This effect is substantially enhanced in combination with MAT2A inhibition, leading to an important combination therapy opportunity in an area of substantial unmet need. In addition to MTAP-deleted lung cancer, IDEAYA will target to clinically evaluate other high priority MTAP solid tumor indications as both IDE892 monotherapy and in combination with IDE397.

"We are excited to advance IDE892 into clinical studies for patients with MTAP-deleted lung cancer, where we believe the inhibition of PRMT5 in combination with MAT2A could have synergistic anti-tumor activity," said Michael White, Chief Scientific Officer, IDEAYA Biosciences. "IDE892 is the culmination of a comprehensive optimization of the biophysical and pharmacokinetic properties required to maximize therapeutic benefit as a combination partner with IDE397, and to generate a potential best-in-class MTA-cooperative PRMT5 inhibitor profile."

Registration for IDEAYA's 10-Year Anniversary R&D Day can be accessed here or at the investors section of the IDEAYA website at https://ir.ideayabio.com/events.

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 IDEAYA therapeutics, including combination therapies; (ii) the timing and content of IDEAYA's 10-Year Anniversary R&D Day; (iii) the timing of dosing of first patient in Phase 1 dose escalation trial for IDE892; (iv) the timing of initiating studies for IDE892/IDE397 combination; and (v) the estimated occurrence of MTAP-deletion in NSCLC. 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
investor@ideayabio.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-ind-submission-for-ide892-a-potential-best-in-class-prmt5-inhibitor-for-mtap-deletion-solid-tumors-302544319.html

SOURCE IDEAYA Biosciences, Inc.

FAQ

What is the significance of IDEAYA's IDE892 IND submission for MTAP-deletion tumors?

IDE892 is a potential best-in-class PRMT5 inhibitor targeting MTAP-deleted tumors, with Phase 1 trials expected to begin in Q4 2025. It represents a significant advancement in IDEAYA's oncology pipeline.

How many lung cancer patients could potentially benefit from IDYA's IDE892 treatment?

Approximately 15-20% of non-small cell lung cancer (NSCLC) patients have MTAP-deletion, representing the initial target population for IDE892 treatment.

When will IDEAYA (IDYA) begin combination trials of IDE892 with IDE397?

IDEAYA plans to begin combination trials of IDE892 with IDE397 (their MAT2A inhibitor) in the first half of 2026, following initial Phase 1 dose escalation trials.

What is the mechanism of action for IDEAYA's IDE892 drug?

IDE892 is an MTA-cooperative PRMT5 inhibitor that targets elevated MTA/SAM ratios in MTAP-deleted cancers, creating a tumor-specific vulnerability that can be enhanced when combined with MAT2A inhibition.

What are the next clinical development steps for IDEAYA's IDE892?

Following the IND submission, IDEAYA plans to initiate a Phase 1 dose escalation trial in MTAP-deleted lung cancer in Q4 2025, followed by expansion into other MTAP solid tumor indications.