IDEAYA Biosciences Announces Clinical Program Updates for IDE397, a Potential Phase 2 MAT2A Inhibitor Targeting MTAP Deletion Solid Tumors

• Targeting Updated Clinical Data of Phase 2 Monotherapy Expansion Dose of IDE397 in More Than Approximately 15 Evaluable MTAP Lung and Bladder Cancer Patients in second half 2024, including RECIST 1.1 clinical efficacy cascade, swim lane tracing, cDNA molecular response analysis, AE profile, pharmacokinetics and pharmacodynamics
• Initiation of Phase 2 monotherapy expansion of IDE397 in MTAP bladder cancer, in addition to previously reported Phase 2 expansion in MTAP lung squamous cell cancer
• Activation of more than 35 clinical trial sites worldwide in the United States, Canada, EuropeAnd Asia Pacific to enable potential rapid recruitment for the IDE397 phase 2 clinical program

SOUTH SAN FRANCISCO, CA., June 24, 2024 /PRNewswire/ — IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company engaged in the discovery and development of targeted treatments, today announced clinical program updates for IDE397 , a potential first-in-class phase 2 MAT2A inhibitor. targeting solid tumors with MTAP deletion.

“We are excited to activate more than 35 clinical trial sites globally and advance the IDE397 Phase 2 program at scale, including multiple potential first-in-class clinical combinations and expansion of phase 2 monotherapy in priority types of solid lung and bladder tumors with MTAP deletion. We are pleased to provide updated corporate guidance for the IDE397 clinical program, including an updated clinical date for the Phase 2 monotherapy expansion dose of IDE397 in the second half of 2024.” , said Yujiro S. HataCEO of IDEAYA Biosciences.

The Company is now targeting an update of IDE397 clinical data for phase 2 monotherapy dose expansion of IDE397 in bladder and lung cancer with MTAP deletion in more than 15 evaluable patients over the course of of the second half of 2024. The update of clinical data should include an assessment of clinical effectiveness. summary, including a RECIST 1.1 clinical efficacy cascade, lane plot, and cDNA molecular response analysis. Additionally, during this update, the Company also plans to provide a summary of adverse events, pharmacokinetics and pharmacodynamics of the Phase 2 monotherapy dose expansion of IDE397. Next, the Company is launching a Phase 2 expansion of IDE397 as a single agent in MTAP deletion bladder cancer, in addition to the previously reported Phase 2 expansion in MTAP deletion squamous cell lung cancer. The Company has activated more than 35 clinical trial sites worldwide in the United States, Canada, EuropeAnd Asia Pacific to enable potential rapid recruitment for phase 2 monotherapy expansion of IDE397 in MTAP deletion lung and bladder cancer, and for IDEAYA-sponsored clinical combination(s).

IDE397 is a potential first-in-class, potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2 alpha (MAT2A) in patients with solid tumors with deletion of methylthioadenosine phosphorylase (MTAP).

There is an ongoing Phase 2 expansion of IDE397 monotherapy in MTAP-deletion solid tumors (NCT04794699) and an Amgen-sponsored Phase 1/2 trial of the combination of IDE397 and AMG 193 in MTAP-deletion NSCLC (NCT05975073) for which the companies intend to develop a joint publication strategy in 2024. Next, there will be a Phase 1 clinical trial that will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in association with Trodelvy (NCT04794699). IDEAYA is also advancing several MTAP knockdown programs to the preclinical stage to enable proprietary combinations with IDE397, including a program targeting development candidate nomination in the second half of 2024.

About IDEAYA Biosciences

IDEAYA is a precision medicine oncology company engaged in the discovery and development of targeted treatments for selected patient populations using molecular diagnostics. IDEAYA’s approach integrates translational biomarker identification and validation capabilities with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA applies its research and drug discovery capabilities to synthetic lethality, which represents an emerging class of targets in precision medicine.

Forward-looking statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) the timing and content of clinical program updates and (ii) the timing of strategy development joint Amgen/IDEAYA publication. These forward-looking statements involve significant risks and uncertainties that could impact IDEAYA’s preclinical and clinical development programs and forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including the early stages of development of IDEAYA’s programs, the process of designing and conducting preclinical and clinical trials, the approval processes regulatory filings, the timing of regulatory filings, the challenges associated with manufacturing pharmaceutical products, IDEAYA’s ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the adequacy of existing liquidity to finance operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a more detailed 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 IDEAYA’s business generally, see IDEAYA’s annual report on form 10-K dated February 20, 2024 and all current and periodic reports filed with the United States Securities and Exchange Commission.

Investor and media contact

IDEAYA Biosciences
Andres Ruiz Briseno
Senior Vice President, Head of Finance and Investor Relations
(email protected)

IDEA SOURCEYA Biosciences, Inc.