IDEAYA Biosciences Announces Submission of IND Application for MAT2A Development Candidate IDE397 with the U.S. FDA

Rhea-AI Summary

IDEAYA Biosciences (Nasdaq:IDYA) has submitted an Investigational New Drug (IND) application to the FDA for IDE397, a MAT2A inhibitor aimed at treating solid tumors with MTAP deletion. This marks a significant milestone in IDEAYA's research pipeline focused on synthetic lethality therapies. Approximately 15% of solid tumors have the MTAP deletion, representing a potential patient population for IDE397. IDEAYA will share further details at the 39th Annual J.P. Morgan Healthcare Conference, including preclinical data showing tumor regressions and proposed clinical plans.

Positive

• Submission of IND application for IDE397 represents a significant milestone.
• Potential addressable market includes approximately 15% of solid tumors with MTAP deletion.
• Preclinical data indicates IDE397 shows promise in tumor regression for multiple solid tumor types.

Negative

• None.

SOUTH SAN FRANCISCO, Calif., Jan. 11, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, today announced it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE397, a small molecule methionine adenosyltransferase 2a (MAT2A) inhibitor, for the treatment of patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion.

"The IDE397 IND submission is an important milestone for IDEAYA as we advance our broader synthetic lethality pipeline of potential first-in-class therapies. IDE397 was discovered through our efforts to develop a potential best-in-class MAT2A inhibitor, and we have achieved our target product profile," said Michael Dillon, Ph.D., Chief Scientific Officer, IDEAYA Biosciences. "IDE397 is highly selective and active in the MTAP-deletion setting, which represents approximately 15% of all solid tumors, and we are excited about the potential impact IDE397 can make for these patients," said Yujiro S. Hata, Chief Executive Officer, IDEAYA Biosciences.

IDEAYA Biosciences will present a program update on IDE397 and its broader synthetic lethality pipeline at the 39^th Annual J.P. Morgan Healthcare Conference.  The presentation will include preclinical data demonstrating IDE397 monotherapy tumor regressions in PDX models with MTAP-deletion across several solid tumor types.  IDEAYA will also present its proposed IDE397 Phase 1 clinical plan in MTAP-deleted solid tumors, including monotherapy and combination strategies, and discuss the combination rationale for IDE397 and GSK's Type I PRMT inhibitor GSK3368715.  

IDEAYA's presentation for the 39^th Annual J.P. Morgan Healthcare Conference is available at https://ir.ideayabio.com/.

About IDEAYA Biosciences
IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics.  IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies.  IDEAYA is applying its early research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.   

Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to the potential impact of IDE397.  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' early 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, the effects on IDEAYA's business of the worldwide COVID-19 pandemic, 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 recent Quarterly Report on Form 10-Q filed on November 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

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SOURCE IDEAYA Biosciences, Inc.

FAQ

What is the significance of IDEAYA's IND application for IDE397?

The IND application is a crucial milestone for IDEAYA, allowing them to initiate a Phase 1 clinical trial for IDE397, a MAT2A inhibitor targeting solid tumors with MTAP deletion.

When will IDEAYA present updates on IDE397?

IDEAYA will present updates on IDE397 at the 39th Annual J.P. Morgan Healthcare Conference.

What percentage of solid tumors have MTAP deletion?

Approximately 15% of all solid tumors are estimated to have MTAP deletion, making them potential candidates for treatment with IDE397.

What kind of data will be presented at the J.P. Morgan Healthcare Conference?

IDEAYA will present preclinical data demonstrating tumor regressions in PDX models and discuss the clinical plan for IDE397, including monotherapy and combination strategies.