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IDEAYA Announces IDE397 IND Clearance by U.S. FDA to Initiate Phase 1 and Appointment of Matthew Maurer, M.D., as Vice President, Head of Clinical Oncology and Medical Affairs

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IDEAYA Biosciences (NASDAQ: IDYA) announced the successful IND application for IDE397, a MAT2A inhibitor, enabling a Phase 1 clinical trial for cancer patients with MTAP deletion, found in 15% of solid tumors. The trial is set to begin in Q1 2021. Additionally, Matthew Maurer, M.D., has joined as Vice President, bringing over 15 years of oncology experience. His expertise will support the advancement of IDE397 and the company's PARG program. The announcement highlights IDEAYA's commitment to targeted therapeutics in precision medicine and the ongoing development of its synthetic lethality pipeline.

Positive
  • IND application for IDE397 approved, allowing Phase 1 trial to commence.
  • First-Patient-In for the trial targeted for Q1 2021.
  • Appointment of Matthew Maurer, M.D., as VP of Clinical Oncology strengthens leadership.
Negative
  • None.

SOUTH SAN FRANCISCO, Calif., Feb. 8, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the effectiveness of the Investigational New Drug (IND) application for a Phase 1 clinical trial to evaluate IDE397, a potential best-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor. 

IDE397 is IDEAYA's most advanced synthetic lethality program, and being developed in the clinic for cancer patients harboring methylthioadenosine phosphorylase (MTAP) deletion, which is prevalent in approximately 15% of all solid tumors.  IDEAYA is targeting a Q1 2021 First-Patient-In for the Phase 1 clinical trial of IDE397 in patients having solid tumors harboring MTAP deletion.

IDEAYA also announced that Matthew Maurer, M.D., has joined the company as Vice President, Head of Clinical Oncology and Medical Affairs.  "Matt brings extensive clinical development and oncology experience in both the pharmaceutical industry and academia. His background in clinical oncology will be invaluable as we advance IDE397 clinically in MTAP-deletion and target to select the Development Candidate for our wholly-owned PARG program in 2021," said Yujiro S. Hata, President and Chief Executive Officer at IDEAYA Biosciences.

Dr. Maurer has over 15 years of experience in oncology and previously worked at Bristol Myers Squibb (BMS) where he most recently led the clinical development of nivolumab and ipilimumab late phase studies in renal cell carcinoma and prostate cancer.  Prior to BMS, Dr. Maurer was a physician investigator and Assistant Professor of Medicine at Columbia University College of Physicians and Surgeons, where he served as a breast cancer specialist.  Dr. Maurer obtained his undergraduate degree from Princeton University and his medical degree from Mount Sinai School of Medicine, and then completed his residency at Columbia University Medical Center. 

"I am thrilled to join the IDEAYA team and look forward to advancing the IDE397 clinical program and the broader Synthetic Lethality pipeline, including the PARG program, which has a potential application in breast cancer, an indication in which I have clinical experience as an oncologist," said Matthew Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs at IDEAYA Biosciences.

An updated corporate presentation is available on IDEAYA's website at the Investor Relations page. See: https://ir.ideayabio.com/.

About IDEAYA Biosciences
IDEAYA is a synthetic lethality-focused precision medicine oncology 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, statements related to (i) the timing of the First-Patient-In for IDE397 Phase 1 study and (ii) potential applications of the PARG program.  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 purpose of the IDE397 Phase 1 clinical trial?

The IDE397 Phase 1 clinical trial aims to evaluate the safety and efficacy of IDE397, a MAT2A inhibitor, in cancer patients with MTAP deletion.

When is the first patient expected to be enrolled in the IDE397 trial?

The first patient is expected to be enrolled in the IDE397 trial in Q1 2021.

Who has been appointed as Vice President at IDEAYA Biosciences?

Matthew Maurer, M.D., has been appointed as Vice President, Head of Clinical Oncology and Medical Affairs.

What is the significance of MTAP deletion in solid tumors?

MTAP deletion is prevalent in approximately 15% of solid tumors and is a key target for IDE397's therapeutic approach.

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