IDEAYA Biosciences Doses First Patient in a Phase 1 Combination Study of IDE196 and Crizotinib, a cMET Inhibitor

Rhea-AI Summary

IDEAYA Biosciences (Nasdaq:IDYA) announced the First-Patient-In (FPI) in a Phase 1 combination study of IDE196 and crizotinib for metastatic uveal melanoma (MUM). This collaboration with Pfizer aims to evaluate the effectiveness of IDE196 alongside the cMET inhibitor crizotinib. IDEAYA's translational research identified cMET as a potential combination agent. The company plans to present preclinical data supporting the IDE196/crizotinib therapy in H1 2021, addressing a significant unmet medical need in treating MUM.

Positive

• Initiation of Phase 1 combination study for IDE196 and crizotinib.
• Collaboration with Pfizer enhances clinical study credibility.
• High unmet medical need for MUM, potentially large market opportunity.

Negative

• None.

SOUTH SAN FRANCISCO, Calif., Jan. 5, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, announced First-Patient-In (FPI) in the Phase 1 combination study of IDE196 and crizotinib, a cMET inhibitor, in metastatic uveal melanoma (MUM). The clinical combination of IDE196 and crizotinib is being evaluated by IDEAYA in collaboration with Pfizer pursuant to a clinical trial collaboration and supply agreement.

"IDEAYA is executing on its clinical trial strategy to evaluate IDE196 combination therapies in Metastatic Uveal Melanoma (MUM). We identified cMET as a potential combination agent through our translational research, including evaluation of cMET expression in MUM patient clinical samples from an IDE196 Phase 1 clinical trial and preclinical demonstration of synergy between IDE196 and crizotinib, going from bench to bedside in approximately one year," said Mick O'Quigley, Vice President, Head of Development Operations. IDEAYA plans to present preclinical translational data supporting the IDE196/crizotinib combination therapy in H1 2021.

"IDEAYA's clinical trials evaluating IDE196 plus either crizotinib or binimetinib as combination therapies are each based on compelling biological rationale for treating patients with metastatic uveal melanoma – a solid tumor for which there is a high unmet medical need and currently no approved therapies," said Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology.

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, statements related to the timing of presentation of preclinical translational data supporting the IDE196 / crizotinib combination therapy.  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.

View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-doses-first-patient-in-a-phase-1-combination-study-of-ide196-and-crizotinib-a-cmet-inhibitor-301199950.html

SOURCE IDEAYA Biosciences, Inc.

FAQ

What is the purpose of the Phase 1 study involving IDE196 and crizotinib?

The purpose is to evaluate the efficacy of IDE196 in combination with the cMET inhibitor crizotinib for treating metastatic uveal melanoma.

When will IDEAYA present data from the IDE196/crizotinib study?

IDEAYA plans to present preclinical translational data supporting the combination therapy in the first half of 2021.

What is the significance of the collaboration with Pfizer?

The collaboration with Pfizer is significant as it enhances the clinical trial's credibility and resource sharing.

Why is there a high unmet medical need in metastatic uveal melanoma?

There are currently no approved therapies for metastatic uveal melanoma, highlighting the need for effective treatment options.

What are the potential risks mentioned in the press release?

Risks include uncertainties in drug development, regulatory processes, and the impact of the COVID-19 pandemic on operations.