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

Rhea-AI Summary

IDEAYA Biosciences (NASDAQ:IDYA) announced the First-Patient-In in a Phase 1 study evaluating the combination of IDE196 and binimetinib for metastatic uveal melanoma (MUM). This collaboration with Pfizer aims to enhance IDE196's clinical activity through rational combinations. The company is also focusing on IDE196's monotherapy in non-MUM settings. Preliminary data from the MEK combination study is expected in late 2021 to early 2022, potentially leading to a registrational path for MUM and future partnerships.

Positive

• Initiation of Phase 1 combination study for IDE196 and binimetinib.
• Collaboration with Pfizer for clinical trial and product supply.
• Focus on rational drug combinations enhances clinical strategy.

Negative

• Regulatory hurdles and uncertainties inherent in drug development.
• Risks associated with the early stage of clinical programs.

SOUTH SAN FRANCISCO, Calif., July 9, 2020 /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 binimetinib, a MEK inhibitor, in metastatic uveal melanoma (MUM).  The clinical combination of IDE196 and binimetinib is being evaluated by IDEAYA with binimetinib being supplied by Pfizer pursuant to a clinical trial collaboration and supply agreement.

In the MUM setting, IDEAYA's clinical development strategy focuses on rational combinations, including MEK, and supporting studies through collaborations, such as the Pfizer clinical trial collaboration and supply agreement.  IDEAYA's strategic objective is to enhance the clinical activity of IDE196 through potential synergistic combinations.  In the non-MUM GNAQ/11 hotspot mutation basket trial, including skin melanoma, IDEAYA will continue to evaluate IDE196 monotherapy and potential combinations, such as with binimetinib.

At the AACR Virtual Annual Meeting II held on June 22-24, 2020, IDEAYA presented an abstract on the preclinical evaluation of IDE196 plus MEK combination, entitled "Analysis of drug combinations with the PKC inhibitor IDE196 support dual MEK and PKC inhibition as a rational combination in metastatic uveal melanoma."

"Our preclinical studies with IDE196 and MEK presented at AACR support our clinical development strategy to focus on combinations as the most promising approach for the MUM indication," said Mick O'Quigley, Vice President, Head of Development Operations. "In addition, we continue to evaluate IDE196 monotherapy and potentially also combinations in the GNAQ/11 hotspot mutation basket trial, in non-MUM indications such as skin melanoma."

IDEAYA anticipates interim data from the MEK combination study in late 2021 to early 2022, at which time the company will evaluate a potential registrational path for MUM and a potential partnership. 

About IDEAYA Biosciences

IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of Synthetic Lethality-based therapeutics for patient populations selected using molecular diagnostics.  IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including 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 results of combinations of IDE196 and other agents in both the MUM indication and non-MUM indications and (ii) the timing of interim data from the MEK combination study. 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 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 May 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 Phase 1 study involving IDE196 and binimetinib?

The Phase 1 study aims to evaluate the safety and efficacy of the combination of IDE196 and binimetinib in treating metastatic uveal melanoma.

When can we expect interim data from the IDE196 and binimetinib study?

Interim data from the study is anticipated in late 2021 to early 2022.

What are the implications of the collaboration with Pfizer for IDEAYA?

The collaboration with Pfizer is expected to enhance IDEAYA's clinical development strategy through shared resources and expertise in drug supply.

What are the potential market impacts of the Phase 1 combination study results?

Successful results could lead to a registrational path for IDE196 in metastatic uveal melanoma, potentially increasing market interest and investment.