SOUTH SAN FRANCISCO, Calif. – IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced dose expansion of the ongoing Phase 1/2 study (ClinicalTrials.gov Identifier: NCT03947385) evaluating the combination of IDE196 and binimetinib in metastatic uveal melanoma (MUM). IDEAYA is the sponsor of this combination study, which is being conducted pursuant to a clinical trial collaboration and drug supply agreement with Pfizer. IDE196 is IDEAYA’s clinical stage protein kinase C, or PKC, inhibitor and binimetinib is a MEK inhibitor to which Pfizer has exclusive rights in the U.S. and Canada.
“Metastatic Uveal Melanoma is a high unmet medical need with no FDA approved therapies, and we are encouraged by the early clinical activity observed from the IDE196 and binimetinib combination,” said Dr. Richard Carjaval, M.D., Director of Experimental Therapeutics and Director of the Melanoma Service, Columbia University Medical Center. “The Phase 1/2 dose expansion of the IDE196 and binimetinib combination study and the notice of allowance for the U.S. patent application directed to IDE196 and MEK combination therapy are important company milestones, and we look forward to further evaluating the clinical potential of this combination,” said Yujiro S. Hata, Chief Executive Officer and President, IDEAYA Biosciences.
The IDE196 and binimetinib combination initiated dose expansion based on early clinical activity, including percentage of patients with tumor reduction. The IDE196 and binimetinib combination arm will target to enroll approximately 40 patients in the Phase 1/2 study in MUM. IDEAYA received a Notice of Allowance of U.S. Patent Application No. 16/666,108 covering methods of treating certain cancer types, including metastatic uveal melanoma, uveal melanoma and melanoma using a combination of IDE196 and a MEK inhibitor. Based on the preliminary IDE196 monotherapy clinical data and its mechanism of action, IDEAYA anticipates clinical activity independent of Human Leukocyte Antigen (HLA) status in GNAQ/11-mutation cancers.
IDEAYA is targeting interim data from the IDE196 and binimetinib clinical combination arm in MUM and from the IDE196 monotherapy arm of the Phase 1/2 basket trial in MUM and GNAQ/11-mutation skin melanoma in 2021. As part of the IDE196 monotherapy clinical data update in 2021, IDEAYA is targeting to report tolerability and clinical efficacy, including survival data in MUM.
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.
Investor and Media: IDEAYA Biosciences, Paul Stone, Chief Financial Officer, [email protected]