IDEAYA Announces Dose Expansion in Phase 1/2 Study of IDE196 and Binimetinib Combination in Metastatic Uveal Melanoma Based on Early Clinical Activity
IDEAYA Biosciences, Inc. (NASDAQ: IDYA) announced a dose expansion of its Phase 1/2 study evaluating the combination of IDE196 and binimetinib in metastatic uveal melanoma (MUM). Early clinical activity has shown promise, with plans to enroll approximately 40 patients. IDEAYA received a Notice of Allowance for a U.S. patent covering this combination therapy. The company targets interim data updates in 2021, including tolerability and clinical efficacy from both the combination and monotherapy arms, which may reveal clinical activity independent of HLA status.
- Successful early clinical activity of IDE196 and binimetinib in MUM.
- Initiation of dose expansion to enroll approximately 40 patients.
- Notice of Allowance for U.S. patent covering IDE196 and MEK combination therapy.
- Risks inherent in drug development may affect trial timelines and outcomes.
- Uncertainties related to manufacturing drug products.
- Challenges related to regulatory approval processes.
SOUTH SAN FRANCISCO, Calif., March 23, 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 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.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) targeted enrollment in the combination study, (ii) IDE196 activity with respect to HLA status, (iii) the timing and content of release of interim data for the IDE196/binimetinib combination arm of the clinical trial, and (iv) the timing and content of release of interim data for the IDE196 monotherapy arm of the Phase 1/2 GNAQ/11 basket trial. 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 Annual Report on Form 10-K filed on March 23, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.
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SOURCE IDEAYA Biosciences, Inc.
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