SOUTH SAN FRANCISCO, Oct. 8, 2019 /PRNewswire/ -- IDEAYA Biosciences, Inc., an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, announces it has dosed its first patient with cutaneous melanoma harboring a GNAQ or GNA11 (GNAQ/11) mutation, a key milestone for evaluating Protein Kinase C (PKC) inhibitor IDE196 in solid tumors outside of metastatic uveal melanoma (MUM) as part of IDEAYA's ongoing Phase 1/2 clinical trial entitled "Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions" (ClinicalTrials.gov Identifier: NCT03947385).
IDEAYA previously announced initiation of this Phase 1/2 clinical trial evaluating IDE196 in a tissue-type agnostic basket trial for treatment of metastatic uveal melanoma and other solid tumors harboring GNAQ/11 mutations. "The extension of IDEAYA's clinical trial to treat patients having non-MUM tumors with GNAQ/11 hotspot mutations which activate the pathogenic PKC signaling pathway could be very meaningful. This may be particularly true in skin melanoma characterized by GNAQ/11 mutations. Such cases do not have actionable BRAF driver mutations and may also have a low tumor mutational burden and thus be less responsive to immuno-oncology agents," said Dr. Richard Carvajal, M.D., Director of Experimental Therapeutics and Director of the Melanoma Service, at Columbia University Medical Center.
In addition, IDEAYA entered into a collaboration with Foundation Medicine in support of IDEAYA's tissue-type agnostic strategy, which includes a genomic biomarker-driven approach to be enabled by FoundationOne® CDx™, Foundation Medicine's FDA-approved broad companion diagnostic which includes comprehensive genomic profiling against 324 genes. This relationship allows for genomic profiling of patient tumor samples from IDEAYA's ongoing Phase 1/2 clinical trial as well as advanced analyses of FoundationCORE™, Foundation Medicine's proprietary database of over 300,000 de-identified comprehensive genomic patient profiles.
"We are excited to evaluate IDE196 outside of metastatic uveal melanoma using a tissue-agnostic approach," said Dr. Julie Hambleton, M.D., Senior Vice President and Chief Medical Officer of IDEAYA. "We anticipate continued enrollment of patients having solid tumors with GNAQ/11 hotspot mutations outside of MUM, including potentially in cutaneous melanoma, colorectal cancer, and other solid tumors," continued Dr. Hambleton.
Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to (i) IDEAYA's ability to select patients likely to benefit from IDEAYA's targeted therapies, (ii) extension of IDEAYA's Phase 1/2 clinical trial to treat patients having non-MUM tumors with GNAQ/11 hotspot mutations which activate the pathogenic PKC signaling pathway, (iii) potential responsiveness of tumors characterized by GNAQ/11 mutations, including tumors which do not have actionable BRAF driver mutations and/or having low tumor mutational burden, and such tumors responsiveness to BRAF inhibitors or to immuno-oncology agents, and (iv) continued enrollment of patients having solid tumors with GNAQ/11 hotspot mutations outside of MUM. 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 August 12, 2019 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.
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 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 direct targeting of oncogenic pathways and synthetic lethality – which represents an emerging class of precision medicine targets.