IDEAYA Announces First Patient Dosing of IDE196 for Solid Tumors outside of Uveal Melanoma and a Collaboration with Foundation Medicine in support of its Tumor-Agnostic GNAQ/11 Basket Trial

SOUTH SAN FRANCISCO, CA, USA I October 8, 2019 I 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.

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.

SOURCE: IDEAYA Biosciences

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