Phase 1/2 Clinical Trial Progress for IDE196 to be Presented at Society for Melanoma Research Congress
- Update on Phase 1 Dose-Escalation portion of ongoing Phase 1/2 clinical trial, with specific focus on dosing schema, patient enrollment, and safety data, to be presented at SMR on November 20, 2019
- Phase 2 dose selection and expansion into Phase 2 portion of the clinical trial on track for Q4 2019
- Interim data, including clinical efficacy, expected in Q2/Q3 2020
SOUTH SAN FRANCISCO, Calif., Nov. 15, 2019 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, announced that it will present data from an ongoing Phase 1/2 clinical trial entitled "A Phase 1/2 Study in Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions" (ClinicalTrials.gov Identifier: NCT03947385). This clinical trial is evaluating the tolerability and preliminary clinical activity of IDE196 for the treatment of MUM and other solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations activating the PKC signaling pathway.
An update on the Phase 1 Dose-Escalation portion of the ongoing Phase 1/2 clinical trial will be provided, including:
- Dosing schema for dose escalation cohorts
- Patient enrollment by dose cohort
- Patient baseline characteristics
- Summary of adverse events
- Duration of treatment through data cut-off (October 28, 2019)
Data will be presented at the 16th International Congress for the Society for Melanoma Research (SMR Congress) at the Grand America Hotel in Salt Lake City, Utah, November 20-23, 2019.
Dr. Matteo Carlino, Medical Oncologist, Westmead Hospital and University of Australia, Westmead, Australia, will provide a poster presentation at the SMR Congress on November 20, 2019, entitled: "A phase 1/2 study of IDE196 in patients with metastatic uveal melanoma or solid tumors harboring GNAQ/11 mutations or PRKC fusions."
Dr. Meredith McKean, MD, MPH, Investigator, Melanoma Research Program at Sarah Cannon Research Institute, Nashville, TN, will provide an oral presentation, at a related meeting hosted by the Melanoma Research Foundation's CURE Ocular Melanoma (OM) initiative in conjunction with the SMR Congress, on November 20, 2019.
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.
This press release contains forward-looking statements, including, but not limited to, statements related to (i) update on Phase 1 Dose-Escalation portion of ongoing Phase 1/2 basket trial, (ii) Phase 2 dose selection and expansion for the IDE196 Phase 2 clinical trial, and (iii) release of interim data for the IDE196 Phase 1/2 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 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.
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SOURCE IDEAYA Biosciences, Inc.
Company Codes: NASDAQ-NMS:IDYA