On December 9, 2019 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, reported further progress on key elements of its 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) (Press release, Ideaya Biosciences, DEC 9, 2019, View Source [SID1234552167]). This clinical trial is evaluating the tolerability and preliminary clinical activity of IDE196 for the treatment of Metastatic Uveal Melanoma (MUM) and other solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations activating the PKC signaling pathway.
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"The pharmacokinetic clinical sub-study for the tablet formulation is on-track to start in January 2020. This may enable the initiation of the Phase 2 expansion to coincide with potential introduction of the tablet in Q1 2020. We also continue to evaluate the Phase 1 dose escalation data, including pharmacokinetic and tolerability data, as we target to advance IDE196 into the potentially registration-enabling study for MUM," said Julie Hambleton, M.D., Chief Medical Officer and Senior Vice President at IDEAYA Biosciences.
Key updates include:
Initiated 13-week GLP-compliant toxicology studies in 2 species in November 2019, in support of registration-enabling FDA requirement to submit study results prior to enrollment of more than approximately 50 patients in the investigational arm of the clinical trial that will support a marketing application
Pharmacokinetic Phase 1 clinical sub-study with immediate release tablet formulation of IDE196 scheduled to initiate in January 2020, in support of potential introduction of the tablet in the Phase 2 clinical trial in Q1 2020
Targeting initiation of Phase 2 single-arm potentially registration-enabling clinical trial in MUM in Q1 2020, which we anticipate may coincide with introduction of tablet formulation
Targeting initiation of combination clinical trial of IDE196 plus a MEK inhibitor in H1 2020, accelerated from earlier guidance. Preclinical evaluation of potential additional combinations ongoing
Total of 40 patients enrolled in the Phase 1 portion of the Phase 1/2 GNAQ/11 basket trial as of as of December 6, 2019, including 38 MUM patients, for which dose escalation is complete, and 2 non-MUM patients, for which enrollment is ongoing
Launching the IDEAYA Genomics Profiling Initiative (IDEAYA GPI). IDEAYA GPI is a company initiative leveraging various Next Generation Sequencing (NGS) platforms, including in partnership, to identify patients having tumors with specific mutations, such as tumors with activating GNAQ/11 mutations for potential enrollment in our IDE196 basket trial
On track to present interim clinical data from the GNAQ/11 Phase 1/2 monotherapy basket trial in Q2/Q3 2020
"We are excited for the opportunity to initiate the single-arm Phase 2 monotherapy expansion, which is potentially registration-enabling for MUM. We also look forward to advancing the clinical combination of IDE196 with MEK, as well as the GNAQ/11 basket trial to evaluate the clinical activity of IDE196 in non-MUM patients, including in skin melanoma," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.