On March 18, 2020 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, reported an update for IDE196, a Protein Kinase C (PKC) inhibitor, in 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, MAR 18, 2020, View Source [SID1234555685]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
IDEAYA is pursuing both a monotherapy and combination approach for IDE196 in Metastatic Uveal Melanoma and GNAQ/GNA11 hotspot mutation solid tumors, including Cutaneous Melanoma and Colorectal Cancer. The company selected a Phase 2 monotherapy dose of 400mg BID (with one-week 200mg BID run-in) and achieved first-patient-in (FPI) for the GNAQ/GNA11 non-MUM basket trial. IDEAYA also announced plans to evaluate the clinical combination of IDE196 and binimetinib, a MEK inhibitor. IDEAYA anticipates initiating this clinical combination in mid-2020 as part of its ongoing Phase 1/2 clinical trial.
Key IDE196 program updates as of March 15, 2020 include:
53 patients enrolled in Phase 1/2 monotherapy study, including 49 in MUM and 4 in Cutaneous Melanoma, from earlier-reported 40 patients in December 2019
Selected 400mg BID (with one-week 200 mg BID run-in) as Phase 2 monotherapy dose; observed approximately 44% higher average steady state exposure of free IDE196 (AUCfree) and approximately 40% higher trough concentration of IDE196 (Cmin) at the higher 400 mg BID run-in dose relative to the 300 mg BID dose
Initiated Phase 2 monotherapy expansion for GNAQ/GNA11 non-MUM basket trial
Phase 1 sub-study evaluation of pharmacokinetic profile for tablet formulation demonstrates targeted equivalence of pharmacokinetic properties with powder-in-capsule (PIC) formulation; 11 MUM patients dosed with the tablet formulation
Targeting initiation of IDE196 and binimetinib combination clinical trial in mid-2020
Interim data from IDE196 monotherapy Phase 1/2 clinical study targeted for second half of 2020
Design and initiation of potential registration-enabling study in MUM will be evaluated based on results of the ongoing Phase 1/2 monotherapy arm and the IDE196 and binimetinib combination arm of the clinical trial, at which time we will provide guidance on potential NDA timing
Cash currently anticipated to be sufficient to fund planned operations into end of 2021 to early 2022, which is an extension from the earlier guided third quarter 2021
"We continue to see robust enrollment of MUM patients in our Phase 1/2 monotherapy study and look forward to providing the interim data update in the second half of 2020," said Julie Hambleton, M.D., Chief Medical Officer and Senior Vice President at IDEAYA Biosciences. "We have made significant progress in the IDE196 clinical program, including selecting the Phase 2 monotherapy dose, initiating Phase 2 monotherapy expansion for the basket trial for non-MUM patients, and introducing the tablet formulation. In addition, we plan to evaluate a combination strategy targeting multiple nodes of the MAP-Kinase pathway, which we believe may inform the optimal registrational path for MUM."