IDEAYA Biosciences (NASDAQ:IDYA) announces that, based on FDA feedback, it will initiate a 60-subject Phase 2 single-arm clinical trial evaluating lead candidate IDE196 as monotherapy for the treatment of metastatic uveal melanoma (MUM) this quarter.
The primary endpoint will be overall response rate (ORR).
If successful, it may support a U.S. marketing application under accelerated review status.
IDE196 is a protein kinase C inhibitor in-licensed from Novartis for GNAQ- or GNA11-mutation-positive solid tumors.
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