Kura Oncology(US:KURA)2023-05-18 15:25Ziftomenib (Menin Inhibitor) - Ziftomenib targets MENIN-KMT2A/MLL in acute leukemias [4] - Phase 1/2 clinical trial KOMET-001 is evaluating Ziftomenib in patients with NPM1 mutations (NPM1-m) and KMT2A rearrangements (KMT2A-r) [10] - In Phase 1a + 1b trials, the CR rate for NPM1-m patients at 600 mg was 30% (6/20), and the ORR was 40% (8/20) [14] - Ziftomenib monotherapy shows optimal clinical activity at the 600 mg daily dose [136] - Kura plans to initiate a Phase 1 combination trial of Ziftomenib (KOMET-007) with standards of care in patients with NPM1-mutant or KMT2A-rearranged AML [50] Tipifarnib & KO-2806 (Farnesyl Transferase Inhibitors) - Kura is developing next-generation FTI KO-2806 with improved potency, pharmacokinetic and physicochemical properties [77, 78] - The FDA cleared the IND application for KO-2806, and Kura is on track to initiate a Phase 1 study in 2H 2023 [94] - Kura is conducting a Phase 1/2 combination trial (KURRENT-HN) of Tipifarnib with Alpelisib for HNSCC patients with PIK3CA mutation and/or amplification [56] - Preclinical data supports the potential of Tipifarnib to prevent emergence of resistance to targeted therapies [105] Financial Highlights - Kura had $406 million in cash as of March 31, 2023 [96]