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Kura Oncology Doses First Patient in Phase 1b Expansion Cohorts with Menin Inhibitor KO-539
– Phase 1b expansion cohorts designed to enable refinement of recommended Phase 2 dose – – At least 12 patients to be enrolled in each of two Phase 1b
About this update from Kura Oncology, Inc.
[{"type":"text","content":"– Phase 1b expansion cohorts designed to enable refinement of recommended Phase 2 dose – – At least 12 patients to be enrolled in each of two Phase 1b expansion cohorts: a 200 mg dose cohort and a 600 mg dose cohort – – Each cohort to be genetically enriched with NPM1-mutant and KMT2A-rearranged relapsed/refractory AML patients – – Company anticipates that patient data from the recommended Phase 2 dose cohort will be included as part of the registration-directed portion of the trial – SAN DIEGO, June 24, 2021 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that the first patient has been dosed in the Phase 1b portion of KOMET-001, a Phase 1/2 clinical trial of the Company’s oral, potent and selective menin inhibitor, KO-539, in patients with relapsed or refractory acute myeloid leukemia (AML). KO-539 demonstrated a wide therapeutic window in the Phase 1a dose-escalation portion of KOMET-001, with promising single-agent activity from 50 mg to 800 mg in an all-comer population of patients with relapsed or refractory AML, including patients with NPM1 mutations and KMT2A rearrangements. The Phase 1b portion of the study is designed to determine the lowest dose of KO-539 that provides maximum biologic and clinical effect in two expansion cohorts – a low dose (200 mg) and a high dose (600 mg) – each enriched with NPM1-mutant and KMT2A-rearranged relapsed/refractory AML patients. Both doses have demonstrated preliminary evidence of biologic and clinical activity and were determined to be safe and well tolerated in the Phase 1a portion of the study. Kura expects to enroll at least 12 patients in each of the Phase 1b expansion cohorts and assess those patients for safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy in order to determine the recommended Phase 2 dose. In addition, the Phase 1b gives the Company flexibility to enroll up to 18 additional patients per cohort, as appropriate. Kura believes that data from patients enrolled in the cohort selected as the recommended Phase 2 dose can be included as part of the registration-directed portion of the KOMET-001 trial. “We believe KO-539 has the potential to be both a first-in-class and a best-in-class menin inhibi...