SAN DIEGO - Kura Oncology, Inc. (NASDAQ: NASDAQ:KURA), a clinical-stage biopharmaceutical company, has announced the initiation of a Phase 1 clinical trial, KOMET-008, involving its investigational drug ziftomenib.
The trial is evaluating ziftomenib in combination with other treatments for acute myeloid leukemia (AML) patients with specific genetic mutations.
The study will assess the safety, tolerability, pharmacokinetics, and clinical activity of ziftomenib when used with gilteritinib, FLAG-IDA, or LDAC in patients with relapsed or refractory NPM1-mutant or KMT2A-rearranged AML. The first patient has been dosed in the trial, marking a significant step in the development of this potential new therapy.
Dr. Stephen Dale, Chief Medical Officer of Kura Oncology, highlighted the poor prognosis for AML patients with NPM1-mutant and co-occurring FLT3 mutations, emphasizing the need for an effective treatment. He expressed hope that the combination of ziftomenib and gilteritinib, both oral medications, could offer an attractive treatment option for these patients.
Ziftomenib, a menin inhibitor, targets a protein-protein interaction believed to be a driver of AML with certain genetic alterations. The drug has previously shown promising results in monotherapy and has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML.
Kura Oncology is also conducting additional studies to evaluate ziftomenib in combination with standard treatments for various AML patient populations. Preliminary data from a related study, KOMET-007, showed positive results from 20 patients as of January 30, 2024.
AML is a challenging disease with a high unmet need for effective treatments, as current options have limited success, especially in relapsed or refractory cases. The menin pathway is considered crucial in the disease's progression, with NPM1 mutations present in approximately 30% of AML cases and KMT2A rearrangements in about 5-10%.
This news is based on a press release statement from Kura Oncology. The company continues to explore precision medicines for cancer treatment, with a pipeline of small molecule drug candidates targeting various cancer signaling pathways. The ongoing trials and studies are part of Kura's commitment to addressing the unmet needs of AML patients.
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