On December 13, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported the presentation of new preclinical data for KO-539, the Company’s oral, potent and selective menin inhibitor, and its potential for synergistic activity in combination with venetoclax, a current standard of care in the treatment of patients with acute myeloid leukemia (AML) (Press release, Kura Oncology, DEC 13, 2021, View Source [SID1234596929]).
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The new findings, generated through a research collaboration with Dr. Kapil Bhalla at the MD Anderson Cancer Center, are being presented during a poster session today at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual meeting in Atlanta. A copy of the poster is available on the Company’s website at www.kuraoncology.com.
KO-539 has previously been shown to disrupt the menin-KMT2A/MLL protein-protein interaction, inducing differentiation and potent anti-leukemic activity in genetically defined preclinical models of AML. The new preclinical data confirm that treatment with KO-539 drives dose-dependent induction of growth inhibition, differentiation and loss of viability of AML cells with KMT2A rearrangements or NPM1 mutations, while also reducing key protein levels such as MEIS1, FLT3 and BCL2 and menin itself.
In addition, the new findings show that co-treatment with KO-539 and the BCL2 inhibitor venetoclax induces synergistic activity in patient-derived AML cells expressing KMT2A rearrangements or NPM1 mutations, with or without mutant FLT3 expression, and prolongs survival in an aggressive disseminated model of KMT2A-rearranged, FLT3-mutant AML.
"Although the combination of venetoclax and azacitidine has ushered in a new standard of care, there remains a significant unmet need for patients with AML," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "These important findings highlight the molecular mechanisms of anti-leukemic activity for KO-539, suggest the potential for synergistic activity in combination, and support our development strategy to combine KO-539 with venetoclax in patients with AML."
About KO-539
KO-539 is a novel, once-daily, oral investigational drug candidate targeting the menin-KMT2A/MLL protein-protein interaction for treatment of genetically defined AML patients with high unmet need. KO-539 is currently in a Phase 1b clinical trial (KOMET-001) for patients with relapsed/refractory AML, including patients with NPM1 mutations or KMT2A rearrangements. In July 2019, the U.S. Food and Drug Administration granted Orphan Drug Designation to KO-539 for the treatment of AML.