Kura Oncology, Inc. (NASDAQ:KURA) is up ~16% in pre-market trading after announcing encouraging preliminary clinical data for KO-539 in a Phase 1/2A clinical trial for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML).
The data presented during the 62nd American Society of Hematology (NYSE:ASH) Annual Meeting and Exposition were the first-in-human data generated by KO-539, a novel, once-daily, oral menin inhibitor for the treatment of genetically defined AML patients with a high unmet need.
The enrollment is ongoing in the dose escalation of Phase 1/2A clinical trial to determine the safety, tolerability and recommended Phase 2 dose of KO-539, and an expansion phase in specific genetic subgroups is expected in the first quarter of 2021.
On the safety front, there have been no drug discontinuations due to treatment-related adverse events, and the continuous daily dosing of KO-539 has been well tolerated with a manageable safety profile to date.
“The preliminary clinical data for KO-539 suggest it has the potential to be effective for multiple genetically defined AML subgroups of high unmet need” said Eunice Wang, M.D., Chief of the Leukemia Service at Roswell Park Comprehensive Cancer Center and principal investigator of the trial.
KO-539 has already won the Orphan Drug Designation from the FDA.
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