TuHURA Biosciences wins FDA IND clearance for TBS-2025 in mutNPM1 AML study
HURA•FDA clears IND for TBS-2025 study
TuHURA Biosciences received FDA IND clearance for TBS-2025, a VISTA-inhibiting antibody, in molecularly defined subsets of AML.
“Study may proceed” notice enables a Phase 1b trial in relapsed or refractory mutNPM1 AML following menin inhibitor failure.
The trial will assess monotherapy safety, dose escalation, then dose optimization to select a biologically effective dose.
The company may discuss an accelerated approval pathway if dose-optimization data show encouraging response rates.
