TuHURA Biosciences (HURA) announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for TBS-2025, a VISTA-inhibiting monoclonal antibody being developed for molecularly defined subsets of acute myeloid leukemia (AML) and other blood-related cancers.
The FDA's "Study May Proceed" notice allows TuHURA to evaluate TBS-2025 in a Phase 1b study in patients with relapsed/refractory (r/r) mutNPM1 AML who have failed to respond to or relapsed following menin inhibitor therapy.
TBS-2025 will initially be evaluated as a monotherapy at different dose levels to assess safety and potential efficacy. Following review of safety data with the FDA, the company expects to advance the study to dose optimization to identify a safe and biologically effective dose.
TBS-2025 Development
TBS-2025 is designed to inhibit VISTA, an immune checkpoint expressed on resting T cells and highly expressed on myeloid cells, including myeloid-derived suppressor cells (MDSCs).
Scientific evidence indicates that mutNPM1 can drive VISTA expression on leukemic blasts, potentially contributing to immune evasion and poor responses to current therapies, including m...