The IND is aligned with guidance previously provided by the U.S. Food and Drug Administration (FDA) on the development pathway for both monotherapy and combination with menin inhibitors for Acute Myeloid Leukemia (AML) The FDA noted that the requested meeting would not be necessary and that it will instead provide written responses to questions and information related to the Company's proposed Phase 1b/2 development plan for TBS-2025 in AML The Company is targeting initiation of the Phase 1b/2 study in the second half of 2026 TAMPA, Fla., June 15, 2026 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ: HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the study of its TBS-2025 VISTA inhibiting antibody for the treatment of molecularly defined subsets of AML and other blood related cancers.
