TuHURA Biosciences said the FDA granted orphan drug designation to IFx-2.0 for stage IIB to stage IV cutaneous melanoma based on Phase 1 data. The company said its Phase 3 IFx-2.0 study in first-line Merkel cell carcinoma continues to enroll.
TuHURA Biosciences filed an FDA IND for TBS-2025, a VISTA-targeting antibody, plus a menin inhibitor in mutNPM1 r/r AML. Phase 2 targets early Q2 2026 with preliminary Stage 1 results in Q3 2026.
TuHURA Biosciences filed an IND application with the FDA for TBS-2025, a VISTA inhibiting antibody, to be studied in combination with a menin inhibitor for treating mutNPM1 relapsed/refractory Acute Myeloid Leukemia.
