TuHURA receives FDA clearance for leukemia drug trial

Tampa, Florida - The FDA has granted clearance for TuHURA Biosciences' investigational new drug application (IND) for TBS-2025, an antibody targeting specific subtypes of Acute Myeloid Leukemia and other blood-related cancers. This clearance enables TuHURA to initiate a Phase 1b clinical trial to assess the safety and potential efficacy of TBS-2025 monotherapy at varying doses in patients with relapsed/refractory mutNPM1 acute myeloid leukemia (AML) who have either failed or relapsed after treatment with menin inhibitor therapy.

Patients with relapsed/refractory mutNPM1 AML have no currently approved or effective treatment options. If TBS-2025 demonstrates promising response rates during the dose optimization stage, TuHURA will seek the FDA's approval to expand the trial with the possibility of accelerated approval. Dr. James Bianco, TuHURA's President and CEO, emphasized this milestone, stating that the company is the sole entity to advance a VISTA-inhibiting monoclonal antibody (mAb) through the FDA's IND process into a Phase 1b study in this specific AML population.

TBS-2025 is a VISTA-inhibiting monoclonal antibody, where VISTA is a checkpoint protein predominantly expressed on quiescent T cells and myeloid cells. Research indicates that mutNPM1 drives the overexpression of VISTA on leukemic blasts. TuHURA is a Phase 3 immuno-oncology company developing treatments aimed at overcoming resistance to cancer immunotherapy, currently in the early stages of a Phase 3 trial for their lead product, IFx-2.0, in combination with pembrolizumab for advanced or metastatic Merkel cell carcinoma.