TuHURA Biosciences, Inc. (NASDAQ: HURA) is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. TuHURA’s lead innate immune response agonist candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda®️ (pembrolizumab) in first line treatment for advanced or metastatic Merkel Cell Carcinoma.
Additionally, TuHURA is developing TBS 2025, a VISTA-blocking immunotherapy. VISTA (V-domain Ig suppressor of T cell activation) is an immune checkpoint highly expressed on myeloid cells. VISTA is a strong driver of immunosuppression in the tumor microenvironment (TME). VISTA expression is found on infiltrating immune cells, with the highest levels on myeloid lineage cells, including MDSCs. It suppresses T cell function, and high levels of VISTA expression in the human TME have been correlated in most studies with decreased overall survival (OS). The company plans to initiate a Phase 2 study of TBS 2025 in NMP1-mutated AML in combination with a menin inhibitor in the 2H of 2025.
In addition to its innate immune response agonist candidates, TuHURA is leveraging its Delta receptor technology to develop first-in-class bi-specific ADCs, and PDCs targeting Myeloid Derived Suppressor Cells to inhibit their immune suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.