Core Insights - TuHURA Biosciences, Inc. has received Orphan Drug Designation from the FDA for its product IFx-2.0, aimed at treating stage IIB to stage IV cutaneous melanoma [1][3] - The designation is based on positive results from a Phase 1 study, which indicated that IFx-Hu2.0 is safe and provides clinical benefits to patients who are refractory to checkpoint inhibitor therapy [2] - The company is currently focused on completing enrollment for a Phase 3 study of IFx-2.0 in combination with Keytruda® for advanced or metastatic Merkel Cell Carcinoma [3] Company Overview - TuHURA Biosciences is a Phase 3 immuno-oncology company that develops novel therapeutics to address resistance to cancer immunotherapy [4] - The lead product, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors and is being tested in a randomized Phase 3 trial [5] - The company has also acquired TBS-2025, which is moving into Phase 2 development for mutNPM1 r/r AML, and is developing bi-specific antibody drug conjugates targeting immune-suppressing cells in the tumor microenvironment [6]
TuHURA Biosciences received FDA Orphan Drug Designation for IFx-2.0 for the Treatment of Stage IIB to Stage IV Cutaneous Melanoma