TuHURA Biosciences, formed by CohBar and Morphogenesis, a UF startup, announced that the U.S Food and Drug Administration’s (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to IFx-2.0 for the treatment of stage IIB to stage IV cutaneous melanoma.
The ODD designation was based on data from the Company’s previously completed Phase 1 study of IFx-2.0, results of which were published in the journal Molecular Therapeutics and entitled: “First-in-Human Stage II/IV Melanoma Clinical Trial of Immune Priming Agent IFx-Hu2.0,” authored by Dr. Joseph Markowitz, Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute. The study demonstrated IFx-Hu2.0 to be safe with no serious dose limiting toxicities in addition to demonstrating that patients refractory to checkpoint inhibitor therapy (anti-PD1) experienced clinical benefit upon subsequent anti-PD1 based treatment.
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