FDA fast track designation granted for talactoferrin for renal cell carcinoma

Agennix announced that talactoferrin alfa (talactoferrin) has been granted Fast Track designation by the FDA for the first-line treatment of renal cell carcinoma (RCC) in combination with sunitinib. Agennix's RCC submission included the results from a Phase 1 trial, and a multi-center, single arm Phase 2 trial of talactoferrin in 44 patients with clear cell RCC who had failed standard therapy. Patients receiving oral talactoferrin in this Phase 2 trial had a median progression-free survival of 6.4 months, median overall survival of 21.1 months, and a one-year survival rate of 77%.

Talactoferrin is a novel targeted dendritic cell recruiter and activator (DCRA). Orally administered, Talactoferrin induces the recruitment of immature dendritic cells to the gut associated lymphoid tissue (GALT) and promotes the maturation of dendritic cells that have captured tumor antigens. Following maturation, these dendritic cells activate Natural Killer (NK) and Natural Killer T-cells (NK-T) of the innate immune pathway and CD8+ lymphocytes of the adaptive immune pathway.

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