Artiva Biotherapeutics Receives FDA Fast Track Designation for AlloNK in Lupus Nephritis

On February 22, 2024, Artiva announced that the FDA has granted Fast Track designation to Artiva’s AlloNK (AB-101) for the treatment of lupus nephritis in combination with rituximab or obinutuzumab. AlloNK is an allogeneic, off-the shelf, NK cell therapy that is not genetically modified and designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) of antibodies or NK cell engagers. Fred Aslan, M.D., Chief Executive Officer of Artiva stated “The FDA Fast Track designation gives us an opportunity to accelerate our efforts to bring our AlloNK cell therapy to autoimmunity patients.”

This comes at the heels of the FDA’s recent approval of the first cellular therapy for treatment of unresectable or metastatic melanoma and of the first cell-based therapies for treatment of sickle cell disease.