Artiva Biotherapeutics Receives FDA Fast Track Designation for AlloNK® in Lupus Nephritis
Artiva Biotherapeutics, Inc. , a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Artiva’s lead program AlloNK® (also known as AB-101) for the treatment of lupus nephritis (LN) in combination with rituximab or obinutuzumab.
- Artiva Biotherapeutics, Inc. , a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Artiva’s lead program AlloNK® (also known as AB-101) for the treatment of lupus nephritis (LN) in combination with rituximab or obinutuzumab.
- Artiva previously received FDA clearance of an Investigational New Drug (IND) application for AlloNK in combination with rituximab in LN, marking the first IND clearance of an allogeneic, off-the-shelf NK cell therapy in autoimmune disease.
- AlloNK is a non-genetically modified, allogeneic, cryopreserved NK cell therapy candidate that enhances the activity of B-cell-targeting monoclonal antibodies to drive B-cell depletion.
- “The FDA Fast Track designation gives us an opportunity to accelerate our efforts to bring our AlloNK cell therapy to autoimmunity patients,” said Fred Aslan, M.D., Chief Executive Officer of Artiva.