The FDA has granted orphan drug designation to XNK Therapeutics’ autologous cell therapy CellProtect for the treatment of multiple myeloma (MM). CellProtect is produced through ex vivo expansion and activation of natural killer cells from peripheral blood of patients with cancer.
In the phase I/II ACP-001 trial at the Karolinska University Hospital in Stockholm, Sweden, researchers evaluated CellProtect as a consolidation treatment following hematopoietic cell transplantation in patients with newly diagnosed MM. The median progression-free survival among participants was 34 months, with an overall survival rate of 100% after a median follow-up of 60 months. These results were presented as part of EHA25 Virtual, the 25th Annual Congress of the European Hematology Association.
Prior to the FDA’s decision, CellProtect had been granted orphan drug designation in Europe.
Source: XNK Therapeutics press release, November 4, 2020.