October 12, 2020 -- Glycostem Therapeutics has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for its off-the-shelf natural killer (NK) cell product, oNKord, for the treatment of multiple myeloma.
oNKord is a first-generation off-the-shelf NK cellular immunotherapy product. In the next months, acute myeloid leukemia patients will receive the treatment as a part of a phase I/IIa clinical trial. A phase II trial for multiple myeloma patients is expected to begin in 2021.
Glycostem products are a safe alternative to chimeric antigen receptor (CAR) T-cell therapies that harness the power of stem cell-derived NK cells, according to the firm. oNKord products are manufactured from allogenic raw material, produced in a closed system in the company's facility in the Netherlands. Production includes ex vivo generation of natural killer cells.
oNKord has been successfully evaluated in a phase I clinical trial in acute myeloid leukemia patients, which established safety and clinical activity.
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