XNK gets orphan drug nod from FDA

By The Science Advisory Board staff writers

November 4, 2020 -- XNK Therapeutics has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its natural killer (NK) cell-based investigational drug candidate to treat multiple myeloma.

This designation, which already was received in the European Union, allows XNK to advance clinical development of the drug. The company completed its first-in-human phase I/II clinical trial in multiple myeloma at the Karolinska University Hospital in Stockholm, Sweden, which showed the drug had a very good safety profile and promising efficacy data.

XNK plans to move ahead with clinical development of the drug candidate for multiple myeloma in Europe. The NK cell-based therapy was designed using XNK's closed manufacturing system.

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