Gengluecel Receives Orphan Drug Designation for AML

By Blood Cancers Today Staff Writers - Last Updated: August 23, 2024

The US Food and Drug Administration has granted Orphan Drug Designation to IGNK001 (gengluecel) for the treatment of acute myeloid leukemia (AML), according to a press release from Ingenium Therapeutics, the developer of the drug.

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IGNK001, an investigational allogeneic natural killer cell therapy, has already been approved by the Korean Ministry of Food and Drug Safety for phase II clinical trials.

The company is preparing to initiate clinical trials in the United States. These studies will include 80 patients and have an intended completion date of December 2027.

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