Ingenium Therapeutics Novel NK Cell Therapy Receives Orphan Drug Designation From FDA
DAEJEON, Korea, April 30, 2024 /PRNewswire/ -- Ingenium Therapeutics, a leading innovator in next-generation NK cell therapies, announced today that its investigational therapy IGNK001 (Gengluecel) has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML).
- DAEJEON, Korea, April 30, 2024 /PRNewswire/ -- Ingenium Therapeutics, a leading innovator in next-generation NK cell therapies, announced today that its investigational therapy IGNK001 (Gengluecel) has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML).
- This mass-produced, allogeneic NK cell therapy derived from healthy donors demonstrates potent anti-cancer effects with high purity and activity.
- "We are delighted to have received Orphan Drug Designation for IGNK001 from the FDA, recognizing the potential of our innovative NK cell therapy technology," said Ko Jin-ok, CEO of Ingenium Therapeutics.
- The Orphan Drug Designation provides Ingenium with various development incentives, including tax credits for qualified clinical trials, exemption from FDA application fees, and a potential seven-year period of market exclusivity upon regulatory approval.