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Ingenium Therapeutics Novel NK Cell Therapy IGNK001 Receives Orphan Drug Designation From FDA – Drugs.com MedNews

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).

Ingenium’s proprietary technology enables the company to differentiate and proliferate natural killer (NK) cells with superior anti-cancer efficacy. By targeting CD3-negative immune cells, the company can acquire a large number of highly pure NK cells in a relatively short timeframe. 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. “Gengluecel has already received approval from the Korean Ministry of Food and Drug Safety for phase 2 clinical trials, and we are preparing to initiate clinical trials in the U.S. targeting 80 subjects with the goal of completing the studies by December 2027.”

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.

About Ingenium Therapeutics

Ingenium Therapeutics is a pioneering biopharmaceutical company dedicated to developing next-generation NK cell therapies. The company’s innovative technology platform enables the production of highly potent, allogeneic NK cells with enhanced anti-cancer capabilities. Ingenium is committed to advancing its lead candidate, IGNK001 (Gengluecel), through clinical development and regulatory approval to provide new treatment options for patients with acute myeloid leukemia and other hematological malignancies. For more information, go to https://ingeniumcell.co.kr/en/

SOURCE Ingenium Therapeutics

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