Breakthrough Technology Empowers NK Cell Therapy for Acute
Myeloid Leukemia
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/
Contact: Martin Hyun
808-354-9669
376912@email4pr.com
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SOURCE Ingenium Therapeutics