NKMAX Receives US FDA Approval for Alzheimer's Clinical Trial... "First Cell Therapy Company"
NKMAX becomes the first cell therapy company to conduct Alzheimer's clinical trials in the United States.
NKMAX announced on the 25th that its subsidiary, NKGen Biotech, received approval from the U.S. Food and Drug Administration (FDA) for the IND (Investigational New Drug) application for SNK01 (autologous NK cell therapy) Alzheimer's clinical trial Phase 1/2a.
This clinical trial will proceed in the U.S. as a Phase 1/2a study, following the FDA's recognition of the Phase 1 Alzheimer's clinical trial data conducted in Mexico by NKMAX. In the Mexico trial, up to 4 billion SNK01 cells were administered, whereas in this U.S. trial, up to 6 billion SNK01 cells will be administered to explore the safety and efficacy of the dosage.
Notably, while the previous Mexico trial included patients with mild symptoms, this trial targets only patients with moderate Alzheimer's disease. The study will be conducted at four centers in the U.S., administering SNK01 a total of 17 times over 49 weeks to 36 patients with moderate Alzheimer's disease.
SNK01 not only helps remove abnormal protein aggregates (plaques) such as amyloid-beta (Aβ) and tau, which current antibody therapies focus on, but also reduces neuroinflammation, thereby improving the overall immune environment in the brain.
Paul Song, CEO of NKGen Biotech, stated, “Most treatments focus on mild Alzheimer's disease, and there are currently no treatment options for patients with advanced stages of the disease. The FDA has even suggested extending the dosing period to prioritize treatment for moderate Alzheimer's disease, which shows the potential of SNK01 in this trial.”
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Meanwhile, NKMAX will present the final data from the Mexico Phase 1 Alzheimer's clinical trial, including the high-dose group receiving 4 billion SNK01 cells, at the upcoming Clinical Trials on Alzheimer's Disease (CTAD) conference this month.
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