NKMAX Completes First Patient Dosing in US Alzheimer's Clinical Trial

NKMax announced on the 2nd that its affiliate NKGen Biotech has completed the first patient dosing in the SNK01 (autologous NK cell therapy) Alzheimer's clinical Phase 1/2a trial being conducted in the United States.

In October of last year, NKGen Biotech received approval from the U.S. Food and Drug Administration (FDA) for the SNK01 Alzheimer's clinical Phase 1/2a trial plan (IND). This clinical trial plans to explore the safety and efficacy by administering up to 6 billion SNK01 cells a total of 17 times to 36 patients with moderate Alzheimer's disease.

Previously, NKGen Biotech successfully completed the final results of the Mexico Alzheimer's Phase 1 clinical trial, which were presented last year at the Clinical Trials on Alzheimer's Disease (CTAD) annual meeting. Based on the results of the Mexico Alzheimer's Phase 1 trial, the U.S. FDA allowed the Phase 1/2a trial to proceed without preclinical studies. The first patient with moderate Alzheimer's disease to receive dosing in this trial was administered up to 6 billion SNK01 cells, which is 50% more than the maximum dose (4 billion cells) used in the previous Mexico Phase 1 trial.

Paul Song, CEO of NKGen Biotech, said, “We are pleased that SNK01 has been administered to the first patient in the U.S. Alzheimer's Phase 1/2a trial,” adding, “Currently developed treatments are used for mild Alzheimer's patients, so we plan to focus on moderate patients who have no treatment options.”

He continued, “This Phase 1/2a trial administers 6 billion cells, which is 50% more than the maximum dose in the previous Mexico Alzheimer's Phase 1 trial, to patients with moderate Alzheimer's disease,” emphasizing, “Since a total of 17 doses of up to 6 billion high-dose cells will be administered, we expect positive outcomes for Alzheimer's disease through SNK01's long-term immune regulatory function in the brain.”

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