NKMAX, a Korean natural killer (NK) cell-based immunotherapy company, announced on Wednesday that its U.S. subsidiary, NKGen Biotech, has received U.S. FDA approval to initiate phase 1/2a clinical trials for SNK01, an NK cell therapy for Alzheimer’s disease in the U.S.

Building on the results of the phase 1 clinical trial of SNK01 conducted in Mexico, the FDA has granted its approval for NKGen Biotech to continue the trial in the U.S., NKMAX said.

Notably, the Mexican phase 1 clinical trial, which took place in August 2020, administered a dosage of “4 billion SNK01s” to 10 patients. In the upcoming U.S. clinical trial, this dosage will be increased to a maximum of "6 billion SNK01s" to assess both safety and effectiveness, NKMAX said.

While the earlier clinical trial in Mexico targeted mild Alzheimer's patients, the U.S. trial is designed for individuals with moderate Alzheimer's disease. For 49 weeks, SNK01 will be administered a total of 17 times to 36 patients in the U.S.

According to NKMAX, SNK01 goes beyond targeting abnormal protein aggregates like amyloid beta (Aβ) and tau, which are commonly addressed by existing antibody treatments. SNK01 enhances the overall immune environment within the brain by reducing neuroinflammation.

Paul Song, CEO of NKGen Biotech, said, “While most current therapeutics remain focused on the mild cognitive impairment or mild dementia population, the FDA has allowed us to focus our efforts on a more advanced population for which there is currently no approved disease-modifying therapy.” 

“We believe that the FDA’s clearance validates the potential and merit of our approach.”

NKMAX is poised to unveil the final data from the phase 1 clinical trials of Alzheimer's cell therapy, conducted in Mexico, at the Clinical Trials on Alzheimer's Disease (CTAD) event being held from Tuesday to Friday this week in Boston, the U.S.