NKMax to perform first tests on dementia cell therapy in US

NKMax Co., South Korea's largest developer of natural killer (NK) cell therapies, will conduct its first clinical trials in the US for its candidate treatment for Alzheimer's.

The company on Wednesday said its American subsidiary NKGen Biotech received approval from the US Food and Drug Administration (FDA) to perform Phase 1/2a clinical trials for SNK01, an autologous NK cell-based therapy drug for the disease.

NKGen Biotech received FDA recognition for clinical data derived from Phase 1 trials for Alzheimer’s done in Mexico and will conduct Phase 1/2a in the US. The Mexican tests administered up to four billion units of SNK01 but those in the US will raise that ceiling to six billion to explore the safety and effectiveness of dosage.

The Mexican trials included mild cases but those in America will target moderate. Over 49 weeks, SNK01 will be administered 17 times to 36 patients with moderate Alzheimer's at four centers in the US.

“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,” NKGen Biotech CEO Paul Y. Song said. “We believe that the FDA’s clearance validates the potential and merit of our approach.”

Write to Young-Ae Lee at 0ae@hankyung.com