NKGen Biotech Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for SNK01 natural killer (NK) cell therapy for treatment of moderate Alzheimer's Disease (AD). SNK01 is an autologous, non-genetically modified NK cell product that has enhanced cytotoxicity and activating receptor expression. This approved trial of 30 patients with moderate AD will look to commence before the end of this year and the first interim data is expected in early third quarter 2024.

NKGen?s SNK01 program continues to show positive progress in Alzheimer?s Disease, as demonstrated by results reported in recent poster presentations in July and October 2023 at AAIC and WCN, respectively. The Phase I, 3 + 3 dose-escalation trial, data on the use of SNK01 to treat patients with Alzheimer?s Disease demonstrated that SNK01 was well tolerated and appeared to cross the blood-brain barrier to help reduce proteins and neuroinflammation in a dose-dependent manner without any related serious adverse effects observed. No dose-limiting toxicities were reported, while positive changes in cognitive function and cerebrospinal fluid biomarkers were observed.