NKGen Biotech Inc. announced that it has received a No Objection Letter from Health Canada for its Clinical Trial Application for a Phase 1/2a study to evaluate the safety, tolerability, and exploratory efficacy of SNK01 natural killer ("NK") cell therapy for treatment of patients with moderate Alzheimer's Disease. SNK01 is an autologous, non-genetically modified NK cell product that has enhanced cytotoxicity and activating receptor expression. Phase 1 is an open label safety evaluation to determine the maximum tolerated dose and/or recommended Phase 2 dose of SNK01.

This approved trial of approximately 36 patients with moderate AD is expected to commence in December 2023 with the first interim data expected in third quarter 2024. NKGen's SNK01 program continues to show positive progress in Alzheimer's Disease, as demonstrated by the most recent results reported at the Clinical Trials on Alzheimer's Disease ("CTAD") Annual Meeting in October 2023. Data from a Phase 1, 3 + 3 dose-escalation trial of SNK01 in patients with AD, suggested that SNK01 was well tolerated, and appeared to cross the blood-brain barrier to have a positive effect on brain protein aggregates as well as on neuroinflammation without any related serious adverse effects observed.

90% of patients demonstrated improvement or maintained stable cognitive function as per Alzheimer's disease composite score (?ADCOMS?) at 11 weeks (one week after the last dose).