NKGen Biotech Receives Clearance For SNK01 NK Cell Therapy Clinical Trial From Health Canada

(RTTNews) - Biotechnology company NKGen Biotech Inc. (NKGN) announced Wednesday 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 cell therapy for the treatment of patients with moderate Alzheimer's Disease.

SNK01 program continues to show positive progress with the FDA IND clearance in October 2023, and now the CTA clearance by Health Canada. The U.S. Phase 1/2a trial of SNK01 in moderate Alzheimer's disease patients officially opened with first patient enrolled in December 2023.

This approved trial of approximately 36 patients with moderate AD is expected to commence in December 2023 with the first interim data expected in the third quarter of 2024.

Phase 1 is an open label safety evaluation to determine the maximum tolerated dose and/or recommended Phase 2 dose of SNK01.

Phase 2 is a randomized, placebo controlled, multicenter trial evaluating the safety and efficacy of SNK01 in moderate AD patients.