NKGen Biotech Presents Additional Phase 1 Clinical Trial Data in Alzheimer’s Disease at the Tau2024 Global Conference

SNK01 autologous NK cell therapy demonstrated a positive effect on cerebral spinal fluid (“CSF”) and plasma Tau proteins in Alzheimer’s patients.

The additional Phase 1 SNK01 trial data suggest clinical activity regarding cognitive function in patients with advanced Alzheimer’s disease in addition to previously disclosed positive effects on amyloid protein and neuroinflammation biomarkers.

SANTA ANA, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK Natural Killer (“NK”) cell therapeutics, today presented additional Phase 1 clinical trial data on the use of its investigational autologous NK cell therapy, SNK01, to treat patients with Alzheimer’s disease (“AD”) at the Tau2024 Global Conference in Washington, D.C.

The presentation contained data from an abstract entitled, “Beneficial Effect on CSF and Plasma Tau Proteins and Cognitive Function in Alzheimer’s Disease Subjects Treated with Expanded Non-Genetically Modified Autologous Natural Killer Cells (SNK01).” In this Phase 1 study, SNK01 was administered intravenously (“IV”) every three weeks for a total of four treatments using a 3+3 dose escalation design (1, 2, and 4 x 10⁹ cells) in patients with either mild, moderate, or severe AD (Median MMSE of 14). Cognitive assessments and CSF/plasma pTau217 and pTau181 analyses were performed at baseline and at 1 and 12 weeks after the final dose. The primary endpoint was safety and secondary endpoints included changes in cognitive assessments and biomarker levels.

“The data presented today demonstrate additional beneficial effects of SNK01 for the treatment of Alzheimer’s disease,” commented Paul Y. Song, M.D., CEO of NKGen. “The data from this Phase 1 trial further validates the ability of SNK01 to improve pTau, amyloid Aβ42/40, and alpha-synuclein biomarkers as well as improving cognitive scores, consistent with what we have previously observed. While the results were positive, the Phase 1 trial was a dose-escalation trial that only administered four total doses over 11 weeks. However, our Phase 1/2a SNK01 trial in moderate Alzheimer’s patients, initiated in December 2023, utilizes a 50% higher dose than the highest dose administered in the prior Phase 1, and prolonged dosing regimen for over one year in which we expect to show an even greater clinical benefit. We are excited to continue our research with the goal of offering our NK cell therapy to patients with Alzheimer’s disease who are in need of disease modifying treatments.”