NKGen Biotech Inc. presented a poster with Phase I trial data on the use of its investigational NK cell therapy, SNK01, to treat patients with Alzheimer's disease (AD) at the Clinical Trials on Alzheimer's Disease (CTAD) Annual Meeting in Boston, MA. The poster, entitled "Treatment of Alzheimer's Disease Subjects With Expanded Non-genetically Modified Natural Killer Cells (SNK01) With Enhanced Activity -- Final Report of a Phase I Dose Escalation Study", provided results from a single center, open label, Phase I study evaluating the safety, tolerability, and exploratory efficacy of SNK01 in patients with AD. SNK01 was given via intravenously (IV) every three weeks for a total of four treatments using a 3 + 3 dose escalation design (1, 2 & 4 x10(9) cells) in patients with mild, moderate or advanced AD disease confirmed by MRI and PET scans.

The severity of AD was based on the baseline Clinical Dementia Rating-Sum of Boxes, or CDR-SB score. Cognitive Assessments (CDR-SB, Mini-Mental State Examination (MMSE), The Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog]), composite ADCOMS score, and CSF biomarker analyses were performed at baseline and at one week and twelve weeks after the final dose (Weeks 11 and 22, respectively). The primary endpoint was safety and secondary endpoints included changes in cognitive assessments and biomarker levels.

Highlights from the Poster Presentation: Apatienents (n=10) from the first three cohorts in the dose escalion were analyzed (5 patients had mild A AD, 3 patients had moderate AD, and 2 patients had severe AD) with a median baseline CDR-SB score of 9 (4--18). NK cells were activated and expanded for all patients in the trial. No treatment related adverse events were observed.

One week after final dose (Week 11): 30% of patients showed clinical improvement on the composite ADCOMS score compared to baseline; 60% of patients showed a stable ADCOMS score compared to baseline; 50--70% of patients were stable or improved on the CDR-SB, ADAS-Cog and/or MMSE scores; and, One patient's score showed a switch from a moderate classification on the ADCOMS to a mild classification. Twelve weeks after final dose (Week 22): 44--89% of patients remained stable or improved in all cognitive scores compared to Week 11; and, 50% of the patients with stable ADCOMS scores at Week 11 remained stable. Based on the CSF biomarker data, SNK01 given via IV appears to cross the blood-brain barrier to reduce CSF pTau181 levels and neuroinflammation, as measured by GFAP; this effect appears to be persistent at Week 22.