NKMAX Announces Interim Results of SNK01 Alzheimer's Phase 1 Clinical Trial

NKMAX announced on the 17th that its subsidiary, NKGen Biotech, revealed the interim results of the Phase 1 clinical trial of the natural killer (NK) cell therapy ‘SNK01’ for Alzheimer's treatment at the Alzheimer's Association International Conference (AAIC 2023) held in Amsterdam, Netherlands.

Polsong, CEO of NKGen Biotech, is explaining the content of a poster presentation at the AAIC event. [Photo by NKMax]

The ongoing Phase 1 clinical trial by NKGen Biotech involves data from a total of 10 Alzheimer's patients (5 mild cases, 5 moderate to severe cases). The patients were divided into groups receiving low dose (1 billion cells), medium dose (2 billion cells), and high dose (4 billion cells) of SNK01, administered intravenously (IV) once every 3 weeks for a total of 4 doses. Cognitive assessments (Clinical Dementia Rating-Sum of Boxes (CDR-SB), Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-COG), Mini-Mental State Examination (MMSE)) were conducted 1 week and 12 weeks after the last SNK01 administration, along with evaluations of cerebrospinal fluid (CSF) biomarkers (Amyloid Beta protein (Aβ)42, Aβ42/40 ratio, phosphorylated Tau (pTau)181) and neuroinflammation markers (Glial Fibrillary Acidic Protein (GFAP), Neurofilament light chain (NfL), Chitinase-3-like protein 1 (YKL-40)).

In terms of efficacy, NKGen Biotech reported that 70%, 60%, and 50% of patients in each dosing group showed stabilization or improvement in the three cognitive assessments (CDR-SB, ADAS-COG, MMSE) one week after the last dose.

The CSF biomarkers also showed effects of symptom stabilization or improvement. The results were as follows: Aβ42 (50% improvement), Aβ42/40 (60% stabilization or improvement; 30% improvement), pTau181 (90% stabilization or improvement; 70% improvement), GFAP (60% improvement), NfL (50% stabilization or improvement; 30% improvement), and YKL-40 (60% stabilization or improvement; 50% improvement). No SNK01-related adverse effects were observed after administration, confirming safety.

Notably, it was explained that the levels of pTau181 and neuroinflammation markers improved with increasing dosage. NKGen Biotech interpreted this as confirming that high-dose treatment may be more effective in suppressing Alzheimer's-related neuroinflammation and regulating biomarker levels. One patient in the high-dose group (4 billion cells) showed significant improvements in all three cognitive assessment scores: MMSE increased from 14 to 22, ADAS-COG decreased from 32 to 24, and CDR-SB decreased from 10 to 5.5. Lower scores on the ADAS-COG and CDR-SB scales indicate better cognitive function.

The direct therapeutic effect of SNK01 and the necessity for long-term treatment were also confirmed. Although significant cognitive improvements were observed just one week after SNK01 administration, some biomarkers showed a rebound effect 12 weeks after the last dose. Among the 8 evaluable subjects, 67% showed improvement in CDR-SB scores, and 83% showed improvement in ADAS-Cog and MMSE scores, maintaining stabilization effects.

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Photo by NKMAX

Paul Song, CEO of NKGen Biotech, stated, “Changes in CSF biomarkers and cognitive function were observed even in patients receiving low-dose SNK01. We are very satisfied with these results, which confirmed cognitive scale improvements and reductions in neuroinflammation with increasing dosage.” He added, “Considering the unmet needs for fundamental treatments that improve rather than just alleviate Alzheimer's symptoms, SNK01 is expected to become a long-term treatment that improves Alzheimer's disease without side effects.”

This content was produced with the assistance of AI translation services.