NKMAX Announces Alzheimer's Clinical Trial Results: "Efficacy and Safety Confirmed"

NKMAX disclosed the efficacy and safety of its NK cell therapy SNK01 for the treatment of Alzheimer's disease.

CEO Paul Song of NK Gen Biotech explaining at AAIC. Photo by NK Max

NKMAX’s subsidiary NKGEN Biotech announced on the 17th that it presented interim results of its Phase 1 clinical trial for Alzheimer's at the Alzheimer's Association International Conference (AAIC 2023) in a poster session.

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 once every three weeks for a total of four doses. Cognitive assessments (CDR-SB, ADAS-COG, MMSE) were conducted one week and twelve weeks after the last SNK01 administration, along with cerebrospinal fluid (CSF) biomarker evaluations (Aβ42, Aβ42/40, pTau181) and neuroinflammation markers (GFAP, NfL, YKL-40).

In terms of efficacy, the three cognitive assessments showed that 70%, 60%, and 50% of patients in each dosing group respectively were stabilized or improved one week after the last dose. CSF biomarkers also indicated stabilization or improvement of symptoms.

The confirmed biomarkers included 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, increases in dosage corresponded with improvements in pTau181 and neuroinflammation markers. This result suggests 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 an increase in MMSE score from 14 to 22. The ADAS-cog score decreased from 32 to 24, and the CDR-SB score decreased from 10 to 5.5, indicating significant improvement across all three cognitive assessment indices. Lower scores on the ADAS-cog and CDR-SB scales indicate better cognitive function.

The direct therapeutic effect of SNK01 and the need for long-term treatment were also confirmed. Significant cognitive improvements were observed just one week after SNK01 administration; however, 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% of patients showed improvement in ADAS-Cog and MMSE scores, maintaining stabilization effects.

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 the results confirming cognitive scale improvements and reductions in neuroinflammation with increased dosage.” He added, “Considering the unmet need for fundamental treatments that improve rather than just alleviate Alzheimer's symptoms, SNK01 is expected to be a treatment that can improve Alzheimer's disease long-term without side effects.”

Meanwhile, NKMAX filed a U.S. patent last September related to neurodegenerative disease treatments using 'Super NK (SNK)'. Additionally, together with Graf Acquisition Corp. IV, a special purpose acquisition company listed on the New York Stock Exchange, NKMAX plans to hold a large-scale investor relations event targeting research analysts and institutional investors on July 20 at the Lotte New York Palace Hotel.

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