NKMAX "Alzheimer's Treatment Phase 1 Clinical Trial Dosing Schedule Confirmed"

[Asia Economy Reporter Hyunseok Yoo] NKMAX announced on the 22nd that the first injection schedule for three subjects receiving 1 billion cells of the Super NK autologous immune cell therapy (SNK01) has been confirmed for January 29 next year. The clinical subjects will receive a total of four doses of SNK01 at three-week intervals.

This clinical trial is being conducted on 21 Alzheimer's patients. Among them, 9 patients (Cohort 1-3) will be administered 1 billion, 2 billion, and 4 billion cells of SNK01 to evaluate the Maximum Tolerated Dose (MTD). Twelve patients (Cohort 4) will confirm the safety, tolerability, and exploratory efficacy of the maximum tolerated dose.

Exploratory efficacy will be evaluated using the Alzheimer’s Disease Assessment Scale - Cognitive Subscale (ADAS-Cog), Mini-Mental Status Exam (MMSE), and two other scales. ADAS-Cog is widely used as a representative evaluation index in Alzheimer's clinical trials. Additionally, biomarkers such as amyloid beta 42, T-tau, and P-tau proteins in cerebrospinal fluid (CSF) will also be used as efficacy evaluation indicators.

Park Sang-woo, CEO of NKMAX, said, “We are currently screening patients for this clinical trial at Hospital Angeles Tijuana in Mexico. Recently, we completed the selection of eight patients and finalized the schedule for the low-dose group (Cohort 1).” He added, “As of this year, there are more than 50 million Alzheimer's patients worldwide, and the treatment market is approximately 1,100 trillion KRW (1 trillion USD), but there is still no appropriate treatment, making it a blue ocean for the pharmaceutical industry.” He continued, “Global pharmaceutical companies have shown interest in Super NK, which is expected to be the only Alzheimer's treatment worldwide, and we are currently discussing technology cooperation with them.”

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