NKMAX, Alzheimer's Phase 1 Success... "Treatment Effect Confirmed in 90% of Patients"

NKMAX has successfully completed Phase 1 clinical trials by demonstrating safety and efficacy in Alzheimer's disease.

NKMAX announced on the 26th (local time) that its subsidiary, NKGen Biotech, participated in the Clinical Trials on Alzheimer's Disease (CTAD) conference in the United States and presented the final data of SNK01 (autologous NK cell therapy) Phase 1 clinical trial for Alzheimer's disease.

The CTAD conference is a prestigious event for sharing Alzheimer's clinical trial results. It is held from the 24th to the 27th of this month in Boston, USA. NKGen Biotech disclosed the final results of the Phase 1 clinical trial involving a total of 10 Alzheimer's patients (mild = 5, moderate to severe = 5) through a poster presentation at this conference.

NKGen Biotech conducted cognitive assessments (CDR-SB, ADAS-COG, MMSE, ADCOMS) at 1 week (week 11) and 12 weeks (week 22) after the last SNK01 administration and evaluated cerebrospinal fluid (CSF) biomarkers (Aβ42/40, pTau181) and neuroinflammation markers (GFAP, NfL). Patients were divided into low-dose (1 billion cells), medium-dose (2 billion cells), and high-dose (4 billion cells) groups and received intravenous infusions once every 3 weeks for a total of 4 times. This clinical trial was conducted in Mexico.

The Phase 1 trial results demonstrated both safety and efficacy in the SNK01 treatment groups. Notably, in terms of efficacy, effects differentiated from existing drugs were observed. Current treatments only slow the progression of Alzheimer's disease but do not completely halt or improve it. In contrast, NKMAX confirmed that SNK01 administration prevented disease progression and even showed improvement, successfully completing the clinical trial.

Among the four cognitive assessments used to verify efficacy, effects appeared just one week after the fourth SNK01 administration. One week after the last administration, the Alzheimer's Disease Composite Score (ADCOMS) showed treatment effects in 90% of patients. Thirty percent of patients exhibited meaningful improvement, and 60% showed no disease progression. Notably, one patient's ADCOMS score improved from moderate to mild, confirming SNK01's efficacy even in severe Alzheimer's patients. Additionally, 50-70% of patients showed maintenance or improvement in total scores of clinical dementia rating (CDR-SB), Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), and Mini-Mental State Examination (MMSE).

These effects were maintained over time after the last SNK01 administration. At 12 weeks (week 22) post-final administration, approximately 78% of patients, including those with moderate and severe conditions, maintained or improved all cognitive assessment scores compared to week 11. In particular, MMSE scores showed sustained treatment effects in about 89% of patients. Furthermore, SNK01 reduced CSF biomarkers pTau181 and neuroinflammation marker GFAP. The high-dose group showed outstanding effects, which persisted even at 12 weeks after the last administration.

Recently, NKGen Biotech received approval from the U.S. Food and Drug Administration (FDA) for an IND plan for a Phase 1/2a clinical trial administering 6 billion SNK01 cells to patients with moderate Alzheimer's disease. Since the completed Mexican trial administered up to 4 billion cells and demonstrated efficacy in moderate to severe patients, even more remarkable results are expected in the U.S. trial. Previously, NKMAX confirmed significant cognitive improvements in patients who received up to 8 billion SNK01 cells through the Expanded Access Program (EAP).

Paul Song, CEO of NKGen Biotech, stated, “In this Phase 1 Alzheimer's clinical trial, we confirmed the potential of SNK01 to overcome the limitations of existing Alzheimer's treatments,” adding, “Following the successful completion of the Mexican Phase 1 trial, we will conduct a more advanced Phase 1/2a Alzheimer's trial in the United States.”