NKGen Biotech Presents Updated NK Cell Therapy Data for Neurodegenerative Disease at the 12th Annual Alzheimer’s & Parkinson’s Drug Development Summit - Seite 2

In the Phase 1 AD trial, SNK01 was administered intravenously (“IV”) every three weeks for a total of four treatments using a 3+3 dose escalation design (1, 2, and 4 x 10⁹ cells) in patients with either mild, moderate, or severe AD (Median MMSE of 14). Cognitive assessments and extensive CSF/plasma biomarker analyses were performed at baseline and at 1 and 12 weeks after the final dose. The primary endpoint was safety and secondary endpoints included changes in cognitive assessments and biomarker levels.

SNK01 was found to reduce and/or improve levels of pTau, amyloid Aβ42/40, and alpha-synuclein protein biomarkers suggesting that it could have utility far beyond Alzheimer’s. 90% of patients enrolled in the proof-of-concept Phase 1 had improved or stable cognitive function at week 11 using the composite ADCOMS score.

In the presentation, Dr. Song commented, “While elevated amyloid Aβ42/40 is primarily implicated in Alzheimer’s, alpha-synuclein protein levels have been noted in several other neurodegenerative diseases as well, including Parkinson’s, Lewy Body Dementia, Multiple System Atrophy, and Pure Autonomic Failure. In addition, elevated Tau levels have been associated with Frontotemporal Dementia, Progressive Supranuclear Palsy, and Corticobasal Degeneration. We believe the ability of SNK01 to have a positive impact on all three proteins suggests that it could have clinical utility for numerous neurodegenerative diseases well beyond just Alzheimer’s and Parkinson’s. In addition, based on the recent publication by Guo, et al.¹, which examined over 50,000 adults from the UK Biobank and found that GFAP, NfL, GDF15 and LTBP2 were consistently associated most with “incident all-cause dementia”, biobank specimens from the Phase 1 trial were reassessed to explore the effect of SNK01 on each of these biomarkers.”

Dr. Song further added, “In our dose escalation trial where the majority of the patients received suboptimal dosing and only four total treatments, we saw SNK01 was still able to reduce levels of all four biomarkers in at least 30% of all patients, suggesting that this could one day be potentially used as a safe preventative treatment for high-risk asymptomatic patients with elevated biomarkers especially with a higher dose. We are very impressed with the safety of SNK01 and ease of administration and its ability to cross the blood brain barrier. As more biomarker and clinical data emerge, we believe the potential applications of SNK01 will only increase.”