NKGen Biotech Reveals Positive SNK01 Biomarker Data at 2024 Alzheimer's Conference

NKGen Biotech, Inc., a clinical-stage biotechnology company, has presented promising data on its autologous, non-genetically modified natural killer cell product, SNK01, at the 2024 Alzheimer’s Association International Conference. SNK01 has demonstrated its ability to decrease α-synuclein protein levels in the cerebrospinal fluid (CSF) of Alzheimer's Disease (AD) patients—a significant finding given that elevated α-synuclein levels are associated with worsening cognitive function in these individuals. Current Alzheimer's treatments do not target α-synuclein, making SNK01 a novel approach in the field.

SNK01 is an innovative NK cell product characterized by its high cytotoxicity and over 90% activating receptor expression. These cells are derived from patients themselves, making them a personalized form of therapy. The clinical trial data presented at the conference revealed that SNK01 not only reduces α-synuclein levels but also stabilizes or improves cognitive function in most patients.

Findings from in vitro studies, as well as initial Phase I clinical trials, highlighted SNK01’s potential. The in vitro studies showed that SNK01 could internalize and break down α-synuclein aggregates, similar to microglial cells, supporting its use for treating α-synucleinopathies like Alzheimer’s. The Phase I trials indicated improvements in CSF levels of not just amyloid and tau proteins, but also markers of neuroinflammation such as GFAP, YKL-40, and NfL.

A subsequent analysis focused on SNK01's effect on α-synuclein levels in CSF. Despite 70% of the trial subjects receiving relatively low doses of SNK01, 60% experienced a reduction in their CSF α-synuclein levels. Further, 90% of these patients showcased stable or improved cognitive function, as measured by the ADCOMS score, at 11 weeks into the treatment.

Dr. Paul Y. Song, Chairman and CEO of NKGen, emphasized the significance of these findings, noting that no current Alzheimer's treatments target α-synuclein along with amyloid and tau while also reducing neuroinflammation. The new data suggest that SNK01 can target α-synuclein and improve cognitive function, which is a breakthrough in Alzheimer's treatment. NKGen is planning a larger Phase II trial with higher doses and a longer treatment duration to further investigate SNK01's efficacy.

The presentation showcased several key data points:
- SNK01 effectively internalizes and degrades α-synuclein aggregates in vitro.
- 90% of evaluable subjects had stable or improved cognitive scores at week 11.
- 60% of subjects showed reduced CSF α-synuclein levels.
- No treatment-related adverse events were observed, indicating SNK01’s safety.
- SNK01 appears to cross the blood-brain barrier and impact both cognition and protein aggregates in Alzheimer's patients.

NKGen Biotech plans to explore SNK01's potential in other neurodegenerative diseases related to synucleinopathies. The company remains committed to advancing the development of SNK01 and expanding its therapeutic applications. This groundbreaking work positions NKGen at the forefront of Alzheimer's research, offering hope for new, effective treatments for this devastating disease.

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