Santa Ana, California–based NKGen Biotech has received FDA clearance to begin a phase 1/2a trial for their “natural killer” cell therapy, SNK01, designed to treat Alzheimer’s Disease. The autologous, non-genetically modified natural killer (NK) cell therapy involves extracting a patient’s own cells through a blood draw, and then processing them to enhance their natural abilities in a laboratory setting before reinfusing them into the patient’s body.

NKGEN Biotech modifies NK cells to improve their cytotoxicity and their activating receptor expression, which helps them to identify and engage with target cells. This process imparts the NK cells with the ability to target and combat the specific cells associated with Alzheimer’s.

Early data are promising

Data from a phase 1, 3 + 3 dose-escalation trial found SNK01 to be well-tolerated. The drug candidate appeared to cross the blood-brain barrier to help reduce proteins and neuroinflammation in a dose-dependent manner. Clinical investigators did not observe any related serious adverse effects. Additionally, they reported no dose-limiting toxicities, while observing positive changes in cognitive function and cerebrospinal fluid biomarkers.

Traditional Alzheimer’s treatments focus mainly on mitigating symptoms rather than halting or reversing disease progression. Common treatments include cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine, as well as glutamate regulators like memantine.

Growing success in treating Alzheimer’s

In recent years, drug developers have had increasing success with monoclonal antibodies for Alzheimer’s. One of the most notable is lecanemab, which scored traditional FDA approval in July. It won accelerated approval near the beginning of the drug. In clinical trials, lecanemab has shown promise in reducing cognitive decline in patients with mild cognitive impairment resulting from Alzheimer’s, with a 27% reduction in cognitive decline over 18 months observed in phase 3 clinical trials. Another promising monoclonal antibody is donanemab, which could potentially win FDA approval by the year’s end. In the phase 3 TRAILBLAZER-ALZ 2 study, nearly half (47%) of the participants on donanemab had no clinical progression at one year, defined as no decline in Clinical Dementia Rating-Sum of Boxes (CDR-SB). Donanemab treatment also resulted in 40% less decline in the ability to perform activities of daily living.

NKGen Biotech’s SNK01 therapy, like J&J’s ACI-35.030 Alzheimer’s-focused active immunotherapy, intend to coax the body into combating the underlying causes of Alzheimer’s disease. While the monoclonal antibodies target amyloid plaques in the brain, NKGen’s SNK01 therapy taps the body’s natural killer cells to combat Alzheimer’s disease. J&J’s ACI-35.030 vaccine targets the tau protein, aiming to reduce its spread in the brain.

NKGen Biotech’s NK cell therapy candidate, SNK01, is undergoing development for both oncology and neurodegeneration. The company’s SNK02 (allogeneic NK cell therapy) is also in phase 1.