NKGen’s Autologous NK Therapy Proceeds to Phase 2 Trial for Alzheimer Disease


Most participants had improved or stable cognitive function in a proof-of-concept study.

NKGen Biotech is progressing its clinical trial of SNK01 natural killer cell (NK) therapy into a phase 2 trial in people with Alzheimer disease. The announcement comes after a safety review committee reviewed data from the phase 1 portion of the trial and an internal review board cleared the program to continue.1

“I am encouraged by the continued promise of NKGen’s SNK01 NK cell therapy in a difficult to treat disease such as Alzheimer’s,” Jesse Carr, MD, Medical Director, Behavioral Research Specialists, Glendale, California, who is independently overseeing the trial site, said in a statement.1 “We are seeing remarkable preliminary clinical benefit in all patients without treatment-related adverse events, including apparent improvements in cognitive function, increases in daily living activities and overall quality of life. I look forward to the potential that this novel drug candidate holds as we continue to progress the trial.”

SNK01 is an autologous NK cell therapy that is not genetically engineered but has enhanced cytotoxicity and activating receptor expression. The therapy has previously been assessed in the proof-of-concept phase 1 ASK-AD trial (NCT04678453) with a different manufacturing process. The study was an open label, 3+3 dose escalation study which demonstrated that 4 doses of 1, 2, or 4 billion SNK01 cells administered intravenously was safe and crossed the blood brain barrier to reduce amyloid, tau, and alpha-synuclein proteins. Investigators also observed a dose-dependent decrease in neuroinflammation and 90% of patients had improvements or maintenance in cognitive function as assessed by Alzheimer's disease composite score (ADCOMS).2

READ MORE: Parkinson Gene Therapy Shows Stability, Some Improvements in ON/OFF Time Disease Measures

The newer, cryopreserved SNK01 product was later cleared for a phase 1/2a trial (NCT06189963) to assess a dose of 6 billion SNK01 cells administered every 3 years for 1 year. The phase 1 portion enrolled 3 patients in which the therapy was seen to be well-tolerated. The randomized, double-blind phase 2 trial will further assess efficacy and safety in a planned 30 participants with moderate Alzheimer disease.

“We are excited to announce another important clinical milestone in our mission to advance SNK01 as the first potential disease modifying treatment of its kind for patients with more advanced Alzheimer’s disease,” said Paul Y. Song, MD, Chairman and CEO, NKGen, added.1 “The Phase 2 trial will utilize our cryopreserved SNK01 product given at the highest dose we have ever delivered, and for a full year duration. To date, SNK01 has been found to be well-tolerated with no reported drug-related adverse events. We are also very encouraged with the clinical progress we have made to date in moderate Alzheimer’s disease research and look forward to generating additional significant clinical and biomarker data from our randomized placebo-controlled Phase 2 trial.”

The FDA also recently cleared NKGen Biotech’s investigational new drug application (IND) for SNK01 to be evaluated in people with Parkinson disease. NKGen expects to dose the first of 30 planned patients in a phase 1/2a clinical trial in the second half of 2024.3

1. NKGen Biotech’s SNK01 NK Cell Therapy Cleared to Start Phase 2 Clinical Trial in Alzheimer’s Disease. News release. NKGen Biotech. May 20, 2024. https://www.globenewswire.com/news-release/2024/05/20/2884834/0/en/NKGen-Biotech-s-SNK01-NK-Cell-Therapy-Cleared-to-Start-Phase-2-Clinical-Trial-in-Alzheimer-s-Disease.html
2. NKGen Biotech Presents Updated NK Cell Therapy Data for Neurodegenerative Disease at the 12th Annual Alzheimer’s & Parkinson’s Drug Development Summit. News release. NKGen Biotech, Inc. April 25, 2024. https://nkgenbiotech.com/nkgen-biotech-presents-updated-nk-cell-therapy-data-for-neurodegenerative-disease-at-the-12th-annual-alzheimers-parkinsons-drug-development-summit/
3. NKGen Biotech announces FDA clearance of investigational new drug (IND) application for SNK01 NK cell therapy in Parkinson’s disease. News release. NKGen Biotech, Inc. April 30, 2024. Accessed April 30, 2024. https://nkgenbiotech.com/nkgen-biotech-announces-fda-clearance-of-investigational-new-drug-ind-application-for-snk01-nk-cell-therapy-in-parkinsons-disease/
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