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FDA Clears NKGen Biotech to Start US Trials of Alzheimer's Cell Therapy

NEW YORK – The US Food and Drug Administration has granted NKGen Biotech permission to begin clinical trials of its cell therapy for moderate Alzheimer's disease, the biotechnology firm said Tuesday.

The FDA cleared NKGen's investigational new drug (IND) application for SNK01, an autologous cell therapy for which the company has already launched a Phase I dose-escalation study in Mexico. Investigators so far have found the therapy is well tolerated and helped reduce proteins and neuroinflammation in patients.

Santa Ana, California-based NKGen is planning to launch a Phase I/IIa trial with 30 moderate Alzheimer's patients in the US by year-end and expects the first interim data from the study in the third quarter of 2024.

"Based on the data generated from our Phase I dose-escalation safety trial, which will be presented at the CTAD annual conference this week, we are optimistic that our planned Phase I/IIa clinical trial may show even greater cognitive benefit and a further reduction in neuroinflammation in patients given the planned higher and prolonged dosing regimen," NKGen CEO Paul Song said in a statement.

NKGen earlier this year announced plans to go public through a merger with special purpose acquisition company Graf Acquisition Corp. IV, which it said would provide funding for its clinical development programs.