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NKGen Gets FDA Permission to Test NK Cell Therapy in Parkinson's Patients

NEW YORK – The US Food and Drug Administration has cleared NKGen Biotech's investigational new drug application for SNK01, allowing the firm to begin testing the autologous investigational NK cell therapy as a treatment for Parkinson's disease patients.

In an announcement Monday, the Santa Ana, California-based firm said it would start a Phase I/IIa trial to gauge SNK01's safety, tolerability, and initial efficacy in up to 30 Parkinson's patients. NKGen is aiming to give 20 patients SNK01 and 10 patients a placebo in this trial slated to begin dosing in the second half of this year.

NKGen is also studying SNK01 for Alzheimer's disease in a Phase I/IIa clinical trial being conducted in Canada, Mexico, and the US. In the Phase I portion, the company is assessing safety and establishing the maximum tolerated dose of SNK01. In the randomized Phase II portion, researchers are comparing the cell therapy's efficacy and safety against a placebo in Alzheimer's patients.

NKGen Chairman and CEO Paul Song said in a statement that in the Phase I portion of the Alzheimer's trial, SNK01 has reduced neuroinflammation, which is also a biological consequence of Parkinson's.

"Although these two neurodegenerative diseases differ, both share a neuroinflammatory component, which has led to our hypothesis that SNK01 may be beneficial in both indications," Song said. "While directly inhibiting neuroinflammation, whether as an independent approach or in conjunction with other interventions, may not address the etiology, it can potentially decrease the production of factors that contribute to neurotoxicity, thereby hopefully leading to clinical improvements."