NKGen Receives FDA Expanded Access Protocol Authorization for Landmark Treatment of Several Neurodegenerative Diseases

Core Insights - NKGen Biotech has received FDA authorization for an Expanded Access Program (EAP) for its IND to use troculeucel in treating neurodegenerative diseases, which currently lack effective therapies [1][8] - The EAP will allow the exploration of troculeucel in various neurodegenerative diseases beyond Alzheimer's, including Parkinson's Disease, ALS, and others [2][4] - The IND approval permits enrollment of up to 20 patients, with the first patient expected to be enrolled in Q3 2025 [3][8] Company Overview - NKGen Biotech is a clinical-stage biotechnology company focused on developing autologous and allogeneic NK cell therapeutics [5] - The company is headquartered in Santa Ana, California, and aims to commercialize innovative therapies for neurodegenerative disorders and cancers [5][6] Product Information - Troculeucel is a novel, patient-specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate, recognized by the WHO as SNK01 [6] - Preliminary clinical trials have shown that troculeucel can cross the blood-brain barrier and reduce neuroinflammatory and protein biomarkers in cerebrospinal fluid [4][8]