Core Insights - The Phase 1 clinical trial of Troculeucel demonstrated stable or improved outcomes in 90% of subjects, with no drug-related adverse events reported [1][4] - Troculeucel therapy showed beneficial effects on neuroinflammatory biomarkers and protein aggregate levels in cerebrospinal fluid, with decreases in pTau181 and GFAP appearing dose-dependent [1][4] - A larger trial with higher dosing and duration has been initiated in the U.S. [1] Company Overview - NKGen Biotech, Inc. is a clinical-stage biotechnology company focused on developing innovative autologous and allogeneic natural killer (NK) cell therapeutics [2][7] - The company is headquartered in Santa Ana, California, and is publicly traded on NASDAQ under the ticker NKGN [7] Clinical Trial Details - The Phase 1 trial involved 11 subjects (5 males and 6 females), with a median age of 79 years [4] - The trial utilized a 3 + 3 design to identify the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), with three dose cohorts receiving four doses at three-week intervals [4] - Despite 70% of subjects being treated at relatively low doses, 90% had stable or improved composite ADCOMS scores at week 11 [4] Publication and Validation - Results from the Phase 1 trial were published in the journal Alzheimer's Research & Therapy, enhancing the credibility of the findings [2][4] - The publication includes comprehensive details on the preparation of Troculeucel, preclinical studies, clinical trial design, and results [3][4] Future Directions - NKGen is currently enrolling patients for a follow-up Phase 1/2a trial on Troculeucel in moderate Alzheimer's disease [5] - The company aims to advance the scientific understanding of Troculeucel as a potential treatment option for Alzheimer's and other neurodegenerative diseases [4][6]
NKGen Biotech Announces Publication of Phase 1 Troculeucel Clinical Trial Results for the Treatment of Alzheimer's Disease