Core Insights - The Phase 1 clinical trial of Troculeucel showed stable or improved outcomes in 90% of subjects, with no drug-related adverse events reported [1][4] - Troculeucel therapy demonstrated a well-tolerated profile and beneficial effects on neuroinflammatory biomarkers and protein aggregate levels in cerebrospinal fluid [1][4] - A larger trial with higher dosing and duration is currently ongoing 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 determine 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 receiving relatively low doses, 90% had stable or improved composite ADCOMS scores at week 11 [4] Treatment Mechanism and Efficacy - Troculeucel therapy reduced neuroinflammation and positively affected brain protein aggregates, suggesting potential cognitive function stabilization or improvement [4] - The therapy's ability to degrade protein aggregates indicates possible therapeutic and disease-modifying benefits [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 provides comprehensive details on the trial's design, safety, efficacy, and biomarker assessments [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 for Alzheimer's and other neurodegenerative diseases [4][5]
NKGen Biotech Announces Publication of Phase 1 Troculeucel Clinical Trial Results for the Treatment of Alzheimer's Disease