SANTA ANA, Calif., March 23, 2026 (GLOBE NEWSWIRE) — NKGen Biotech, Inc. (OTC: NKGN) has reported encouraging findings from its combined Phase 1 analyses of troculeucel data, presented at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD™ 2026), which took place from March 17-21, 2026, in Copenhagen, Denmark, and virtually.
The pooled analyses, focusing on patients with moderate Alzheimer’s disease (AD), have shown a dose-related cognitive benefit and promising signs of durability. Remarkably, 100% of the patients either maintained or improved their cognitive function, with 50% of participants demonstrating an enhancement from moderate to mild cognitive function.
Furthermore, exploratory plasma Glial Fibrillary Acidic Protein (GFAP) correlations were found to be consistent with the observed clinical outcomes. These findings lend support to the immunomodulatory approach of troculeucel, warranting further investigation in the ongoing Phase 2 trial.
Encouraging Clinical Results
The analyses included data from two previously completed open-label Phase 1 trials of troculeucel in Alzheimer’s disease, indicating notable biological activity. An impressive 92% of patients exhibited stable or improved cognitive function. Analyses focused specifically on the moderate stage population revealed clear dose-responsive cognitive trends, with no decline observed across all treated patients. Notably, higher doses were linked to more frequent clinically meaningful improvements, and early signs of durability were identified at the 12-month assessment.
Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen Biotech, stated, “As most of the attention has focused on treating the Mild Cognitive Impairment (MCI) Alzheimer’s population, we aimed to address the moderate stage disease population, where effective disease-modifying therapy is lacking. Our findings indicate that troculeucel shows biological activity with dose-related cognitive trends in moderate Alzheimer’s disease, providing important insights as we advance our ongoing Phase 2 study. We believe the consistency observed across cognitive measures, preliminary durability, and GFAP biomarker correlations support troculeucel’s potential to address this unmet need.”
Data Highlights from Oral Presentations
The pooled analysis revealed:
- 100% of patients were stable or improved across all established minimal clinically important difference (MCID) thresholds, including:
- Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog; ± 4 points)
- Clinical Dementia Rating-Sum of Boxes (CDR-SB; ± 2 points)
- Alzheimer’s Disease Composite Score (ADCOMS; ± 0.1 points)
- No cognitive decline was reported in any patient.
- Higher doses (4–6 billion cells) correlated with greater directional improvement and more frequent exceedance of MCID.
- 50% of patients improved from moderate to mild range on CDR-SB at the three-month assessment.
Durability and Safety
In the two patients who continued therapy for 12 months, improvements across cognitive measures were sustained throughout treatment, suggesting early durability of effect. Troculeucel was well tolerated, with no treatment-related adverse events reported across both Phase 1 studies.
Exploratory Plasma GFAP Findings
In a separate poster presentation, NKGen reported on exploratory plasma GFAP analyses from all AD patients treated across the two Phase 1 studies. The results demonstrated strong and consistent correlations between GFAP levels and established clinical measures of disease severity. These correlations were observed at baseline, maintained following troculeucel treatment, and further enhanced in patients receiving higher cell doses, reinforcing the potential of plasma GFAP as a reliable, non-invasive biomarker of neuroinflammation and clinical status.
The data summary indicated:
- Baseline plasma GFAP demonstrated strong and statistically significant correlations with cognitive status.
- Baseline plasma GFAP levels correlated with CDR-SB (r=0.60, p=0.044) and ADCOMS (r=0.64, p=0.030).
These findings provide important translational support as NKGen advances the clinical development of troculeucel in the treatment of Alzheimer’s disease.