NKGen Biotech (OTC: NKGN) disclosed that its autologous natural killer cell therapy, troculeucel (SNK01), achieved encouraging outcomes in a pooled Phase 1 study of Alzheimer’s disease patients. In the study, 92 % of participants experienced stable or improved cognition, and 50 % of those with moderate‑stage disease progressed to a mild‑stage classification on the Clinical Dementia Rating–Sum of Boxes (CDR‑SB).
The data were presented at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD 2026) held in Copenhagen from March 17‑21, 2026. The presentation highlighted a clear dose‑responsive trend, with higher cell doses (4‑6 billion) associated with more frequent clinically meaningful improvements. Early durability signals were observed, as two patients followed for 12 months maintained cognitive gains, echoing earlier Phase 1 observations of sustained benefit in the highest‑dose cohort.
Exploratory plasma Glial Fibrillary Acidic Protein (GFAP) analyses revealed strong, statistically significant correlations with clinical measures (r up to 0.76, p ≤ 0.009), supporting troculeucel’s immunomodulatory mechanism. The study also reported improvements in pTau, amyloid Aβ42/40, and alpha‑synuclein biomarkers, consistent with prior observations and reinforcing the drug’s biological activity.
"As most of the attention has focused on treating the Mild Cognitive Impairment (MCI) Alzheimer's population, we wanted to focus on the moderate stage disease population for which there is no effective disease‑modifying therapy," said Paul Y. Song, M.D., Chairman and CEO. "Despite the rapid rate of cognitive decline typically seen in moderate stage patients, we were able to stop or improve cognitive decline in 100% of our patients, with 50% improving from moderate to mild stage. These results indicate that troculeucel demonstrates biological activity with dose‑related cognitive trends in moderate Alzheimer's disease and provides important translational insights as we advance our ongoing Phase 2 study for moderate stage disease which is actively enrolling."
The announcement has spurred a significant surge in NKGen’s stock, with trading at $0.15 and a market capitalization of $19.59 million as of March 23, 2026. Despite the positive clinical data, the company faces financial challenges, including a low current ratio and negative earnings per share, and has been actively amending financial agreements to secure additional funding. NKGen also received FDA Fast Track designation for troculeucel for the treatment of moderate Alzheimer’s disease in February 2025, positioning the therapy for accelerated development and potential regulatory approval.
The Phase 1 results provide translational insight for the ongoing Phase 2 trial and reinforce troculeucel’s potential to address an unmet need in moderate‑stage Alzheimer’s disease, a population with limited disease‑modifying options. The data suggest that the therapy’s dose‑responsive cognitive benefits and biomarker correlations may translate into meaningful clinical outcomes, supporting the company’s strategy to advance troculeucel through the clinical development pipeline.
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.