NKGen Biotech has announced promising early interim data from the Phase I cohort trial of troculeucel, its cryopreserved autologous enhanced natural killer (NK) cell therapy for moderate Alzheimer’s disease (AD).

An early independent review of the Phase I data shows that after three months treatment with a dose of six billion cells per treatment, the three patients in the Phase I cohort had no drug-related adverse reactions.

Exploratory efficacy analyses showed that two of the patients went from a moderate to a mild AD rating on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale.

These findings support the company’s MX04 Phase I AD study, where the one moderate AD patient who received the highest dose in that study (four billion cells) also went from a moderate to a mild rating.

The company also launched a Phase I/II study, to evaluate the effectiveness and additional safety of troculeucel in a broader cohort of 30 patients with moderate AD.

“We continue to make great progress with our troculeucel clinical programme in AD,” said Paul Song, Chairman and CEO of NKGen. “In the Phase I cohort of the Phase I/IIa study, we can proudly announce two of our first three patients have been clinically upgraded from moderate to mild AD following only three months of treatment with troculeucel.

“With encouraging cognitive improvements and a favourable safety profile from the trial’s Phase I interim analysis, dosing our first patient in Phase II is a crucial step towards creating a much-needed treatment option for patients facing this challenging condition. We are particularly eager to explore the enhanced cognitive benefits that ongoing usage of the higher dosing may bring in our Phase II trial.”

Read the DDW interview with Paul Song.

Diana Spencer, Senior Digital Content Editor, DDW