NKGen Biotech's Troculeucel Shows Promise in Early Alzheimer's Trial, Advances to Phase 2
核心洞察
NKGen Biotech's troculeucel, an autologous NK cell therapy, demonstrated cognitive improvement in moderate Alzheimer's patients in a Phase 1 trial.
Two of three patients treated with the highest dose of troculeucel showed improvement on the CDR-SB scale, moving from moderate to mild Alzheimer's.
The Phase 2 trial, a randomized, double-blind, placebo-controlled study, has dosed its first patient and will evaluate troculeucel in a larger cohort.
NKGen Biotech has announced positive interim data from its Phase 1 clinical trial of troculeucel for moderate Alzheimer's disease (搜索) (AD), leading to the advancement of the therapy into Phase 2. The Phase 1/2a trial's early results showed cognitive improvements in patients treated with troculeucel, an autologous natural killer (NK) cell therapy.
Phase 1 Interim Results
The Phase 1 cohort, treated with 6 billion cells of troculeucel per treatment, demonstrated promising results. An independent review of the data revealed that two of the first three patients experienced a clinical upgrade from moderate to mild AD after three months of therapy, as measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale. Notably, no drug-related adverse reactions were observed.
"We continue to make great progress with our troculeucel clinical program in AD," said Paul Y. Song, MD, Chairman and CEO of NKGen. "In the Phase 1 cohort of the Phase 1/2a 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."
Phase 2 Trial Commences
Building on the Phase 1 findings, NKGen has initiated the Phase 2 portion of the trial, a randomized, double-blind, placebo-controlled study. The first patient in the Phase 2 cohort has been dosed, continuing at the highest dose of 6 billion cells per treatment. The trial will evaluate the efficacy and safety of troculeucel in a broader cohort of 30 patients with moderate Alzheimer’s disease, with 20 patients randomly assigned to the treatment arm and 10 to placebo. Four clinical sites across North America are currently active, with plans to increase enrollment.
The Phase 2 trial aims to validate the potential therapeutic efficacy of troculeucel and provide a thorough understanding of its benefits and limitations in treating Alzheimer’s disease.
About Troculeucel
Troculeucel, formerly known as SNK01, is a novel cell-based, patient-specific ex vivo expanded autologous natural killer (NK) cell immunotherapeutic drug candidate. NKGen is developing troculeucel for the treatment of neurodegenerative disorders and a broad range of cancers. The World Health Organization (WHO) has assigned troculeucel as the International Nonproprietary Name (INN) for SNK01.