December 29, 2023 – NKGen Biotech, Inc. (Nasdaq: NKGN) is making strides in Alzheimer’s disease (AD) treatment with the dosing of the first patient in its Phase 1/2a trial for SNK01, an autologous natural killer (NK) cell therapy. The innovative product, designed for moderate AD, has demonstrated promising results in neuroinflammation and cognitive function during its Phase 1 safety trial.
SNK01 Efficacy: NKGen’s SNK01, a cryopreserved autologous NK cell therapy, showed improvement in neuroinflammation and cognitive function in the Phase 1 dose-escalation safety trial. The therapy boasts enhanced cytotoxicity and activating receptor expression.
Dosing Details: The initial patient in the Phase 1/2a trial received a substantial dose of 6 billion cells, 50% more than the maximum dosing from the Phase 1 trial. This trial aims to evaluate the safety and tolerability of SNK01 in participants with moderate AD.
Trial Structure: The Phase 1 is an open-label safety assessment determining the maximum tolerated dose and/or recommended Phase 2 dose of SNK01. The subsequent Phase 2 is a randomized double-blind trial assessing both safety and efficacy in moderate AD patients.
Addressing Advanced AD Population: NKGen’s focus on the moderate AD population, lacking approved disease-modifying therapies, distinguishes its approach from traditional treatments that target milder conditions. Previous findings indicate the safety of enhanced NK cells, administered intravenously, in positively impacting brain protein aggregates and neuroinflammation.
Optimizing Dosing Regimen: Despite suboptimal dosing in 2/3 of Phase 1 trial patients, 90% exhibited stable or improved cognitive function. The new randomized trial plans to administer 6 billion cells per dose every three weeks for a year, totaling 17 doses. This intensified dosing regimen aims to demonstrate enhanced cognitive benefits and greater effects on protein and neuroinflammation levels.
NKGen Biotech’s commitment to advancing NK cell therapeutics positions SNK01 as a potential breakthrough in the treatment of moderate Alzheimer’s disease, addressing a critical gap in available therapies. The Phase 1/2a trial marks a significant step forward in evaluating the safety and efficacy of this promising autologous NK cell product.