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NKGen Biotech Cleared to Start Clinical Trial of Alzheimer's Cell Therapy in Canada

NEW YORK – NKGen Biotech on Wednesday said it has received permission to begin a Phase I/IIa clinical trial of its Alzheimer's disease cell therapy candidate in Canada.

The company received a no-objection letter from Health Canada to begin the study, in which investigators will evaluate the safety, tolerability, and preliminary efficacy of SNK01, an autologous cell therapy for moderate Alzheimer's. NKGen is already testing the drug in clinical trials underway in Mexico and the US and enrolled the first patient in the US this month.

In the Phase I open-label portion of the Canadian trial, the company will assess the treatment's safety and determine the maximum tolerated dose for evaluation in the next phase of the trial. Phase II will be a randomized, placebo-controlled study, in which NKGen will evaluate SNK01's safety and efficacy in patients with moderate Alzheimer's.

"While the main focus of existing therapeutics continues to be on individuals with mild cognitive impairment, Health Canada has granted us the opportunity to direct our endeavors towards a more advanced population currently lacking any approved disease-modifying therapy," NKGen CEO Paul Song said in a statement.

For example, Biogen and Eisai's Leqembi (lecanemab), which received full approval from the US Food and Drug Administration in July, targets beta-amyloid, a protein fragment, to slow disease progression in Alzheimer's patients with mild cognitive impairment or mild dementia.

In clinical trials so far, investigators have found that SNK01 is well tolerated in patients and reduces neuroinflammation, according to Santa Ana, California-based NKGen. According to a readout from a Phase I trial earlier this year, nine out of 10 patients had improved or stable cognitive function with SNK01 treatment one week after baseline assessments.

NKGen plans to enroll about 36 patients with moderate Alzheimer's in the Canadian trial. The Phase I/IIa trial will test a higher SNK01 dose and prolonged dosing schedule compared to the Phase I dose-escalation study that was initiated in Mexico.

The firm expects the first interim data from the Phase I/IIa trial in Q3 2024.