NKGen Biotech has activated two new trial sites in Canada and Florida, US, for the Phase I/IIa study of its cryopreserved expanded autologous natural killer (NK) cell therapy, troculeucel, in patients with moderate Alzheimer’s disease.
A leader in Alzheimer’s disease research, the Ottawa Memory Clinic will be a primary location for Canadian participants and is led by neuroscientist Dr Richard Bergeron.
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In the US, AdventHealth Orlando will begin subject enrolment under the guidance of Dr Anita Fletcher.
The activation of these sites follows NKGen’s receipt of clearance from Health Canada for its clinical trial application (CTA), permitting the inclusion of Canadian subjects in the trial.
Troculeucel is the international, non-proprietary name (INN) for SNK01, assigned to it by the World Health Organization (WHO). The therapy is being developed by the company for the treatment of neurodegenerative disorders and a wide range of cancers.
The WHO’s INN approval is an important step for NKGen as it moves towards commercialising the therapy.
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By GlobalDataThe company noted that site activation is a pivotal step in clinical trials, involving comprehensive preparations, such as staff training and protocol setup.
Site activation allows the sites to start patient recruitment and ensures that the trial progresses on schedule.
NKGen Biotech CEO and chairman Dr Paul Song said: “We are thrilled to welcome Dr Bergeron to our global clinical trial team. His expertise in Alzheimer’s research will be invaluable as we expand patient trial access to troculeucel and work toward fulfilling our enrolment goals.
“As Alzheimer’s is a global health problem, we are committed to working with more international experts and clinical sites. The activation of the US East Coast and Canadian sites is a step towards expanding the geographic footprint of our Phase I/IIa trial, enhancing patient diversity and trial efficiency.”
In 2023, NKGen Biotech dosed the first subject in a Phase I trial of SNK02 to treat solid tumours.
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