Cell Therapies Pty Ltd and S2N.Bio have initiated the technology transfer process for a new cell therapy targeting Alzheimer’s disease, marking a significant step toward clinical trials in Australia. This collaboration aims to establish good manufacturing practice (GMP) standards for the production of clinical trial materials for S2N’s first-in-human study, anticipated for 2027.
The development is supported by the Solutions for Manufacturing Advanced Regenerative Therapies (SMART) Cooperative Research Centre, which is co-funding parts of the project as it seeks to propel innovative health technologies from research into clinical applications.
The technology transfer will enable the establishment of S2N’s cell manufacturing processes under GMP conditions, along with necessary analytical methods and documentation to fit within Cell Therapies’ quality system for upcoming clinical production.
S2N is focused on developing an autologous cell therapy that seeks to replace neurons lost due to neurodegeneration. The therapy employs hair follicle-derived neuroprecursor (HFN) cells, which are isolated from the patient’s hair follicles. These unipotent cells differentiate exclusively into neurons and related cells and are not genetically modified.
This approach differs from existing Alzheimer’s treatments approved by the Therapeutic Goods Administration (TGA), including donanemab and lecanemab, which function as anti-amyloid antibodies. While these treatments can modestly slow cognitive decline by eliminating amyloid plaques, they do not restore lost functionality. In contrast, S2N’s therapy aims directly to replace the neurons damaged by the disease.
“Partnering with Cell Therapies supports our transition from research into the clinical setting, and the start of technology transfer is the point at which that transition becomes operational,”
Dr. Brendon Boot, Chief Executive Officer, S2N.Bio
S2N’s preclinical research includes a notable veterinary trial published in 2022 in Stem Cell Research & Therapy, which demonstrated the efficacy of their therapy in aged dogs with cognitive dysfunction resembling Alzheimer’s. Among the five treated dogs, four showed improvement based on primary clinical endpoints, with two achieving a complete reversal of the condition. This study contrasts with many other companies that primarily rely on rodent models, offering insights from a naturally occurring disease that parallels human Alzheimer’s.
Prior to the technology transfer, S2N refined its cell manufacturing processes at the University of Technology Sydney’s Biologics Innovation Facility, which operates under GMP-like conditions. S2N’s team collaborated with Cell Therapies to complete development-scale production runs, further facilitating the ongoing manufacturing campaign.
Dr. Bev Menner, CEO of Cell Therapies, remarked on the importance of pre-GMP process development, noting that it significantly reduces project timelines and costs. She indicated that the clinical-grade facility will enable the production of S2N’s Alzheimer’s therapy, leading to trial data that meet regulatory standards for international progression.
