- Cell Therapies Pty Ltd and S2N.Bio have begun technology transfer of S2N’s cell therapy candidate for Alzheimer’s disease, preparing for GMP manufacturing of clinical trial material for a first-in-human study planned in Australia in 2027.
- The collaboration will establish the cell manufacturing process, GMP analytical methods, and documentation within Cell Therapies’ quality system, building on earlier process development work conducted at the University of Technology Sydney’s Biologics Innovation Facility.
Cell Therapies Pty Ltd and S2N.Bio have begun technology transfer of a cell therapy candidate for Alzheimer’s disease to prepare for GMP manufacturing of clinical trial material. The work will support S2N’s planned first-in-human clinical study in Australia in 2027. Both companies are members of the Solutions for Manufacturing Advanced Regenerative Therapies (SMART) Cooperative Research Centre.
The technology transfer will establish S2N’s cell manufacturing process under good manufacturing practice (GMP) conditions, along with GMP analytical methods and documentation within Cell Therapies’ quality system. The companies aim to prepare the process for clinical production following development work at the University of Technology Sydney’s Biologics Innovation Facility, a GMP-like pilot biomanufacturing facility certified to ISO 9001:2015.
S2N is developing an autologous cell therapy based on hair follicle-derived neuroprecursor (HFN) cells isolated from a patient’s own hair follicles. The company says the cells are not genetically modified and are intended to replace neurons lost through neurodegeneration. The approach differs from the anti-amyloid antibodies donanemab and lecanemab, which are approved by Australia’s Therapeutic Goods Administration and are designed to clear amyloid.
S2N’s preclinical research includes a 2022 veterinary proof-of-concept trial involving autologous skin-derived neuroprecursor cells administered to five aged companion dogs with canine cognitive dysfunction. Four dogs improved on the primary clinical endpoint, and two showed complete reversal of the syndrome, according to the press release. The findings form part of the company’s preclinical foundation for developing its cell therapy for Alzheimer’s disease.
“The technology transfer marks the operational start of the company’s transition from research toward clinical development.”
Dr. Brendon Boot, CEO of S2N
Cell Therapies CEO Dr. Bev Menner said refining manufacturing processes in a GMP-like environment before transfer to a GMP facility can help reduce the risk of delays and additional costs. The collaboration supports the SMART CRC’s broader mission to develop advanced therapy manufacturing solutions and strengthen Australia’s domestic manufacturing capability.
