MELBOURNE, Australia — 15th October 2026 — Cell Therapies Pty Ltd and S2N.Bio (“S2N”) have commenced technology transfer of S2N’s cell therapy candidate for Alzheimer’s disease. The transfer will enable GMP manufacture of clinical trial material for S2N’s first-in-human study in Australia.
CTPL and S2N are collaborating members of the Solutions for Manufacturing Advanced Regenerative Therapies (SMART) Cooperative Research Centre (CRC) (“SmartCRC”), which is co‑funding elements of the project as part of its mission to accelerate the translation of innovative health technologies from research through to clinical and commercial outcomes.
The technology transfer will establish S2N’s cell manufacturing process under GMP conditions, establish GMP analytical methods, and documentation within Cell Therapies’ quality system, ahead of GMP clinical production for the 2027 clinical trial.
S2N is an Australian regenerative medicine company developing an autologous cell therapy intended to replace neurons lost through neurodegeneration. The therapy is based on hair follicle-derived neuroprecursor (HFN) cells, a cell population isolated from a patient’s own hair follicles. The cells are unipotent, differentiating only into neurons and related cells, and are not genetically modified.
S2N’s approach is mechanistically distinct from Alzheimer’s therapies currently on the market. The two recent agents approved by the Therapeutic Goods Administration (TGA), donanemab and lecanemab, are anti-amyloid antibodies that slow cognitive decline by clearing amyloid. The slowing of disease by these agents is modest, and they cannot recover function that has already been lost. S2N’s unique cell therapy targets that gap directly: it is designed to replace the neurons lost to 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,” said Dr Brendon Boot, Chief Executive Officer of S2N.
S2N’s preclinical foundation includes a proof-of-concept veterinary trial published in Stem Cell Research & Therapy in 2022. Autologous skin-derived neuroprecursor cells were microinjected into the hippocampus of aged companion dogs with canine cognitive dysfunction, a naturally occurring syndrome that closely parallels Alzheimer’s disease. Four of the five treated dogs improved on the primary clinical endpoint, and two showed complete reversal of the syndrome. This veterinary trial sets S2N apart from other companies dedicated to the treating Alzheimer’s. Most companies rely on studies in rodent models of Alzheimer, which do not predict results in humans. In contrast, S2N’s canine trial provides evidence of functional recovery in a naturally occurring disease that shares the pathological and clinical aspects with human Alzheimer’s.
Process development and technology transfer
Before transferring to Cell Therapies, S2N refined its cell manufacture process in the University of Technology Sydney’s (UTS) Biologics Innovation Facility (BIF). The BIF is an ISO 9001:2015-certified, Good Manufacturing Practice (GMP)-like pilot biomanufacturing facility.
S2N worked in in the BIF establish reproducibility, generate process documentation, and conduct development-scale production runs under GMP-like conditions. Members of the CTPL team joined S2N to complete the latter batches, smoothing the path for the CTPL manufacture campaign now underway.
“The maturity of the process development work completed before a program reaches a GMP facility has a measurable effect on timelines and cost,” said Dr Bev Menner, Chief Executive Officer of Cell Therapies. “Companies that refine their process in GMP-like environment before technology transfer significantly derisk the chances of delay and additional expense.”
Dr Menner said that S2N’s Alzheimer cell therapy will be manufactured in a world-class, clinical-grade facility.
“Clinical trial data generated in Australia using products made using a GMP process are generally acceptable to Regulators such as the FDA and EMA, so companies who do early stage trials following a GMP process in Australia can progress to later stage international clinical trials very efficiently.”
