Melbourne, Australia – 15th May 2026
Cell Therapies Pty Ltd (“Cell Therapies”), Australia’s leading contract development and manufacturing organisation (CDMO) for cell and gene therapies, today announced it has entered into a manufacturing agreement with Australian regenerative medicine company Skin2Neuron Pty Ltd (“Skin2Neuron” or “S2N”) to support the manufacture of Skin2Neuron’s lead autologous neurorestorative cell therapy for Phase 1 clinical trials in Australia.
Under the agreement, Cell Therapies will provide process transfer, GMP manufacturing, scale-up and quality release services for Skin2Neuron’s first‑in‑class therapeutic candidate, that is being developed for the treatment of Alzheimer’s disease and other neurodegenerative conditions. Clinical‑grade product manufactured at Cell Therapies’ Melbourne GMP facility will be used in Skin2Neuron’s planned first‑in‑human study.
Skin2Neuron’s technology is based on a proprietary method to isolate and expand hair follicle‑derived neuroprecursor (HFN) cells from a patient’s own skin. These naturally occurring cells are unipotent, gene‑modification free, and capable of differentiating exclusively into neurons. The approach represents a novel therapeutic strategy aimed at replacing neurons lost through Alzheimer’s disease.
“Partnering with Cell Therapies is a major milestone for Skin2Neuron as we transition from pioneering research into the clinical setting,” said Dr Brendon Boot, CEO. Professor Michael Valenzuela, Founder and Chief Scientific Officer of Skin2Neuron added, “Cell Therapies brings deep expertise in GMP manufacturing and clinical translation of complex cell therapies, experience that will be critical as we prepare for a first‑in‑human trial.”
Dr Bev Menner, Chief Executive Officer of Cell Therapies, said the collaboration highlights the growing maturity of Australia’s advanced therapies ecosystem.
“Skin2Neuron’s program represents a truly innovative approach to treating neurodegenerative disease, with the potential to fundamentally change how these conditions are treated,” said Dr Menner. “We are proud to support Skin2Neuron by translating their novel autologous cell therapy into a high‑quality GMP product for clinical trials onshore in Australia.”
The manufacturing program will include technology transfer and scale‑up activities designed to ensure robust, reproducible production of Skin2Neuron’s personalised cell therapy under Australian regulatory standards. The project further reinforces Australia’s position as a preferred destination for early‑phase cell therapy clinical trials, supported by strong regulatory frameworks, world‑class manufacturing infrastructure, and clinical expertise.
Cell Therapies and Skin2Neuron are both members of the Smart Cooperative Research Centre for Health and Wellbeing (SmartCRC), an Australian Government-supported initiative that brings together industry, researchers and end users to develop and commercialise innovative solutions to improve health outcomes.
This agreement adds to Cell Therapies’ growing portfolio of clinical‑stage manufacturing partnerships and underscores its mission to accelerate patient access to advanced cell and gene therapies through high‑quality onshore manufacturing.
About Cell Therapies Pty Ltd
Cell Therapies is Australia’s leading contract development and manufacturing organisation (CDMO) specialising in cell and gene therapies. Operating a state‑of‑the‑art GMP facility in Melbourne, Cell Therapies supports biopharmaceutical companies across process development, GMP manufacturing, quality, and clinical trial supply for advanced therapy medicinal products.
About Skin2Neuron Pty Ltd
Skin2Neuron (S2N) is an Australian regenerative medicine company developing a first‑in‑class autologous neurorestorative cell therapy derived from human hair follicles. The company’s mission is to restore function and quality of life for people living with neurodegenerative diseases, beginning with Alzheimer’s dementia.
Download the full PDF here: CTPL S2N Updated PR 15 05 FINAL
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