Perth, Australia – 17 March 2026 | NeuroScientific Biopharmaceuticals Limited (ASX:NSB) has reached an important development milestone with the commencement of the first technology transfer manufacturing run of its patented StemSmart™ mesenchymal stem cell (MSC) process at leading Australian cell therapy manufacturer Q-Gen Cell Therapeutics.
The initiation of the manufacturing run represents a key step in the transfer of the StemSmart™ manufacturing process to a large-scale clinical contract manufacturer that is then capable of providing adequate supply for Phase 2 clinical trials and future commercialisation.
Q-Gen Cell Therapeutics, located within the QIMR Berghofer Medical Research Institute in Brisbane, is one of Australia’s largest cell therapy contract manufacturers. The facility includes 13 cleanrooms dedicated to cell manufacturing and quality control and holds a Therapeutic Goods Administration (TGA) licence for cell therapy manufacturing, with more than 25 years’ experience supporting industry partners.
The technology transfer program is designed to establish manufacturing capability at clinical scale to support NeuroScientific’s planned Phase 2 clinical trial in Crohn’s disease and future development programs.
NSB Chief Executive Officer, Mr Nathan Smith, commented: “The initiation of the first tech transfer run at Q-Gen is an important step in securing our supply chain for our commercialisation goals. Our partnership with Q-Gen is critical in ensuring patients receive high-quality StemSmart™ products that meet global regulatory standards. Along with our recent successful patient outcomes from the fistulising Crohn’s disease Special Access Program, we are setting the foundation for our upcoming Phase 2 clinical trial.”
NSB Chief Scientific Officer, Dr Marian Sturm, commented: “I am excited by the commencement of the first tech transfer manufacturing run at QGen. It represents a significant milestone and is the culmination of an extensive amount of work by both Q-Gen and NSB. Q-Gen have demonstrated their professionalism, capability and experience in integrating NSB manufacturing technology into their Quality system, sourcing appropriate material suppliers and in implementing the testing platforms. NSB is confident that Q-Gen will successfully complete the technology transfer and manufacture product for our clinical trials.
The technology transfer program involves six stages, including process mapping, documentation transfer, analytical method qualification, GMP engineering and demonstration runs, product comparability assessment and regulatory audit by the TGA.
The current manufacturing run forms part of the GMP engineering and demonstration phase, which requires consecutive compliant batches to be produced and validated against predefined potency and release specifications. Successful completion of this stage will enable formal comparability review and regulatory inspection.
Completion of the full technology transfer program is targeted for the second half of 2026, subject to successful validation and a TGA audit. Following this process, Q-Gen’s manufacturing licence is expected to be expanded to include the StemSmart™ process, allowing clinical-scale supply for Phase 2 trials and beyond.
In parallel with the manufacturing scale-up, NeuroScientific is progressing clinical trial start-up activities including clinical protocol development and regulatory planning for its planned Phase 2 clinical trial in Crohn’s disease, targeted to commence in the second half of 2026.
Crohn’s disease represents a significant and growing global therapeutic market, projected to reach approximately US$13.8 billion by 2026. Despite multiple existing biologic and small-molecule therapies, many patients fail to respond, lose response over time, or experience adverse effects. Patients with refractory or fistulising Crohn’s disease remain particularly difficult to treat, highlighting the need for new therapeutic approaches.
StemSmart™ is designed to modulate pathological immune responses and reduce inflammation. Beyond Crohn’s disease, the technology has potential application across a broader range of immune-mediated inflammatory conditions, including organ transplant rejection, lung inflammatory diseases and graft-versus-host disease.
About us:
About NeuroScientific Biopharmaceuticals Ltd
NeuroScientific Biopharmaceuticals Limited (ASX: NSB) is a biotechnology company focused on the development of novel therapeutics targeting immune-mediated inflammatory disorders. The Company’s research is centred on modulating pathological immune responses involved in chronic and degenerative conditions, particularly where current therapeutic options demonstrate limited efficacy or durability. NSB applies advanced preclinical and translational strategies to support the development of first-in-class or best-in-class biologics addressing significant unmet clinical need.
Targeting Crohn’s Disease with StemSmart™ Technology
Following the acquisition of Isopogen WA Ltd, NSB is prioritizing the application of its proprietary StemSmart technology through a SAS program targeting fistulising Crohn’s disease—a severe and treatment-resistant form of the condition. Favourable outcomes will support the Company’s progression to a Phase 2 clinical trial to further evaluate safety and preliminary efficacy in refractory and/or fistulising Crohn’s disease. This initiative aligns with NSB’s broader strategy to obtain regulatory and reimbursement approval for its MSC therapy both in Australia and internationally, with the goal of making the treatment available to patients with fistulising and refractory Crohn’s disease, for whom current therapies remain inadequate.
About EmtinB™
EmtinB™ is a peptide-based compound that binds to surface-based cell receptors from the LDLR family, activating intracellular signalling pathways that stimulate neuroprotection, neuroregeneration and modulate neuroinflammation. EmtinB™ is modelled on a specific active domain of the complex human protein called Metallothionein-IIA, which is produced as part of the human body’s innate immune response to cell injury. Our preclinical research has established that EmtinB™ is highly specific and selective for its target receptor, safe and well tolerated at high concentrations.
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