CEO Nathan Smith says the tech transfer secures the supply chain for commercialisation and backs upcoming Phase 2 Crohn’s trials following encouraging Special Access Program results.

A Phase 2 trial for Crohn’s disease is planned to begin in the second half of 2026, running in parallel with the scaled-up manufacturing run.

StemSmart is based on mesenchymal stem cells aimed at dampening inflammation and addressing core disease drivers, with potential applications beyond Crohn’s disease, including transplant rejection and inflammatory lung conditions, positioning it as a multi-application platform.

The transfer process currently sits in the engineering and demonstration phase, where successive StemSmart batches must meet strict quality, potency, and release standards before regulatory approval.

NeuroScientific Biopharmaceuticals has begun its first manufacturing run for StemSmart at Q-Gen Cell Therapeutics in Brisbane, transferring production to the large contract manufacturing facility at the QIMR Berghofer institute to enable clinical-scale output.

The Crohn’s disease market remains a major focus, with a potential global value of about US$13.8 billion (A$19.69 billion) by end-2026, underscoring the therapy’s commercial appeal.

The technology transfer will progress through stages—process mapping, documentation transfer, analytical testing validation, and a regulatory inspection by the Therapeutic Goods Administration—targeting completion in the second half of 2026.

Early results from Australia’s Special Access Program for fistulising Crohn’s disease show three of four patients with a successful clinical response and another with a partial, improving response, supporting StemSmart’s potential.

The full technology transfer is expected to complete in the second half of 2026, after which Q-Gen’s manufacturing licence would cover StemSmart production for NeuroScientific.

In summary, the move to Q-Gen at QIMR Berghofer marks a milestone toward commercial production and future supply for StemSmart as clinical data build toward Phase 2 trials.