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Doug Bright
NeuroScientific Biopharmaceuticals has ticked off another key box on the road to commercialising the company’s StemSmart stem cell therapy, kicking off its first manufacturing run at one of Australia’s leading cell therapy facilities in Brisbane.
The launch marks the start of transferring the company’s already-patented StemSmart production process to Q-Gen Cell Therapeutics, a large clinical-scale contract manufacturer based in the renowned QIMR Berghofer medical research institute.
The institute is a leading independent Australian medical research organisation, housed in the Herston Health Precinct in Brisbane, Queensland. Long-established since 1945, it employs over 700 staff and scientists focused on ground-breaking research in cancer, infectious diseases, mental health, and chronic disorders.
The facility is home to 13 clean rooms dedicated to cell manufacturing and quality control, making it one of the biggest cell therapy manufacturing operations in the country.
For NeuroScientific, the development is a critical milestone. If the technology transfer proves successful, Q-Gen will be able to manufacture StemSmart cell products for upcoming clinical trials and potentially, for future commercial supply.
Management says the transfer process has now entered the engineering and demonstration run stage, which essentially acts as the proving ground for the manufacturing system. During this phase, consecutive batches of StemSmart cells must meet strict quality, potency and release standards before regulators give the green light.
NeuroScientific Biopharmaceuticals chief executive officer Nathan Smith said: “The initiation of the first tech transfer run at Q-Gen is an important step in securing our supply chain for 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.”
The company expects the entire technology transfer program to run through several structured stages, including process mapping, documentation transfer, analytical testing validation and finally, a regulatory inspection by Australia’s Therapeutic Goods Administration (TGA).
Assuming everything runs smoothly, the full transfer is expected to wrap up in the second half of 2026. At that point, the scope of Q-Gen’s manufacturing licence is expected to include the StemSmart production process.
That would then allow the Brisbane facility to produce clinical-scale batches of the therapy to support NeuroScientific’s next major milestone – a phase two clinical trial targeting Crohn’s disease.
Crohn’s disease is a chronic inflammatory condition affecting the digestive tract and represents a significant global market. Management estimates the worldwide Crohn’s disease therapeutics sector could be worth as much as US$13.8 billion (A$19.69 billion) by the end of 2026.
‘The initiation of the first tech transfer run at Q-Gen is an important step in securing our supply chain for commercialisation goals… ’
NeuroScientific Biopharmaceuticals chief executive officer Nathan Smith
Despite a range of drugs already on the market, many lose effectiveness over time, or patients may either fail to respond or experience other side effects. Severe cases, particularly those involving fistulising disease, remain difficult to treat and often leave patients with limited options.
The fistulising complication, which can occur in up to 30 per cent of Crohn’s disease patients, includes chronic and often ulcerating inflammation which creates abnormal tunnels – fistulas – between the bowel, skin or other organs. NeuroScientific believes StemSmart provides a new approach.
The therapy is based on mesenchymal stem cells (MSC) found in tissues and bone marrow. They play crucial roles in regulating abnormal immune responses. By dampening inflammation and providing structural support, the therapy may potentially address the underlying drivers of the disease rather than just treating symptoms.
The company has already begun laying the groundwork for its phase two trial, with clinical protocols and regulatory planning already underway. The trial is currently slated to kick off in the second half of the year and will run in parallel with the scaled-up manufacturing run.
The company has already been buoyed by early patient outcomes from its special access program for fistulising Crohn’s disease (FCD). Under Australia’s Special Access Scheme, patients who have exhausted conventional treatment options can apply for case-by-case access to new and unapproved therapies. Through this pathway, four patients suffering from the debilitating bowel condition were nominated last year by their treating clinicians to receive NeuroScientific’s StemSmart therapy.
The results were impressive. Despite Crohn’s disease often proving severe and notoriously resistant to treatment, three of the four patients achieved a successful clinical response, while the fourth delivered a partial response and continues to show ongoing improvement.
While Crohn’s disease is the company’s immediate focus, NeuroScientific believes the StemSmart platform could ultimately extend well beyond gastrointestinal conditions.
Because the therapy targets immune-driven inflammation, management says it could be applied to a range of other diseases, including transplant rejection, inflammatory lung conditions and graft-versus-host disease.
If that broader potential holds up in clinical studies, StemSmart could evolve from a single-disease therapy into a multi-application platform technology.
For now, the spotlight is firmly on the Brisbane manufacturing run. If NeuroScientific successfully completes the technology transfer and clears the regulatory hurdles ahead, it could establish the industrial horsepower to move StemSmart from the laboratory into late-stage clinical trials and, eventually, into the hands – and bodies – of patients.
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