Perth-based stem cell therapy pioneer NeuroScientific Biopharmaceuticals has started transferring its patented StemSmart process to one of Australia’s biggest and most experienced cell therapy manufacturers to scale up clinical-grade production.
Queensland-based Q-Gen Cell Therapeutics will take over the manufacturing of StemSmart’s specific mesenchymal stromal stem cells (MSC) from Royal Perth Hospital’s Cell and Tissue Centre.
NeuroScientific says the technology transfer will allow it to establish MSC manufacturing for its StemSmart infusions for further clinical trials and pursue commercial opportunities.
The MSC technology was developed as a last-line infusion treatment for critically ill patients, including those experiencing severe immune complications from bone marrow transplants, kidney and lung transplant rejection and inflammatory Crohn’s disease.
NeuroScientific acquired the StemSmart technology in late June via its $4.1 million acquisition of unlisted Perth-based stem cell company Isopogen. Isopogen had previously signed a manufacturing contract with QIMR Berghofer, under which Q-Gen undertook manufacturing process development to scale up clinical-grade production of the StemSmart platform.
Q-Gen, located in QIMR in Brisbane, has more than 25 years of experience in cell therapy manufacturing for industry. The laboratory specialises in manufacturing cellular immunotherapies for national and international clinical trials from 13 cleanrooms dedicated to cell manufacturing and quality control.
NeuroScientific Biopharmaceuticals chief executive officer Nathan Smith said: “We are very pleased to be partnering with Q-Gen given their extensive experience in manufacturing, process development and GMP production of biologic products for clinical trials. This relationship will allow the company to scale the manufacturing of its StemSmart technology to address substantial market opportunities.”
StemSmart offers a step up from traditional MSC manufacturing in that the cells are grown in a special medium, becoming activated in the process. The platform technology was developed at Royal Perth Hospital and manufactured using the hospital’s processes.
The cells have been used many times over the years via early-phase clinical trials, studies and on compassionate grounds, with promising results.
Later in the year, NeuroScientific expects to receive the interim results from its latest compassionate access program involving patients with difficult-to-treat fistulising Crohn’s disease, in which an open wound develops from a gut flare-up that extends out to the skin.
A successful clinical outcome will help the company validate its proprietary StemSmart technology in this patient group, which otherwise has limited treatment options.
NeuroScientific is fast building towards regulatory approvals and commercialisation for StemSmart. This month, it announced two heavy-hitting appointments. The company has appointed Melbourne-based Smith’s as its chief executive officer and well-regarded Perth-based paediatric haematologist and oncologist Dr Catherine Cole as its chief medical officer.
Smith has extensive experience in cell and gene therapies in senior commercial, operational and strategic roles in Australia and the United States, which should prove invaluable as the company navigates the regulatory and commercial pathways for its innovative StemSmart technology.
The company says Smith’s deep expertise in good manufacturing practice (GMP) will be critical for converting the biotechnology startup into a scaled-up commercial stem cell company.
Cole has held clinical and academic leadership roles across Australia and overseas, including head of haematology and oncology at Perth Children’s Hospital and professor of paediatric haematology and oncology at The University of Western Australia.
She is also the former director of stem cell transplantation at Perth Children’s Hospital, placing her front and centre in NeuroScientific’s race to employ stem cell therapy to treat some of the most debilitating transplant complications and autoimmune diseases.
The high-level executive duo join a strong leadership team, which also includes Perth-based haematology medical scientist Dr Marian Sturm as NeuroScientific’s chief scientific officer. Sturm pioneered the use of the MSC used in StemSmart over the past 20 years in her former role as facility director of Royal Perth Hospital’s Cell and Tissue Therapies centre.
While competition in the stem cell space is fierce, the upside is enormous. StemSmart’s progress and results over decades of development position the product closer to near-term commercialisation than some others also in the pipeline, which will be helped along by NeuroScientific’s healthy bank balance.
A $3.5 million capital raise handed the company a $7.5 million war chest to support further trials and development and help it generate plenty of momentum towards its long-term goal of partial or full registration for StemSmart, first up as a Crohn’s treatment.
NeuroScientific’s progress in the field of stem cell therapy has certainly got the tongues wagging recently. The soaring share price has hardly taken a breather, clocking in with an eye-watering 360 per cent rise to 23.5 cent a share in the last two months alone.
As StemSmart edges closer to regulatory approval and potential commercial rollout starts to take shape - starting with the pressing need in Crohn’s disease - NeuroScientific appears poised to carve out a meaningful niche in the high-stakes world of advanced cell therapies.
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By James Pearson
