Latest news with #Isopogen
West Australian
15 hours ago
- Health
- West Australian
New dawn for NeuroScientific with stem cell acquisition
Stem cell therapies have long promised to press the body's reset button - potentially reversing injuries and damage from disease, regenerating tissue and reshaping modern medicine. For ASX-listed NeuroScientific Biopharmaceuticals, that promise starts now thanks to its $5.1 million acquisition of unlisted Perth-based stem cell therapy company Isopogen. The deal will hand NeuroScientific the keys to Isopogen's patented 'StemSmart' technology, which innovatively prepares a specific type of stem cell, mesenchymal stem cells (MSC), for use as an intravenous infusion. MSC are universal donor cells, meaning that there is no need for matching between a donor and recipient. The are effectively an 'off-the shelf' cell therapy. Over the past 20 years, haematology medical scientist Dr Marian Sturm, NeuroScientific's incoming chief scientific officer, pioneered the development of MSCs in her former role as facility director of Royal Perth Hospital's Cell and Tissue Therapies centre. The cells have so far been used in many patients, including as a last-line treatment for critically ill patients suffering severe immune complications from bone marrow transplantation and in kidney and lung transplant rejection, through early phase clinical trials and studies and on compassionate grounds, with promising results. The MSC technology has also been employed to treat patients with severe Crohn's disease, an inflammatory autoimmune condition that affects the gut. The disease can develop into very difficult-to-manage and treat forms, including refractory Crohn's, in which patients experience persistent uncontrolled flare-ups, and fistulising Crohn's, in which patients develop an open wound from a gut flare-up out to the skin. In a phase two trial targeting refractory Crohn's disease, a condition that no longer responds to standard treatments, of 18 patients treated with StemSmart MSC, 78 per cent of patients experienced clinical improvement and 44 per cent achieved full remission. That level of efficacy is considered impressive in the MSC field, particularly for refractory Crohn's. With the global market for refractory Crohn's treatment alone estimated to be worth about US$7.5 billion, it's no wonder StemSmart's new owner quickly hailed the system as a potential game-changer. StemSmart technology offers a step up from traditional MSC manufacturing in that the cells are grown in a special media, becoming activated in the process. The platform technology was developed at Royal Perth Hospital (RPH) and manufactured using RPH's processes. Notably, the manufacturing methodology can yield more than 200 cryopreserved clinical doses from just 10 millilitres of precious donated bone marrow, giving it both clinical flexibility and manufacturing scale. Based on the early results in Crohn's disease and in other conditions, Sturm now sees hope in employing MSCs to treat other autoimmune and inflammatory diseases, possibly including lupus, multiple sclerosis and rheumatoid arthritis. As the cells can grow into skin, bone, fat and other tissue cells, they also offer potential applications for tissue repair, such as bone repair for skull or long bone injuries, for example. The clinical development of MSC stretches back to 2002, when a Swedish paediatric haematologist used MSCs for the first time to treat a child gravely ill with complications from the treatment of leukaemia. The cells were isolated and grown in the doctor's laboratory from bone marrow donated by the child's mother. The child's clinical response to the cells was striking. No doubt, the successful experimental treatment would have caught the attention of immunology and haematology researchers and clinicians worldwide, including Sturm, an expert in blood, cell and tissue transplant manufacturing for clinical applications, who was the then-director of RPH's cutting-edge Cell and Tissue Therapy facility. At the time, Sturm was particularly focused on delivering MSCs as safely as possible into healthcare areas of unmet need. She began experimenting with ways to process the cells into a safe infusion that could be used to treat diseases and transplant complications where there were few or no existing clinical options. In 2007, Dr Sturm was approached by her clinical colleagues, who wanted to use the MSC product on compassionate grounds to treat a critically ill man with complications of bone marrow transplant to treat blood cancer. At the time, about 60 per cent of bone marrow transplant patients, who received donor marrow, developed a serious complication, known as graft-versus-host disease (GVHD), where the new blood system created by the bone marrow transplant rejects the recipient's body. It usually presents with symptoms that affect the gut, skin and liver, and is treated with steroids. With recent advancements in transplant practices, the incidence of acute GVHD has fallen to now occurring in about 25-30 per cent of cases. However, these medicines fail in about 30 per cent of acute GVHD cases – and most of this group die. After receiving MSC treatment, the man quickly recovered, spurring Sturm to keep working to develop a scalable, commercial-grade MSC product and patenting the manufacturing process. After an agreement was reached between Isopogen and the State Government's East Metropolitan Health Service (EMHS) giving Isopogen control of the MSC technology, NeuroScientific struck a deal with Isopogen to progress StemSmart. The all-scrip acquisition sees Isopogen shareholders receive 85.7 million NeuroScientific shares and 57.1 million performance shares tied to future clinical and commercial milestones. The market welcomed the move, with NeuroScientific's share price surging 97 per cent on the day of the announcement. A $3.5 million capital raise led by Perth corporate advisor Westar Capital, after existing funds, creates a war chest of about $7.5 million. This will support further development, including for a special access program or bigger phase 2/3 trials for patients with refractory and fistulising Crohn's, and will enable regulatory engagement with Australia's Therapeutic Goods Administration with a long-term goal of partial or full registration for StemSmart MSC, first up as a Crohn's treatment. The company is also eyeing the United States, where inflammatory bowel disease is forecast to grow into a lucrative US$13.8 billion market by 2026. About 30 per cent of Crohn's patients fail to respond to current gold-standard treatments, such as biologics, making them prime candidates for a new approach, such as StemSmart. The takeover signals a bold pivot for NeuroScientific, which previously focused on peptide-based drugs for neurodegenerative diseases such as Alzheimer's. Those drugs showed promise, but the timelines to market were long. By contrast, StemSmart's progress and results over decades of development position the product closer to near-term commercialisation, helped along by NeuroScientific's healthy bank balance. Nor will NeuroScientific be walking away from its roots completely. Two current directors will remain on the company's revamped board, and management will explore crossover applications for StemSmart, particularly to tackle the neuroinflammation that is a hallmark of inflammatory diseases such as Alzheimer's. That convergence could open a dual-front therapeutic pipeline, leveraging both peptide and cellular approaches. While competition in the stem cell space is fierce, the upside is enormous. Importantly, the US Food and Drug Administration (FDA) recently approved the first mesenchymal stromal cell therapy by ASX-listed, regenerative medicine company Mesoblast. While MSC products have been approved in other jurisdictions, the FDA approval of an allogeneic, bone marrow-derived MSC product for paediatric, steroid-refractory, acute graft-versus-host disease is momentous. According to NeuroScientific, StemSmart is differentiated by its purity, potency and consistency. In preclinical and early human data, the platform has shown enhanced potency over conventional MSCs. The recent regulatory FDA approval of MSC also tilt the momentum in StemSmart's favour, suggesting regulators are warming to well-characterised stem cell platforms with rigorous clinical data. Is your ASX-listed company doing something interesting? Contact:
The Age
15 hours ago
- Health
- The Age
New dawn for NeuroScientific with stem cell acquisition
Stem cell therapies have long promised to press the body's reset button - potentially reversing injuries and damage from disease, regenerating tissue and reshaping modern medicine. For ASX-listed NeuroScientific Biopharmaceuticals, that promise starts now thanks to its $5.1 million acquisition of unlisted Perth-based stem cell therapy company Isopogen. The deal will hand NeuroScientific the keys to Isopogen's patented 'StemSmart' technology, which innovatively prepares a specific type of stem cell, mesenchymal stem cells (MSC), for use as an intravenous infusion. MSC are universal donor cells, meaning that there is no need for matching between a donor and recipient. They are effectively an 'off-the shelf' cell therapy. Over the past 20 years, haematology medical scientist Dr Marian Sturm, NeuroScientific's incoming chief scientific officer, pioneered the development of MSCs in her former role as facility director of Royal Perth Hospital's Cell and Tissue Therapies centre. The cells have so far been used in many patients, including as a last-line treatment for critically ill patients suffering severe immune complications from bone marrow transplantation and in kidney and lung transplant rejection, through early phase clinical trials and studies and on compassionate grounds, with promising results. The MSC technology has also been employed to treat patients with severe Crohn's disease, an inflammatory autoimmune condition that affects the gut. The disease can develop into very difficult-to-manage and treat forms, including refractory Crohn's, in which patients experience persistent uncontrolled flare-ups, and fistulising Crohn's, in which patients develop an open wound from a gut flare-up out to the skin. 'NSB's acquisition of Isopogen will allow our StemSmart technology to be progressed for the benefit of vulnerable patients with limited treatment options.' NeuroScientific Biopharmaceuticals incoming chairman Robert McKenzie In a phase two trial targeting refractory Crohn's disease, a condition that no longer responds to standard treatments, of 18 patients treated with StemSmart MSC, 78 per cent of patients experienced clinical improvement and 44 per cent achieved full remission. That level of efficacy is considered impressive in the MSC field, particularly for refractory Crohn's. With the global market for refractory Crohn's treatment alone estimated to be worth about US$7.5 billion, it's no wonder StemSmart's new owner quickly hailed the system as a potential game-changer. StemSmart technology offers a step up from traditional MSC manufacturing in that the cells are grown in a special media, becoming activated in the process. The platform technology was developed at Royal Perth Hospital (RPH) and manufactured using RPH's processes.
Sydney Morning Herald
15 hours ago
- Health
- Sydney Morning Herald
New dawn for NeuroScientific with stem cell acquisition
Stem cell therapies have long promised to press the body's reset button - potentially reversing injuries and damage from disease, regenerating tissue and reshaping modern medicine. For ASX-listed NeuroScientific Biopharmaceuticals, that promise starts now thanks to its $5.1 million acquisition of unlisted Perth-based stem cell therapy company Isopogen. The deal will hand NeuroScientific the keys to Isopogen's patented 'StemSmart' technology, which innovatively prepares a specific type of stem cell, mesenchymal stem cells (MSC), for use as an intravenous infusion. MSC are universal donor cells, meaning that there is no need for matching between a donor and recipient. They are effectively an 'off-the shelf' cell therapy. Over the past 20 years, haematology medical scientist Dr Marian Sturm, NeuroScientific's incoming chief scientific officer, pioneered the development of MSCs in her former role as facility director of Royal Perth Hospital's Cell and Tissue Therapies centre. The cells have so far been used in many patients, including as a last-line treatment for critically ill patients suffering severe immune complications from bone marrow transplantation and in kidney and lung transplant rejection, through early phase clinical trials and studies and on compassionate grounds, with promising results. The MSC technology has also been employed to treat patients with severe Crohn's disease, an inflammatory autoimmune condition that affects the gut. The disease can develop into very difficult-to-manage and treat forms, including refractory Crohn's, in which patients experience persistent uncontrolled flare-ups, and fistulising Crohn's, in which patients develop an open wound from a gut flare-up out to the skin. 'NSB's acquisition of Isopogen will allow our StemSmart technology to be progressed for the benefit of vulnerable patients with limited treatment options.' NeuroScientific Biopharmaceuticals incoming chairman Robert McKenzie In a phase two trial targeting refractory Crohn's disease, a condition that no longer responds to standard treatments, of 18 patients treated with StemSmart MSC, 78 per cent of patients experienced clinical improvement and 44 per cent achieved full remission. That level of efficacy is considered impressive in the MSC field, particularly for refractory Crohn's. With the global market for refractory Crohn's treatment alone estimated to be worth about US$7.5 billion, it's no wonder StemSmart's new owner quickly hailed the system as a potential game-changer. StemSmart technology offers a step up from traditional MSC manufacturing in that the cells are grown in a special media, becoming activated in the process. The platform technology was developed at Royal Perth Hospital (RPH) and manufactured using RPH's processes.
News.com.au
19-05-2025
- Business
- News.com.au
Dr Boreham's Crucible: Can this biotech emerge from Mesoblast's shadow and ride ‘stem cells 2.0'?
Investors now have three ASX-listed stem cell therapy companies to choose from – and we can thank sector big daddy Mesoblast for inspiring the third. Hitherto a developer of peptide-based drugs for neuroscientific conditions, NeuroScientific Biopharmaceuticals (ASX:NSB) s is in the process of acquiring Stemsmart, the stem-cell portfolio of the public unlisted Western Australia company Isopogen WA Ltd. In December, Mesoblast won US Food and Drug Administration (FDA) approval for Ryoncil, its stem cell treatment for paediatric graft versus host disease (GvHD). Neuroscientific describes this approval as 'momentous', as it was the first FDA assent for a therapy derived from donor bone marrow. Both the Ryoncil and Stemsmart therapies are based on mesenchymal stromal cells (MSCs). (The other company is Cynata, also working with mesenchymal stem cells but induced pluripotent ones called IPSCs.) 'Stem cell therapy is a cornerstone of modern medicine,' the company says. 'Stem cells have the unique ability to develop into different cell types in the body and are often hailed as the body's master cells.' Neuroscientific's initial focus is on the common auto-immune condition Crohn's disease. That makes sense, given Isopogen underwent a phase II trial for that condition that deemed the therapy to be 'potent, efficacious and safe.' About Neuroscientific To date, the Perth-based Neuroscientific has been developing peptide-based drugs for several neuro-degenerative conditions with high unmet medical demand. Neuroscientific was founded by former equities analyst Dr Anton Uvarov, on the back of the Emtinb peptide. This asset was developed by the University of Copenhagen and then acquired by the University of Tasmania. The company listed on July 25, 2018, having raised $6 million at 20 cents apiece. At the time, Emtinb was most advanced for Alzheimer's disease, but recently the board decided to focus on glaucoma. Before founding the company, Uvarov had a two-year stint a biotech analyst at Citigroup. He has also been on the board of several ASX listed biotechnology companies and non-biotechs, including Blinklab, Actinogen, Sun Biomedical (now Dimerix), Acuvax and Imugene. The company's portfolio includes Emtinb (initially targeting glaucoma) and Emtinac, Emtinan, and Emtinbn 'which have demonstrated similar therapeutic potential as Emtinb'. As part of the Stemsmart purchase, current Isopogen directors Robert McKenzie and Paul Fry will join the board. The force behind Stemsmart, Dr Marian Sturm joins as chief scientific adviser. An inaugural member of the local Therapeutical Goods Administration (TGA) advisory committee on biologics – among other things – Sturm is a leading expert in cell therapies in Australia (particularly in stem cell therapies). Peace deal: now for Ukraine and Gaza Uvarov says he had known about Sturm and her work for some time, given they both hail from Perth medical circles. In 2021, Perth's East Metropolitan Health Service (EMHS) launched a legal action over ownership of the stem cell intellectual property on which Isopogen was founded. Sturm was a long-time employee of EMHS's Royal Perth Hospital. The technology was developed in 2007 and registered in Sturm's and Isopogen's names. Neuroscientific swooped after Sturm and EMHS last year reached a 'mutually acceptable' confidential settlement. A joint statement said the peace deal provided the basis for an 'ongoing relationship' – so let's call it friends with benefits. Investors had been excited about Isopogen's prospects as a 'mini Mesoblast' – and an ASX listing seemed on the cards. But the prolonged and increasingly complex legal spat put paid to that. 'As soon as it was resolved we jumped on the opportunity,' Uvarov says. About Stemsmart Neuroscientific describes the Stemsmart cells as having 'potent anti-inflammatory and immune-modulatory properties'. This creates a 'multifaceted and complex interaction' with the body's immune system, dampening inflammation, moderating immune responses and encouraging tissue repair. 'It's quite an advanced program,' Uvarov says. 'Overall, more than 200 patients have gone through this therapy, so we know it's quite safe and active.' Derived from adult human donor marrow, mesenchymal stem cells (MSCs) are grown in a culture and then revved up with the patented cell manufacturing process. To date, patients have received Stemsmart on compassionate grounds for a variety of serious and life-threatening clinical conditions, with 'multiple strong positive clinical responses'. Crohn's disease Isopogen undertook a phase II trial of 18 patients with refractory Crohn's disease. The results were 'promising', with most patients experiencing clinical improvement and even clinical remission. The company's attention has turned to a small, 12-person, phase I trial for fistulating Crohn's disease under a TGA special access program. A severe complication of Crohn's disease, fistulas are abnormal tracts connecting the intestine to another organ or to the external surface of the body. Fistulating Crohn's disease is challenging to treat and sustained healing with standard therapies has been limited. 'Nothing disease modifying exists now, so it's a massive market,' Uvarov says. 'If we do a phase I trial, the next step would be to move to a phase II/III study as a potential step towards a regulatory trial.' The study will aim for a closure of more than 50% of the fistula openings, or a decrease in fistula discharge of more than 50% in at least four patients. Addressable markets Over the next 24 months, the company envisages expanding its stem cells trial from Crohn's disease, to other inflammatory and immune-based disorders including lung disorders and acute kidney transplant rejection. Uvarov says Isopogen has 140 doses frozen and ready for use in further clinical studies. Several patients have received the therapy on compassionate grounds, including both children and adult with graft versus host disease (GvHD). The company cites a US$13.8 billion addressable market for Crohn's disease and a US$640 million opportunity for GvHD by 2026. There's a projected US$7.2 billion market for organ transplant immune-suppressants by 2030 - the majority for renal – and a forecast US$33 billion market for lung disorders by 2023. Legacy program lives on And let's not forget about Neuroscientific's pre-clinical legacy program. Emtinb targets Alzheimer's disease and advanced glaucoma. In 2023, Neuroscientific decided development should focus on the latter as a therapy administered locally, via intravitreal injection. Uvarov says the company moved to stem cells because the legacy program was not moving as fast as investors would have liked. And an Alzheimer's program would have required a much bigger trial. In June last year, the company met with the US Food and Drug Administration for a pre-investigational drug approval powwow, with the agency guiding on the pre-clinical studies required to progress Emtinb to a first-in-human trial. Based on this counsel, the company plans a pharmaco-kinetics rabbit study, by which Emtinb is intravitreally administered. In parallel, the company plans a 13-week study of 'ocular tolerance, systemic toxicity and pharmacokinetic following repeated intravitreal administration in pigmented rabbits'. Given there's shortage of animals for medical research as suppliers withdraw from the market, it's a case of when the company can obtain the specially bred bunnies. 'It's harder to do animal studies because of regulatory pressure,' Uvarov says. 'Regulators want to move from pre-clinical animal studies to cell-based research using animal organoids.' Organoids are three-dimensional structures that mimic the architecture and function of human organs and tissues. Finances and performance Neuroscientific must obtain the separate assent from all Isopogen holders, although Sturm is by far the biggest holder. The company has snared 51.4% of Isopogen holders and is confident of the remaining minority holders coming on board. Under the scrip deal, Isopogen holders receive 85,714,286 shares, deemed to be worth 3.5 cents. At today's values the deal is worth a tad over $4 million. Isopogen holders also receive 57,142,857 performance shares convertible to ordinary shares, subject to the aforementioned milestones. These must be achieved within three years of a shareholder meeting to approve the performance shares, scheduled for mid-June. All the issued shares will be escrowed for 12 months. Currently underway, the $3.5 million capital raising is by way of a placement of 100 million shares, at 3.5 cents a share. Post-raising, the company will have cash of $7.5 million. Of the funds raised, just over $2 million is expected to be used for Stemsmart-related stuff. A further $835,000 is earmarked for the Emtinb program. Over the last 12 months Neuroscientific shares have ranged between 3.3 cents (early January this year) and 5.5 cents (early May 2024). The stock peaked at 50 cents in mid-September 2021. The tightly held register is dominated by the Clough family office, of Clough Engineering fame. Clients of Westar Capital account for much of the remainder. Dr Boreham's diagnosis Uvarov says Isopogen's stem cells could be 'even more potent' than Mesoblast's cells, although they work more by way of immune modulation rather than regeneration. 'Our cells … have more growth factors they excrete when you culture them,' he says. He says the FDA's approval of Mesoblast's Ryoncil 'paves the way for renewed enthusiasm and global investment in clinical research of MSC therapies'. It's not just the company that's hyper-enthused: the International Society for Cell and Gene Therapy dubs the Ryoncil approval as 'a pivotal moment in the history of medicine shaping the future of therapeutics'. Uvarov adds that after years of being untrendy, stem cells again were the hot topic at JP Morgan's global biotech gabfest in January. 'We are at the beginning of stem cells 2.0,' he says. Given Mesoblast is worth around $2.3 billion and Neuroscientific is valued at not much more than its cash backing, Neuroscientific will be walking in the shadow of a giant. 'When Mesoblast was at a similar stage they had a market cap of several hundred million dollars,' Uvarov says. How soon the company emerges from this penumbra depends on the pace of its trials and – ultimately – its first port of call of initial TGA approval. 'It's complex and tricky so we are taking it slow,' Uvarov says. At a glance: ASX Code: NSB Share price: 4.8 cents Shares on issue: 144,604,870 * * Increases to 333,176,299 shares post-Isopogen WA acquisition and placement Market cap: $6.9 million Chief executive officer: Dr Anton Uvarov (founder) Board: Chris Ntoumenopoulos (chair), Dr Tony Keating, Clarke Barlow, Uvarov, Dr Linda Friedland Financials (March quarter 2025): revenue nil, cash burn $182,000, cash of $4.3 million (ahead of $3.5 million capital raising).
