Isopogen is a public unlisted company developing life-changing cellular medicines. Our patented StemSmart™ technology improves the clinical efficacy of Mesenchymal Stem Cells (MSC), offering a powerful competitive advantage against other MSC products.
Our proprietary cellular medicines made using the StemSmart™ technology are in late-stage clinical development to treat several auto-immune conditions including Crohn’s Disease, Graft-versus-Host Disease (GvHD) and various lung diseases.
StemSmart’s patented manufacturing process
Derived from donor bone marrow, mesenchymal stem cells (MSCs) are isolated and grown, before applying the patented StemSmart™ technology to improve the cells’ clinical efficacy. This manufacturing is completed under a Therapeutic Goods Administration (TGA) license in accordance with Good Manufacturing Practice (GMP). The resulting proprietary cellular medicine is a non-invasive, universal treatment (does not require patient tissue matching) that can be frozen until use.
By moderating the patient’s immune system and supporting tissue regeneration, these products can be a life-changing treatment for patients suffering from some of the most debilitating inflammatory and auto-immune conditions.
StemSmartTM MSC is a platform technology that has been used in 11 clinical phase 1 & 2 trials/studies undertaken in Australia with 170 patients safely treated and >1,200 infusions. These results have been widely published, including an impressive 78% clinical response and 53% clinical remission in life-threatening (refractory) Crohn’s patients (Phase II study), making the StemSmart™-created product the only MSC treatment has clinically proven to treat this condition.
Led by internationally renowned cellular scientist Dr Marian Sturm, in FY21 Isopogen will work to submit its product application for life-threatening Crohn’s to Australia’s TGA. If successful, this will ensure wider distribution of this life-changing treatment and will provide a foundation for international licensing opportunities – potentially helping Crohn’s sufferers globally.
Coupled with its patented StemSmart™ manufacturing technology that can be licensed to MSC manufacturers globally, Isopogen aims to maximize the benefits of cellular therapies to patients worldwide.
Isopogen has received patent approval (expiring on 3 November 2034) for its StemSmart technology in Australia, the US, South Africa, Japan, Israel, and Singapore and pending approval in Canada, China, Europe, Korea, Hong Kong, and Brazil.