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ORBSEN THERAPEUTICS HAS DEVELOPED A NOVEL METHOD FOR ISOLATING AND PURIFYING
MESENCHYMAL STROMAL CELLS (MSC) FOR USE IN HUMAN THERAPY

Orbsen has developed transformative technologies that deliver highly purified mesenchymal stromal cells (MSC), isolated from either human bone marrow (ORBCEL-M) or from human umbilical cord (ORBCEL-C). Our work is advancing understanding of the bio-distribution and mechanism of action of stromal cell therapies.

Orbsen has identified a marker protein as a tool for selecting therapeutic stromal stem cells from the mixture of cells residing in the bone marrow, umbilical cord, or fat tissue. Antibodies to this marker recognize a protein on the stromal cells’ surface and enables the isolation of a clearly defined population of nearly 100 percent pure stromal cells from the tissue of human donors. These selected cells can be expanded in culture to form many therapeutic doses and can be used allogeneically in patients (i.e. one donor, multiple unrelated recipients). ORBCEL MSCs release a series of factors which can produce an anti-inflammatory response, induce blood vessel formation, improve bone and cartilage growth and can demonstrate an immunomodulatory effect.

Our proprietary technology is approximately 3,000 times more precise at isolating and harvesting MSC than the current methods–employed by most stem cell developers–that rely on cell adherence to plastic cell culture dishes. Using our proprietary selection and expansion process, we have achieved the highest levels of MSC purity in the world.

“[Orbsen] has overcome one of the most signigicant challenges facing the developers of stem cell therapies–the purity of the cells being administered to the patient.”

–The Irish Times

Recently, Orbsen Chief Scientific Officer, Dr. Stephen Elliman, was interviewed by Kieran Ryan from REMEDI, about his work developing Orbsen’s novel stromal cell technology. In this video clip, Steve explains the therapeutic significance of  mesenchymal stromal cells (MSC), how forthcoming regulation will impact stromal cell therapies and how Orbsen has set the benchmark for the industry by defining and purifying MSCs.

Advancing Regenerative Medicine

Orbsen’s approach to ORBCEL™ development has been to combine internal testing with rigorous independent validation of the technology. Within the European Union Framework 7 (EU FP7) funded REDDSTAR and MERLIN programs, the ORBCEL™ product was tested head-to-head against the traditional plastic adherent (PA) cells in eight different pre-clinical animal models across eight different research centers. Orbsen’s product demonstrated an equivalent or better therapeutic response in models of five diabetic complications (nephropathy, neuropathy, retinopathy, cardiomyopathy and wound healing); acute respiratory distress syndrome (ARDS); rheumatoid arthritis and inflammatory liver disease. This validation approach has led to rapid progression of ORBCEL™ from a discovery and pre-clinical phase to four EU FP7 funded clinical programs within just three years. ORBCEL™ will have completed four early phase clinical studies and will be ready for Phase 3 pivotal testing within several years.

Intellectual Property: Orbsen’s initial patent application was filed in 2012 and was granted by the EPO in 2015, providing 17 years of commercial protection to 2032. Our intellectual property covers Orbsen’s cellular therapy compositions, efficient processes for their extraction, purification, manufacturing scale-up and the broad range of applications for which they are being developed in key markets including the United States, Canada, Europe, Australia, Japan, Russia, India and China.

Focused Pipeline: Orbsen is developing a range of products derived from the Company’s proprietary ORBCEL™ technology platforms with pre-clinical and early-stage trials in its core therapeutic areas: Diabetic vascular complications where ORBCEL™ products are being developed for both local and systemic application; and acute inflammatory and autoimmune diseases with an underlying inflammatory and immunologic etiology, which may be addressed by intravenous delivery of cell therapy for immunomodulation.

We are working on the development of an extensive range of therapies based on our proprietary technologies. The targets for these therapies include:

ARDS is a devastating critical care syndrome characterized by pulmonary oedema, respiratory failure and multiple organ failure. Sepsis and pneumonia are the most common causes of ARDS and lead to the worst outcome. Mortality rates approach 40% at 28 days. ARDS represents a major burden to critical care and annually affects approximately 400,000 – 500,000 patients in Europe, the United States and Japan alone. There are no currently approved or effective pharmacological therapies for ARDS. A single dose of ORBCEL™ has been demonstrated to significantly improve lung oxygenation, reduce inflammation, reduce oedema and reduce bacterial infection in a series of pre-clinical experiments. ORBCEL™ will be tested for safety, feasibility and efficacy in the Phase 1/2 REALIST clinical trial.
Non-healing neuropathic foot ulcers in patients with diabetes develop due to distal sensory loss. The current standard care involves (i) removal of pressure from the ulcer, (ii) restoration of blood flow if peripheral vascular disease is present, (iii) debridement of the ulcer, and (iv) antibiotic therapy to control infection. On average, standard care results in only 30% healing after 20 weeks of treatment, therefore there is a critical clinical need to develop novel therapies for treatment of non-healing diabetic ulcers in order to prevent amputation and reduce the significant drain on healthcare budgets and burden on an individual’s health. In pre-clinical models of non-healing diabetic wounds, a single topical application of ORBCEL™ in a collagen matrix significantly improved wound closure. The safety/feasibility of topical ORBCEL™ will be assessed in the REDDSTAR Phase 1b clinical trial.
Diabetic nephropathy (also known as diabetic kidney disease) is a progressive disease caused by damage to the blood vessels in the kidney and is associated with long term, uncontrolled diabetes. The disease is characterized by failure of the kidney to filter out protein which leads to scarring of the glomeruli. DKD is the prime reason for dialysis and kidney transplantation in many developed countries. Patients usually succumb to associated cardiovascular disease, or progress to end stage renal disease which has a mortality rate similar to many cancers. There have been no new therapies approved for DKD in the last 20 years. In preclinical chronic models of DKD, a single dose of ORBCEL™ significantly improved the filtration rate of the kidney whilst reducing damage to the glomeruli, reducing proteinuria and inflammation. The safety, feasibility and efficacy of ORBCEL™ will be assessed in the NEPHSTROM Phase 1/2 clinical trial.
Primary Sclerosing Cholangitis is a chronic immune mediated liver injury of unknown cause, with a natural history of progression to liver failure. PSC does not respond to classic immunosuppressants and there are no current therapies. PSC have been observed in all heritages and accounts for more than 10% of all liver transplants. In three distinct models of inflammatory liver injury, a single dose of ORBCEL™ improves liver function and reduces inflammation. The safety, feasibility and preliminary efficacy of ORBCEL™ will be assessed in the MERLIN Phase 1/2 clinical trial.
Sepsis is a life-threatening condition arising from an infection leading to systemic inflammation and multi-organ failure. Sepsis is a leading cause of mortality worldwide, affecting more than 15 million people each year. Mortality rates approach 50% for severe sepsis and up to 80% for septic shock. Sepsis is implicated as a factor in up to 50% of all in-hospital deaths. There is no current treatment for sepsis. Orbsen is currently evaluating the efficacy of ORBCEL™ in multiple models of sepsis.