ORBSEN THERAPEUTICS HAS DEVELOPED A NOVEL METHOD FOR ISOLATING AND PURIFYING ALLOGENEIC STROMAL CELLS (ASC) FOR USE IN HUMAN THERAPY
Orbsen has developed transformative technologies that deliver highly purified stromal cells 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 immunotherapies.
Orbsen has identified a marker protein as a tool for selecting therapeutic stromal 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 that reduce inflammatory responses, enable blood vessel formation and can demonstrate an immunomodulatory effect.
“[Orbsen] has overcome one of the most significant challenges facing the developers of stem cell therapies-the purity of the cells being administered to the patient.” -The Irish Times
Our proprietary technology is approximately 3,000 times more precise at isolating and harvesting stromal cell than the current methods-employed by most stem cell developers – who 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.
Dr. Larry Couture
Orbsen Therapeutics recently presented at the annual Stem Cells on the Mesa meeting in San Diego. The meeting was organized by the Alliance for Regenerative Medicine, of which Orbsen Therapeutics is member and contributor on topics such as regulatory affairs and cell therapy research and development. In his talk, Dr. Couture provides an overview of the Orbsen technology, pre-clinical science and clinical development plans.
Dr. Stephen Elliman
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 Immunotherapies
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 and Horizon 2020(EU FP7 and H2020) 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 four diabetic complications (nephropathy, neuropathy, retinopathy 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 funded clinical programs within just three years. ORBCEL™ will have completed four early phase clinical studies and will be ready for pivotal clinical testing by 2021.
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; acute inflammatory and autoimmune diseases with an underlying inflammatory and immunologic etiology, which may be addressed by intravenous delivery of cell therapy for immunomodulation.