Seraxis is a private biotechnology company launched in March 2013 with investment from angel investors, an investment fund and a VC firm. Incorporated in Singapore and the US, our GMP lab is located in Germantown, Maryland. Seraxis used proprietary technologies to develop: (1) a cell therapy that is more effective and safer than embryonic stem cell-derived therapies, and; (2) cell microencapsulation that enables the function of human pancreas cells in normal animals.
Insulin-dependent diabetes, both childhood and adult forms, can be controlled by the implant of insulin-producing cells. Insulin-producing cells that are derived from stem cells and packaged into an immune-protective device have cured diabetes in multiple rodent models.
Seraxis has improved upon this strategy by creating a proprietary stem cell line that generates highly pure populations of therapeutic pancreatic cells. These cells are unique because they are not embryonic stem cells and don't produce unsafe tumors like embryonic stem cells. Next, Seraxis developed microcapsules that enable delivery of a therapeutic dose of cells through a simple syringe. These capsules are unique because they protect human pancreatic cells in a normal animal, the most stringent test of immune protection.
Cells, Microcapsules and Pre-clinical studies
The proprietary Seraxis cells were created by harvesting cells from the islets of a human donor pancreas. The cells were genetically reprogrammed to a stable, stem cell state and cryo- preserved. These cells are safer than embryonic stem cells because they did not form tumors in mouse models. To create the cell therapy, the stem cells are guided back to the pancreatic state during a two-week incubation. An advantage to the Seraxis method is that it results in a highly pure population of pancreatic cells. A consistent problem faced by field is low purity of pancreatic cells. The higher the purity, the lower the anticipated dose of cells to achieve a cure. Before encapsulation, the cells are encouraged to grow as cell clusters that resemble pancreatic islets and express pancreatic genes
To avoid immune rejection by the patient, the pancreatic clusters are encapsulated within a proprietary membrane . The result is microcapsules containing human pancreatic cells that can be injected through a standard hypodermic syringe. The capsules enable human cells to live within the body of a healthy animal.
Stem cell-based therapies have successfully controlled diabetes in immune-compromised nude mice. However, these mutant mice are poor models for human diabetes. Mice don’t have the same requirement for insulin that humans do, and mouse insulin is different from human insulin. Diabetic mice don't receive daily injections of insulin. Instead, they receive insulin from a slow release pellet embedded in their bodies. This can keep them alive for a short time at a very high blood glucose level. Also, diabetes can be an autoimmune disease. Diabetes can therefore not be modeled in an animal that doesn’t have the immune cells that cause auto-immunity.
Seraxis’ strategy is to test the encapsulated cell therapy in a relevant animal model: the diabetic non-human primate. This is more challenging but yields more relevant results. To date, no other group has reported effective control by a stem cell-derived therapy in primates, or normal mice, with or without an immune protective barrier.
Seraxis intends to pursue these indications through internal research and development, through out-licensing of the Seraxis technology, or collaboration.
CEO and Founder
Will Rust, Ph.D. developed Seraxis from the ground up. He successfully created value for Seraxis shareholders by guiding the company to achieve its scientific and business development milestones. Will’s industry background includes positions as Director of Product Development at the ATCC and Section Manager at Lonza. His scientific background is in cell therapy development, iPS cell technology, and embryonic stem cells. Will’s career goal is to translate a practical cell therapy for insulin- dependent diabetes to the clinic.
Marie Csete, MD, PhD. President and Chief Scientist at Huntington Medical Research Institutes in Pasadena CA, Adjunct Professor of Anesthesiology at USC, and Visiting Associate in Medical Engineering at Caltech. Dr. Csete served as CSO early in CIRM's history, supervising development of their core programs.
Sanjeevi Carani, MD, PhD. Professor, Deptartment of Medicine at Karolinska Institute, Stockholm
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