DEVELOPING
A CELL THERAPY TO TREAT
INSULIN DEPENDENT DIABETES





WE ARE S E R A X I S D E V E L O P I N G   D I A B E T E S   T H E R A P Y .

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.


THERAPY

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.


S E R A X I S TECHNOLOGY .

Cells, Microcapsules and Pre-clinical studies


CELLS

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



MICROCAPSULES

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.


PRE-CLINICAL STUDIES


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.

S E R A X I S PIPELINE .


Type 1 diabetes

Type 1 diabetes (T1D) is caused by auto-immune destruction of the insulin-producing cells of the pancreas. T1D is the most common metabolic disease in children. The Seraxis cell therapy will first target T1D.

Type 2 diabetes

Type 2 diabetes can be caused by insulin resistance and inflammatory destruction of insulin-producing cells. Many of these patients are dependent upon insulin injections and could benefit from the Seraxis cell therapy.

Metabolic disease

The lack of specific liver enzymes is the cause of some acute and chronic liver diseases. These diseases could be targeted by an encapsulated cell therapy.

Hormone insufficiency

Hormone insufficiency is caused by diminished production of steroid hormones by hormone-producing cells and could also be a target of encapsulated cells therapy.

CNS disorders

Encapsulated cell therapy has recently been shown to ameliorate symptoms of Parkinson’s disease.

Seraxis intends to pursue these indications through internal research and development, through out-licensing of the Seraxis technology, or collaboration.

MANAGEMENT T E A M B I O T E C H N O L O G Y .

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




H E L L O C O N T A C T

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