Immunomodulatory signal presentation via synthetic hydrogel material promotes generation of T regulatory cells (green) in the local graft microenvironment (CD3+ T cells in red, and nuclei staining in blue) after implantation into a clinically relevant transplant model for the treatment of type 1 diabetes. (Credit: Georgia Tech)
Immunomodulatory signal presentation via synthetic hydrogel material promotes generation of T regulatory cells (green) in the local graft microenvironment (CD3+ T cells in red, and nuclei staining in blue) after implantation into a clinically relevant transplant model for the treatment of type 1 diabetes. (Credit: Georgia Tech)

A University of Louisville-born therapy that helps people with Type 1 diabetes stay off immunosuppressants by re-educating the body鈥檚 immune system to accept transplanted insulin-producing cells now has a commercial partner.

iTolerance Inc., a San Mateo, California-based biotech company, has signed an exclusive license and intends to develop the therapy toward clinical use. The technology was co-invented at UofL and at the Georgia Institute of Technology with support from the National Institutes of Health and , which funds Type 1 diabetes (T1D) research.

鈥淥ur goal is to help people with Type 1 diabetes, so they don鈥檛 have to suffer the side effects that come with immunosuppressants,鈥 said Haval Shirwan, inventor and gratis professor in the UofL Department of Microbiology and Immunology.

In Type 1 diabetes, a condition affecting some 1.6 million Americans, the body鈥檚 immune system attacks cells in the pancreas that produce insulin, a hormone that regulates blood sugar. As a result, patients that receive pancreatic islet transplants need to be placed on immunosuppressants and cope with the possible side effects, including loss of appetite, nausea and increased risk of infection.

The technology works by training the immune system to accept insulin-producing cells through transplanted islets 鈥 cells taken from the pancreas. The islets are laced with a recombinant protein pioneered by Shirwan and Esma S. Yolcu, a gratis faculty member at UofL, known as Fas ligand (FasL), which 鈥渢eaches鈥 the immune system to see new graft as beneficial rather than a threat.

Once the immune system has been re-trained, the idea is to transplant healthy islet cells so the patient again can produce insulin on their own.

The UofL scientists teamed up with researchers at Georgia Tech to generate a to the graft site to ward off rejection. The technology has the potential to be an 鈥渙ff-the-shelf鈥 treatment, and the hydrogels which hold the islets can be prepared up to two weeks ahead of the transplant. The islets also don鈥檛 need to be modified for the individual patient.

鈥淲e look forward to leveraging the technology to locally and durably induce immune tolerance of organ transplants,鈥 said Cameron Gray, founder and chairman of iTolerance. 鈥淲e believe the technology has potentially far-ranging implications for engraftment.”

iTolerance holds an exclusive license to the technology through Georgia Tech and the聽, which works with startups and industry to commercialize university-born technologies.