iTOL-102

A Potential Stem Cell-Derived Cure for Type 1 Diabetes

iTOL-102 is our follow-on, stem cell program being developed as a potential cure for Type 1 Diabetes. Using our proprietary biotechnology-derived protein microgel platform, iTOL-100, which acts to generate localized immune tolerance, insulin producing stem cell-derived pancreatic islets organoids will be implanted in the body. These organoids are potentially capable of secreting insulin in response to sugar intake, similar to how native pancreatic islet cells behave. Additionally, the use of stem cell-derived pancreatic islet organoids provide a potentially inexhaustible supply of insulin-producing cells.

In a preclinical non-human primate study of our lead program using allogenic pancreatic islet cells and iTOL-100, the implanted pancreatic islets were shown to act as native islets, secreting insulin in response to sugar intake. Additionally, study animals did not require long-term immunosuppression therapy.

Even with Insulin Treatment, There Remains a Significant Unmet Need in Type 1 Diabetes


Type 1 Diabetes is a chronic condition in which the pancreas produces little or no insulin. People with brittle diabetes frequently experience large swings in blood sugar that can quickly move from too high to too low or vice versa. Severely low blood sugar, called hypoglycemia, can cause sudden and unexpected seizures, coma, heart attacks, and even death.

26 million

patients worldwide

1.6 million

patients in the U.S.

70K – 100K

very severe uncontrolled
type 1 diabetes; “brittle”²

Poor glucose control has long term consequences¹

%

Retinopathy at 18 years
(45% are severe)

%

Neuropathy
at 18 years

%

Nephropathy
at 18 years

1: Insulin independence rate from 2007-2010 in 677 islet transplants from Schuetz C, Markmann JF. Islet cell transplant: Update on current clinical trials. Curr Transplant Rep. 2016;3(3):254-263: 2: Vanstone, M. Patient Perspectives on Quality of Life With Uncontrolled Type 1 Diabetes Mellitus: A Systematic Review and Qualitative Meta-synthesis. Ont Health Technol Assess Ser., 15(17), 1–29.