iTOL-101
Advancing Durable Islet Transplantation for Type 1 Diabetes
iTOL-101, our lead program, combines iTOL-100 with allogeneic cadaveric pancreatic islets. The program is designed to restore insulin production while protecting the transplanted islets from immune-mediated rejection without the need for lifelong systemic immunosuppression.
We are advancing iTOL-101 toward a Phase 1/2a investigator-initiated trial at Shanghai Changzheng Hospital, a world-class islet and organ transplant institute.
Addressing the Limitations of Islet Transplantation
Pancreatic islet transplantation has demonstrated the ability to restore insulin production and improve glycemic control in people with Type 1 Diabetes. However, immune-mediated rejection and the need for lifelong systemic immunosuppression continue to limit its broader use.
iTOL-101 is designed to address these barriers by delivering pancreatic islets together with iTOL-100 at the transplant site. Localized Treg modulation is intended to reduce immune attack, support long-term islet survival and preserve insulin-producing function.
Compelling Nonhuman Primate Results
In a controlled nonhuman primate study, allogeneic pancreatic islets were co-implanted with iTOL-100 in diabetic animals.
- Long-term pancreatic islet graft survival
- Sustained glycemic control
- Restoration of insulin and C-peptide production
- Reduced reliance on external insulin
- Functional response to glucose at three and six months
Controlled Nonhuman Primate Study Evaluating Allogeneic Islet Graft Survival and Glucose Tolerance in 7 Diabetic NHPs
iTOL-100 combined with NHP cadaveric donor islets
Islet + SA-FasL Biotin-PEG Microgel (iTOL-100) Provides Long-Term Survival of Pancreatic Islet Cells, Control of Blood Glucose and Reduced Need for Insulin
iTOL-100 combined with NHP cadaveric donor islets
Positive Mouse Data with Over 90% Efficacy Vs. 0% in Control
iTOL-100 combined with NHP cadaveric donor islets
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.
8.75 million
patients worldwide2
100K – 135K
patients with very severe uncontrolled Type 1 Diabetes characterized as “brittle”4
1.6 million
adult patients over the age of 20 in U.S.3
$800K – $1.7M
average costs of patient treatment
for the payer5
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: Ogle, Graham D. 2022, Type 1 Diabetes Estimates in Children and Adults; 3: “Prevalence of Diagnosed Diabetes.” Centers for Disease Control and Prevention, 30 Sept. 2022, www.cdc.gov/diabetes/data/statistics-report/diagnosed-diabetes.html; 4: Shamard Charles, MD. “Symptoms of Uncontrolled Diabetes.” Verywell Health, www.verywellhealth.com/uncontrolled-diabetes-symptoms-5120437. Accessed 16 May 2023; 5: merican Diabetes Association. “New American Diabetes Association Report Finds Annual Costs of Diabetes to be $412.9 Billion.” American Diabetes Association, 1 Nov. 2023, https://diabetes.org/newsroom/press-releases/new-american-diabetes-association-report-finds-annual-costs-diabetes-be. Accessed 9 Oct. 2024
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