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iTOL-102

Expanding iTOL-100 to Stem Cell-Derived Pancreatic Islets

iTOL-102 combines our iTOL-100 immune tolerance platform with allogeneic stem cell-derived pancreatic islets for the treatment of Type 1 Diabetes. The program is designed to pair a scalable source of insulin-producing cells with localized immune protection that supports durable, functional engraftment without lifelong systemic immunosuppression.

We are finalizing the selection of a stem cell source and preparing iTOL-102 for a planned Phase 1 investigator-initiated proof-of-concept trial.

A Scalable Source of Insulin-Producing Cells

Cadaveric pancreatic islets are limited by the availability and variability of donor tissue. Advances in stem cell technology may provide a consistent and scalable source of insulin-producing pancreatic islets.

However, stem cell-derived islets remain vulnerable to immune-mediated rejection following transplantation. iTOL-102 is designed to address this challenge by co-administering the cells with iTOL-100 at the transplant site.

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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