Durable and Localized Immune Tolerance for Cell and Organ Therapies
We are advancing a localized immune tolerance platform designed to enable durable engraftment of transplanted cells, tissues and organoids without the need for lifelong systemic immunosuppression. Our proprietary iTOL-100 platform uses localized Treg modulation to reduce immune attack and support long-term graft survival and function. We are initially applying the platform to Type 1 Diabetes through our lead programs, iTOL-101 and iTOL-102.
Pioneering Regenerative Medicine
Without Immunosuppression
We are a data-driven and patient-centric preclinical regenerative medicine company developing potentially first-in-class technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression. Leveraging our proprietary technology platform, we are advancing a pipeline of product candidates that have the potential to cure various diseases. These platforms include iTOL-200, iTOL-201 and iTOL-401.
iTOL-100:
Localized Immune Modulation Designed to Promote Durable Treg Responses
iTOL-100 is an off-the-shelf, Treg-modulating platform engineered to create durable, localized immune tolerance. The platform is designed to support long-term graft survival across cell, tissue, organoid and organ therapies without the need for lifelong systemic immunosuppression and anti-infective drugs. iTOL-100 has demonstrated compelling graft survival across multiple preclinical studies.
iTOL-100:
Immunomodulatory Platform
iTOL-100 is a synthetic form of the naturally occurring protein, FasL, combined with a synthetic biotin-PEG microgel (SA-FasL biotin-PEG microgel) that allows convenient and effective co-administration with implanted cells or organoids to induce durable immune tolerance without the need for life-long immunosuppression.
iTOL-101 and iTOL-102: Advancing Cell-Based Therapies for Type 1 Diabetes
Our lead program, iTOL-101, combines iTOL-100 with allogeneic cadaveric pancreatic islets. In a controlled nonhuman primate study, iTOL-101 demonstrated long-term islet graft survival, glycemic control and reduced reliance on insulin. We are now advancing the program toward a Phase 1/2a investigator-initiated trial at Shanghai Changzheng Hospital, a world-class islet and organ transplant institute.
Our iTOL-102 program combines iTOL-100 with stem cell-derived pancreatic islets, offering a potentially scalable source of insulin-producing cells. We expect iTOL-102 to follow iTOL-101 into a Phase 1 proof-of-concept trial.
Development Pipeline
Patient Journeys
Patients, caregivers and family members share their real-life experiences in living with Type 1 Diabetes.
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