iTolerance, Inc.
iTolerance is a pioneering regenerative medicine company focused on developing innovative, potentially first-in-class technologies to enable tissue, organoid, or cell therapy without the need for lifelong immunosuppression. The company aims to cure various diseases such as Type 1 Diabetes, liver failure, and support large organ transplants through its proprietary platforms like iTOL-100, iTOL-101, iTOL-102, iTOL-201, and iTOL-301, leveraging advanced biotechnology and strategic collaborations.
Industries
Nr. of Employees
small (1-50)
iTolerance, Inc.
1951 NW 7th Ave., Suite 300, Miami, FL 33136
Products
Immunomodulatory microgel platform (FasL‑functionalized)
An engineered immunomodulatory microgel platform that presents immobilized Fas ligand fusion proteins on a biotinylated PEG microgel carrier for co‑administration with cell or organoid therapies to induce localized immune tolerance.
Cadaveric pancreatic islet transplantation program with localized immunomodulation
Program combining donor pancreatic islets with an immunomodulatory microgel to restore insulin secretion and control blood glucose without chronic immunosuppression; supported by preclinical NHP validation.
Stem cell‑derived pancreatic islet program with localized immunomodulation
Program combining stem cell‑derived insulin‑producing islet cells with an immunomodulatory microgel to enable an unlimited cell source for transplantation without chronic immunosuppression.
Hepatocyte‑based ectopic liver constructs with localized immunomodulation
Programs using an optimized smaller microgel formulation to co‑administer with hepatocytes to enable ectopic liver constructs and evaluate potential treatments for liver failure without chronic immunosuppression.
Regenerative protein‑producing cell therapy program
Exploratory program combining immunoprotected, stem cell‑derived producer cells with an immunomodulatory microgel to provide in vivo production of therapeutic proteins or hormones for systemic replacement.
Nanoparticle lymph‑node targeting formulation for organ transplantation
Nanoparticle formulation engineered for peri‑organ lymph node delivery of an immunomodulatory fusion protein to induce localized tolerance for large organ transplants; in vitro assessment completed with ongoing preclinical R&D.
Immunomodulatory microgel platform (FasL‑functionalized)
An engineered immunomodulatory microgel platform that presents immobilized Fas ligand fusion proteins on a biotinylated PEG microgel carrier for co‑administration with cell or organoid therapies to induce localized immune tolerance.
Cadaveric pancreatic islet transplantation program with localized immunomodulation
Program combining donor pancreatic islets with an immunomodulatory microgel to restore insulin secretion and control blood glucose without chronic immunosuppression; supported by preclinical NHP validation.
Stem cell‑derived pancreatic islet program with localized immunomodulation
Program combining stem cell‑derived insulin‑producing islet cells with an immunomodulatory microgel to enable an unlimited cell source for transplantation without chronic immunosuppression.
Hepatocyte‑based ectopic liver constructs with localized immunomodulation
Programs using an optimized smaller microgel formulation to co‑administer with hepatocytes to enable ectopic liver constructs and evaluate potential treatments for liver failure without chronic immunosuppression.
Regenerative protein‑producing cell therapy program
Exploratory program combining immunoprotected, stem cell‑derived producer cells with an immunomodulatory microgel to provide in vivo production of therapeutic proteins or hormones for systemic replacement.
Nanoparticle lymph‑node targeting formulation for organ transplantation
Nanoparticle formulation engineered for peri‑organ lymph node delivery of an immunomodulatory fusion protein to induce localized tolerance for large organ transplants; in vitro assessment completed with ongoing preclinical R&D.
Services
Partnering with cell therapy developers, academic groups and industry to co‑develop cell therapy combinations and translate preclinical findings toward clinical studies; supports joint grant funding and milestone management.
Coordination with contract development and manufacturing organizations to develop processes, produce master cell banks, qualify analytical methods, optimize formulations and manufacture cGMP drug substance for clinical studies.
Preparation for regulatory interactions and submissions including INTERACT/pre‑IND engagement, CMC strategy development and design of nonclinical safety and proof‑of‑concept studies to support IND filings.
Partnering with cell therapy developers, academic groups and industry to co‑develop cell therapy combinations and translate preclinical findings toward clinical studies; supports joint grant funding and milestone management.
Coordination with contract development and manufacturing organizations to develop processes, produce master cell banks, qualify analytical methods, optimize formulations and manufacture cGMP drug substance for clinical studies.
Preparation for regulatory interactions and submissions including INTERACT/pre‑IND engagement, CMC strategy development and design of nonclinical safety and proof‑of‑concept studies to support IND filings.
Expertise Areas
- Immune tolerance strategies for cell and tissue transplantation
- Biomaterials for localized immunomodulation
- Cell and organoid transplantation therapies
- Preclinical translational studies including non‑human primate models
Key Technologies
- Fas ligand‑functionalized immunomodulatory biomaterials
- Biotinylated PEG microgel matrices
- Streptavidin–FasL fusion protein therapeutics
- Nanoparticle formulations for lymph‑node targeting
News & Updates
Live webcast with Dr. Anthony Japour, CEO, on October 25, 2023.
Announcement of appointment of Wayne Pines to the Board of Directors.
Companies advance collaborative development of iTOL-102 for diabetes.
The USPTO issued patent no. 11,602,547 for FasL-Engineered Biomaterials with Immunomodulatory Function.
iTolerance bolsters its IP portfolio with a European patent for its regenerative microgel platform.
Live webcast with Dr. Anthony Japour, CEO, on October 25, 2023.
Announcement of appointment of Wayne Pines to the Board of Directors.
Companies advance collaborative development of iTOL-102 for diabetes.
The USPTO issued patent no. 11,602,547 for FasL-Engineered Biomaterials with Immunomodulatory Function.
iTolerance bolsters its IP portfolio with a European patent for its regenerative microgel platform.