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iTolerance

iTolerance

Miami, United States· Est.
itolerance.com
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Private Company

Total funding raised: $15M

Overview

iTolerance is a private, preclinical-stage biotech founded in 2020 and based in Miami, Florida. The company's mission is to eliminate the need for chronic immunosuppression in regenerative medicine through its proprietary iTOL-100 immunomodulatory platform, which utilizes a synthetic FasL protein. Its lead programs, iTOL-101 and iTOL-102, aim to cure Type 1 Diabetes using allogeneic cadaveric islets and stem cell-derived islets, respectively, and have shown promising preclinical results in non-human primates. The company is also exploring other applications, including a liver program (iTOL-201) and a potential program for ovarian insufficiency (iTOL-401).

Type 1 DiabetesLiver Diseases

Technology Platform

iTOL-100: A synthetic Fas ligand (FasL) protein combined with a biotin-PEG microgel, designed for co-implantation with cells or organoids to induce localized, durable immune tolerance without systemic immunosuppression.

Funding History

1
Total raised:$15M
Seed$15M

Opportunities

The primary opportunity is to deliver a functional cure for Type 1 Diabetes, a multi-billion dollar market, by eliminating the need for lifelong immunosuppression in cell therapy.
Successfully validating the iTOL-100 platform could also position the company as a key enabler for the broader allogeneic cell therapy and organoid transplantation fields, opening numerous partnership and pipeline expansion avenues.

Risk Factors

Key risks include preclinical scientific risk in translating animal data to humans, high financing risk as a private pre-revenue company, and intense competition in the Type 1 Diabetes curative therapy space.
The long-term safety of the FasL-based platform and operational execution risks in manufacturing and clinical development are also significant.

Competitive Landscape

iTolerance competes in the Type 1 Diabetes space with companies developing encapsulated islet devices (e.g., ViaCyte, Sernova), gene-edited islets, and other immune tolerance approaches. More broadly, its platform competes with other immunosuppression-free cell therapy technologies, including hypoimmune cell edits and various encapsulation methods, being pursued by larger biotech and pharma companies.

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