iTolerance
iTolerance is a preclinical biotech developing a proprietary SA-FasL microgel platform (iTOL-100) that enables cell, tissue, and organoid therapies without lifelong immunosuppression, with a lead Type 1 Diabetes program (iTOL-102) that completed a Pre-IND FDA meeting in 2025.
- Company typePrivate
- Founded2020
- HeadquartersMiami, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What iTolerance does
iTolerance, Inc. is a preclinical-stage, privately-held biotechnology company developing a proprietary immunomodulatory platform (iTOL-100) built on a synthetic Streptavidin-FasL fusion protein displayed on a biotin-PEG microgel (SA-FasL microgel). The platform induces durable immune tolerance at the site of co-administered cell, tissue, or organoid therapy by triggering apoptosis of activated T-cells while expanding T-regulatory cells, eliminating the need for chronic immunosuppression that typically accompanies transplantation. The company was founded in 2020, is headquartered in Miami, Florida, and is incorporated in Delaware. It operates with 1–10 employees and is funded primarily through non-dilutive grants (notably a $1M BIRD Foundation grant in 2024) and early venture participation (e.g., Gaingels, 2022).
The company's pipeline is anchored by iTOL-101 and iTOL-102, both targeting Type 1 Diabetes via co-administration of pancreatic islets (allogeneic cadaveric for iTOL-101, stem cell-derived for iTOL-102) with iTOL-100. iTOL-102 — the lead program and the focus of the Kadimastem co-development partnership — completed a Pre-IND meeting with the FDA in February 2025. Adjacent programs extend the platform into hepatocyte/liver failure therapy (iTOL-200/iTOL-201) and large organ transplantation (iTOL-401, licensed from Georgia Tech Research Corporation). Scientific and regulatory credibility is anchored by Chief Scientist Dr. Camillo Ricordi (pioneer of clinical islet allotransplantation, H-index 119) and by co-inventors Drs. Esma Yolcu and Haval Shirwan, with peer-reviewed validation in Science Advances and Nature Materials.
The business model is licensing- and partnership-driven: iTolerance is pre-revenue, has no commercial product, and plans to monetize through co-development agreements and eventual licensing of approved therapies to larger pharmaceutical or biotech partners. The company has built a strategic and scientific advisory bench in 2025 that includes former FDA senior officials (Wayne Pines, Emily Shacter) and former Medtronic regulatory counsel (Sandra Cohen Kalter), as well as a financial advisor with a track record of raising over $1B in life sciences capital. Acknowledged collaborators include the Diabetes Research Institute (University of Miami), Breakthrough T1D (formerly JDRF), Georgia Tech, University of Louisville, University of Missouri, Kadimastem/NLS Pharmaceutics, and the BIRD Foundation.
iTolerance firmographics
Firmographics- Name
- iTolerance
- Legal name
- iTolerance, Inc.
- Website
- https://itolerance.com
- Company type
- Private
- Founded year
- 2020
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- iTolerance is a preclinical biotech developing a proprietary SA-FasL microgel platform (iTOL-100) that enables cell, tissue, and organoid therapies without lifelong immunosuppression, with a lead Type 1 Diabetes program (iTOL-102) that completed a Pre-IND FDA meeting in 2025.
- Ownership category
- akta.pro rank
iTolerance industry classification
Industry- Product category
- Regenerative Medicine
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)
- SIC
- Services-Misc Health & Allied Services, Nec (8090)
- akta.pro primary industry
- Regenerative Immunology & Inflammation Modulation (pro-regenerative biologics) (HLAAAGAL)
- akta.pro secondary industries
- Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL), Transplantation & Advanced Therapies Pharmaceuticals (incl. Cell & Gene Therapies) (HLAIAAAO), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB)
Keywords
Where iTolerance is headquartered
LocationHeadquarters
- HQ city
- Miami
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
iTolerance business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales
Revenue model
- Biopharmaceutical Product Development: Pre-clinical stage biotechnology company with no current revenue. Future revenue expected from licensing agreements, co-development partnerships, and eventual commercialization of therapeutic products through FDA approval pathways.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels7 records
iTolerance product offering
Product offeringCore offering
iTolerance is a preclinical regenerative medicine company developing a proprietary SA-FasL microgel platform (iTOL-100) that induces localized immune tolerance, enabling cell, tissue, and organ therapies without life-long immunosuppression. The company is advancing a pipeline of product candidates including iTOL-101 (allogeneic cadaveric islets) and iTOL-102 (stem cell-derived islets) for Type 1 Diabetes, iTOL-200/iTOL-201 for liver failure, and iTOL-401 for large organ transplantation.
Product overview
iTolerance is a preclinical regenerative medicine company developing a platform of immunomodulatory products centered on its core iTOL-100 technology, a SA-FasL microgel that enables cell, tissue, and organoid therapies without life-long immunosuppression. The company is advancing multiple pipeline programs: iTOL-101 and iTOL-102 for Type 1 Diabetes (using allogeneic cadaveric islets and stem cell-derived islets respectively), iTOL-200/iTOL-201 for liver function regeneration, and iTOL-401 for large organ transplantation. The platform's key differentiator is its ability to induce localized immune tolerance, eliminating the need for chronic immunosuppression that typically accompanies cell and organ transplants.
Differentiator
Problem solved
Functional benefit
Products and services
- iTOL-100 Immunomodulatory Platform
Quantifiable outcome
- Demonstrated long-term graft function with control of blood glucose levels and restoration of insulin secretion without chronic immune suppression in non-human primate studies
- +1 more outcomes
Companies that use iTolerance
Customer profileNamed customers1 record
Segments3 records
Ideal customer profiles2 records
iTolerance technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
iTolerance partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core and minor.
- NLS PharmaceuticscoreNLS Pharmaceutics merged with Kadimastem, with whom iTolerance has an ongoing collaboration for iTOL-102. The merged company framework continues BIRD Foundation support for the ITOL-102 diabetes program. NLS is a global development-stage biopharmaceutical company focused on CNS disorders.
- KadimastemcoreStrategic collaboration for iTOL-102 combining Kadimastem's IsletRx stem cell-derived pancreatic islets with iTolerance's iTOL-100 immunomodulator for Type 1 Diabetes treatment. Funded in part by BIRD Foundation grant. Successfully completed pre-IND meeting with FDA in February 2025. Kadimastem is a clinical-stage cell therapy company developing off-the-shelf allogeneic cell products.
- Diabetes Research Institute FoundationcoreCollaboration for Type 1 Diabetes cure-focused research. The DRI at University of Miami serves as fast-track center for testing iTOL-102 and designated the treatment as a potential breakthrough transplantation approach.
- Breakthrough T1D (formerly JDRF)minorBreakthrough T1D (formerly Juvenile Diabetes Research Foundation) invests in research to accelerate life-changing breakthroughs to cure, prevent and treat Type 1 Diabetes. Has invested more than $2.5 billion in research funding since inception.
- Georgia Institute of TechnologycoreAcademic collaborator where iTolerance technology was co-invented. Dr. Andrés García, scientific founder, is Executive Director of Parker H. Petit Institute for Bioengineering and Bioscience at Georgia Tech. iTOL-401 development is subject to license agreement with Georgia Tech Research Corporation.
- University of LouisvillecoreAcademic collaborator where Dr. Haval Shirwan serves as Chair and Curators' Distinguished Professor. Dr. Esma S. Yolcu serves as Gratis Professor. Co-inventors of the SA-FasL microgel technology.
- University of MissouricoreAcademic collaborator where Dr. Haval Shirwan serves as Curators' Distinguished Professor. Dr. Esma S. Yolcu serves as Professor. MU, Harvard and Georgia Tech collaborated on novel Type 1 Diabetes treatment development.
Scale indicators3 records
Recent moves6 records
Expansion highlights6 records
iTolerance competitors and assessment
Company assessmentDirect peers
- Vertex Pharmaceuticals: Vertex is advancing VX-880 and VX-264, stem-cell-derived islet cell therapies for Type 1 Diabetes, making it the most directly comparable competitor to iTolerance's iTOL-102 program. Following its acquisitions of ViaCyte and Semma Therapeutics, Vertex represents the leading well-capitalized incumbent in encapsulated and stem-cell T1D therapy.
- ViaCyte (acquired by Vertex): ViaCyte developed stem-cell-derived pancreatic islet therapies (VC-02, PEC-Direct) for Type 1 Diabetes and was acquired by Vertex in 2022. Its clinical-stage encapsulated islet platform is one of the closest technological analogues to iTolerance's iTOL-101/102 approach.
- Selecta Biosciences: Selecta developed immune tolerance platforms (ImmTOR) for biologics and gene therapies, directly addressing the same problem iTolerance's SA-FasL microgel targets: inducing antigen-specific immune tolerance to enable cell and gene therapies without chronic immunosuppression.
- Sigilon Therapeutics: Sigilon developed Afibromer biomaterial-encapsulated cell therapies designed to evade immune recognition without chronic immunosuppression, including programs for Type 1 Diabetes. Its encapsulated-cell approach is a direct technological competitor to iTolerance's microgel platform.
- Semma Therapeutics (acquired by Vertex): Semma developed large-scale stem-cell-derived pancreatic islet therapies for Type 1 Diabetes and was acquired by Vertex in 2019 for $950M. As the originator of the VX-880 program, it represents the most relevant prior comparable for stem-cell-derived islet economics.
Emerging players
- Anokion: Anokion is a clinical-stage immune tolerance company using engineered antigen-specific approaches to treat autoimmune disease and enable cell therapies without immunosuppression. Its focus on tolerance induction overlaps directly with iTolerance's mechanism of action.
- Kadimastem (merged into NLS Pharmaceutics): Kadimastem is iTolerance's development partner for iTOL-102, supplying IsletRx stem-cell-derived pancreatic islets. As a clinical-stage cell therapy company with an overlapping diabetes focus, it is simultaneously a partner and a thematic peer in regenerative cell therapy.
Broad incumbents
- Sana Biotechnology: Sana is a clinical-stage biotechnology company developing engineered cell therapies and in vivo delivery approaches, including hypoimmune cell modifications designed to evade immune rejection. Its hypoimmune platform concept is mechanistically adjacent to iTolerance's immune-tolerance approach.
- CRISPR Therapeutics: CRISPR Therapeutics is a leading gene-editing company with programs in regenerative medicine and a partnership with ViaCyte on stem-cell-derived islets edited for immune evasion. Its edited allogeneic cell approach represents an alternative immune-evasion strategy to iTolerance's FasL microgel.
- Evotec SE: Evotec is a global drug discovery and cell therapy contract development organization with active programs in iPSC-derived cell therapies, including partnerships for Type 1 Diabetes. Its infrastructure and cell-therapy manufacturing capabilities make it both a potential partner and an indirect peer in the regenerative cell-therapy space.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks7 records
Key highlights7 records
Customer concentration
iTolerance social profiles
Digital presenceiTolerance financial estimates
Financial estimateRevenue estimate
Valuation estimate
iTolerance leadership team
Management profileNumber of profiles
Profiles11 records
iTolerance funding detail
Funding detailFunding overview
Funding rounds2 records
Investors2 records
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iTolerance M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about iTolerance
What does iTolerance do?
iTolerance is a preclinical regenerative medicine company developing a proprietary SA-FasL microgel platform (iTOL-100) that induces localized immune tolerance, enabling cell, tissue, and organ therapies without life-long immunosuppression. The company is advancing a pipeline of product candidates including iTOL-101 (allogeneic cadaveric islets) and iTOL-102 (stem cell-derived islets) for Type 1 Diabetes, iTOL-200/iTOL-201 for liver failure, and iTOL-401 for large organ transplantation.
Is iTolerance a public or private company?
iTolerance is a private company. It is classified as unknown and is currently operating.
When was iTolerance founded?
iTolerance was founded in 2020. It employs 1 to 10 people.
Where is iTolerance based?
iTolerance is headquartered in Miami, United States, in the North America region.
How does iTolerance make money?
One revenue line is on record: biopharmaceutical Product Development.
Who are iTolerance's main competitors?
Direct peers on record are Vertex Pharmaceuticals, ViaCyte (acquired by Vertex), Selecta Biosciences, Sigilon Therapeutics and Semma Therapeutics (acquired by Vertex). Emerging players are Anokion and Kadimastem (merged into NLS Pharmaceutics). Broad incumbents are Sana Biotechnology, CRISPR Therapeutics and Evotec SE.
Does iTolerance have an API?
No public API is recorded for iTolerance.
What industry is iTolerance in?
iTolerance's product category is Regenerative Medicine. Its primary akta.pro industry code is HLAAAGAL, Regenerative Immunology & Inflammation Modulation (pro-regenerative biologics), with a secondary code of HLAAABAL, Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods). Its NAICS code is 541714 and its SIC code is 8090.