iTOL-100

Immunomodulatory Platform Enabling the Promise of Cell Therapies

Cell Therapies have the Potential to Cure Various Diseases

• Ability to repair or replace damaged tissues and organs

• Wide range of applications:

• Regenerative Medicine

• Type 1 Diabetes

• Cancers

• Genetic Disorders

• Autoimmune Diseases

• Sources include healthy donor, cadaveric and induced pluripotent stem cells (iPSC)

Unfortunately, There Are Significant Challenges

Immune Rejection is a Significant Challenge to Efficacy of Islet Transplantation and Current Approaches Can Be Harmful to the Patient, Inhibiting Market Adoption

Cell therapy and transplantation continue to be a growing market response to various disease types. Adoption of these market solutions is hampered by either rejection by the patient’s immune system or relegating the patient to a life of immune suppression drugs that are expensive and makes the patient vulnerable to numerous co-morbidities including infections and cancer.

iTOL-100 May Be Able to Unlock the Market Potential of Cell Therapies

Immune Tolerizing Agent Platform Technology

We are developing a first-in-class therapeutic co-administered with cell therapies that potentially eliminates the need for life-long immune suppression, which would save payers millions of dollars in patient lifetime treatment costs, and improve the quality of life of patients. By leveraging our proprietary platform technology, iTOL-100, we are advancing a pipeline of programs that have the potential to cure various diseases.

How iTOL-100 is Designed to Work

iTOL-100: Our SA-FasL Microgel Immune Tolerance Platform

Through a data-driven approach, we are working to enable regenerative medicine without the need for life-long immunosuppression. Our immunomodulatory technology, iTOL-100, is a synthetic form of the naturally occurring protein, FasL, combined with a synthetic biotin polyethylene glycol, or PEG, microgel (SA-FasL microgel) which induces durable immune tolerance.  Ordinarily, activated T-cells will reject foreign tissue.  Current implantation of cells or organs requires life-long immunosuppression to prevent organ rejection.  However, when we combine iTOL-100 with the target cell therapy and implant it into the body, the FasL binds to the Fas receptor (FasR) on activated T-cells, preventing rejection through a process called apoptosis (or programmed cell death). In parallel, T-regulatory cells are expanded, creating long-term localized immune privilege and protecting the implanted cell therapy.

Potential Key Technology Benefits 

Creates durable and localized immune tolerance to enable tissues, organoid and organ implantation

Eliminates the need for chronic use of life-long immunosuppression and anti-infective drugs reducing overall treatment cost for the payer

Off-the-shelf-solution with broad utility across disease states

In preclinical studies, our iTOL-100 platform has been shown to establish durable, localized immune tolerance, allowing the implanted tissue, organoid or cell therapy to function as a replacement for damaged native cells.

Straightforward Procedure

Our proprietary technology has broad applicability and can be applied to both allogeneic and stem cell-derived organoids across a number of diseases.