iTOL-301

**iTOL-301** is an investigational regenerative therapy developed by iTolerance, Inc., combining protein and cell-based approaches leveraging stem cell sources to enable endogenous production of proteins or hormones in vivo. It utilizes the company's iTOL-100 platform, featuring a biotechnology-derived Strepavidin-FasL fusion protein mixed with biotin-PEG microgels (SA-FasL microgel), to induce localized immune tolerance at the implantation site, thereby supporting long-term engraftment and function of allogeneic cells or organoids without requiring chronic systemic immunosuppression. Targeted at conditions with high unmet medical need, it represents an early-stage program in regenerative medicine, distinct from iTolerance's diabetes-focused iTOL-101 and iTOL-102 candidates and liver failure iTOL-201.[1][3][4][9][13]