Tolerion is a clinical-stage biopharmaceutical company founded upon breakthrough discoveries in immune modulation by Larry Steinman and colleagues at Stanford. We have an extensive product portfolio that stems from pursuing our core competencies in immunology and molecular biology. We use our novel antigen-specific immune tolerance induction platform to engineer product candidates that restore balance in autoimmune conditions in which self-antigens (or “autoantigens”) incite a destructive immune response. This approach has the important benefits of targeting the root of the pathogenic immune response without impairing normal, healthy immune surveillance.
Our first three named product candidates, one in late stage clinical trials, address autoimmune disorders with candidates invented using our tolerance induction platform. Our fourth program, a monoclonal antibody for treatment of ALS, inhibits a novel integrin discovered by Larry Steinman and capitalizes on his lifetime of work in integrin biology, including his role in the discovery and development of integrin inhibitor, Tysabri®.
TOL-3021, our lead product, is in late-stage clinical development with potential to be the first disease-modifying therapy for patients with type 1 diabetes (T1D). TOL-3021, has promising safety and efficacy data from a completed Phase 2a study in patients with T1D. In this study we saw apparent effect on biomarkers indicating a change in immune response specific to T1D and an apparent effect clinically on patients ability to produce their own insulin. We are currently enrolling adult patients with established T1D in an ongoing Phase 2 study and will soon initiate a pivotal study in adolescent patients with new onset T1D.