Tolerion

About Tolerion

Tolerion, Inc. was a clinical-stage biopharmaceutical company established in 2001, with headquarters in South San Francisco, California. The company focused on developing therapies for autoimmune diseases by leveraging a proprietary platform for antigen-specific immune tolerance induction. This approach aimed to rebalance the immune system in conditions where it mistakenly attacks the body's own cells. The scientific founder and Executive Chairman was Larry Steinman, a professor at Stanford University with extensive research in neuroimmunology and a history of co-founding biotech companies. John Donovan served as the President and CEO. In 2011, Tolerion acquired the assets of Bayhill Therapeutics after Bayhill's lead candidate for multiple sclerosis failed in a Phase IIb trial.

The company's primary business was the development and clinical testing of therapeutics for autoimmune disorders, with a particular focus on Type 1 Diabetes (T1D). Its business model centered on advancing its product candidates through clinical trials to eventually achieve regulatory approval and commercialization. The company's operations were financed through venture capital, having raised a total of $43 million over two funding rounds, with investors including Sands Capital Ventures and PBM Capital.

Tolerion's lead product candidate was TOL-3021, described as a "reverse vaccine" for treating T1D. Unlike traditional vaccines that stimulate the immune system, TOL-3021 was designed to selectively suppress the specific immune cells that attack insulin-producing pancreatic beta cells. The product is a DNA plasmid that expresses proinsulin, intended to teach the immune system to tolerate these cells, thereby halting the autoimmune destruction. Phase 2 clinical trials for TOL-3021 demonstrated that it was safe and showed potential in preserving pancreatic beta-cell function and reducing the activity of disease-specific T-cells in patients with T1D. The trials were designed to assess efficacy in both newly diagnosed and established T1D patients, with the ultimate goal of reducing or eliminating the need for insulin injections. Despite its efforts and clinical advancements, the company is now listed as out of business as of April 2021.