Tolerion announced results from a Phase 2 trial demonstrating that TOL-3021 may have the potential to alleviate or shut down the destructive disease process in type 1 diabetes. Unlike conventional vaccines, which act to stimulate the immune system, the reverse vaccine TOL-3021 is designed to selectively suppress specific elements of the immune system that are inappropriately activated in type 1 diabetes. TOL-3021 contains an engineered DNA plasmid that expresses proinsulin, which is associated with the autoimmune-caused destruction characterizing type 1 diabetes.

The Phase 2 trial was a randomized, blinded, placebo-controlled, dose escalation trial in 80 adult patients with type 1 diabetes. Patients received one of four doses of TOL-3021 as an injection once a week for 12 weeks. The trial was designed to assess whether TOL-3021 could decrease autoimmune attacks on pancreatic beta cells and improve their functioning.

The results demonstrated that TOL-3021 preserved pancreatic beta-cell function while reducing destructive disease-specific T-cell activity in patients with type 1 diabetes. C-peptide, a marker of pancreatic beta cell function, improved after administration of all doses of TOL-3021 compared to placebo. For example, at week 15, C-peptide increased by 19.5% from baseline with the 1mg dose of TOL-3021, compared to a decrease of 8.8% in patients on placebo (P <0.026).  Furthermore, an indicator of underlying disease activity, the number of CD8 T-cells reactive to proinsulin, declined with TOL-3021 treatment, while T-cells against other antigens, such as infectious pathogens, were unaffected (P<0.006). 

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