AKS-107 is designed to interrupt the process leading to insulin autoimmunity. This designer Fc-insulin fusion protein binds and causes the elimination of insulin-specific B cells while preserving the rest of the B cell repertoire. It has the potential to induce immunological tolerance and prevent presentation of antigenic insulin fragments to cytotoxic T cells.
Akston, along with an academic partner, has completed pre-clinical studies that demonstrate AKS-107’s ability to significantly reduce the incidence of Type 1 Diabetes in Non-Obese Diabetic (NOD) mice. Studies of AKS-107 have confirmed the lack of immunogenicity in non-human primates (NHP). Other studies have demonstrated deletion of insulin-specific B cells in mice and in vitro reduction in insulin-specific T cell activation.
Akston has developed a Good Manufacturing Practice (GMP) master cell bank (MCB) for producing AKS-107 with satisfactory titers and purity. Production has been completed in Akston’s manufacturing facility of AKS-107 drug substance that will be used to establish a clinical study-enabling safety profile through a GLP toxicity study in cynomolgus monkeys.
Disease and therapy
Type 1 Diabetes (T1D) is an autoimmune disease in which the body attacks and destroys its own insulin-producing β-cells, leading to a lifetime of dependence on injectable insulin therapy. T1D affects over 1.25 million people in the United States and accounts for over $20B each year in direct medical and indirect costs.
Akston’s therapeutic strategy is to intervene in at-risk, pre-diabetic patients and target the problematic cells responsible for T1D, while also creating immunological tolerance to insulin, thereby lowering the chances of patients converting to autoimmune diabetes.