AKS-107

AKS-107 is an engineered antigen-specific immunotherapeutic designed to prevent or delay the onset of type 1 diabetes (T1D). It is a human IgG1 Fc-fusion protein, where the Fc region is fused with human insulin A and B chains. This design allows AKS-107 to present conformational insulin epitopes that bind specifically to insulin-reactive B cell receptors but do not interact with the metabolic insulin receptor, thus avoiding hypoglycemia. The molecule also incorporates a Y16A mutation in the dominant T cell epitope of insulin B(9–23) to suppress activation of pathogenic T cells. Its mechanism involves targeted deletion of autoreactive B cells implicated in T1D pathogenesis and induction of immune tolerance. Preclinical studies have shown that AKS-107 can significantly reduce or prevent spontaneous diabetes development in non-obese diabetic (NOD) mice and transgenic mouse models, with durable effects persisting after treatment cessation. The drug has demonstrated good tolerability, lack of immunogenicity in non-human primates, and a favorable pharmacokinetic profile[1][3][5][6].