Definition

An anchored drug complex-based formulation consisting of an engineered variant of the cytokine interleukin-12 (IL-12) linked to an inert scaffolding composed of aluminum hydroxide, with potential immunomodulatory and antineoplastic activities. Upon intratumoral administration of engineered IL-12 variant/aluminum hydroxide complex ANK-101, IL-12 activates the immune system by promoting the secretion of interferon-gamma (IFN-g) and activating CD8+ T cells, CD4+ T cells and natural killer cells (NKs) in the tumor microenvironment (TME). The activation and expansion of these immune cells mediate cytolytic immune responses against tumor cells, thereby killing tumor cells and inhibiting tumor cell proliferation. The linking of IL-12 to aluminum hydroxide reduces the clearance of IL-12 from the tumor, prevents systemic accumulation of IL-12 and allows local and sustained accumulation of IL-12, thereby prolonging the half-life and reducing systemic toxicities.