Definition

Exosome engineered to display the human pro-inflammatory cytokine interleukin-12 (IL-12) in a fully active form on the surface via the exosome surface glycoprotein prostaglandin F2 receptor negative regulator (PTGFRN; CD315), with potential immunostimulating and antineoplastic activities. Upon intralesional administration of IL-12-expressing exosome CDK-003, IL-12 expressed by the exosome may activate the immune system in the tumor microenvironment (TME) by promoting the activation of natural killer (NK) cells, inducing secretion of interferon-gamma (IFN-g) and inducing cytotoxic T-lymphocyte (CTL) responses against tumor cells. This may result in immune-mediated tumor cell death, inhibition of tumor cell proliferation and inhibition of tumor angiogenesis. The exosome-based formulation may provide targeted anti-tumor immunity while minimizing off-target toxicity. PTGFRN, expressed on the surface of the exosome, enables the engagement of the IL-12 receptor (IL-12R) on immune effector cells such as T cells and NK cells.