In head and neck squamous cell carcinoma, the IRX-2 biologic is injected into the area of the mastoid region and drains into the lymphatic vessels, where IRX-2 has been shown to exert immunomodulatory effects through the restoration of immune function and activation of a coordinated immune response against the tumor. IRX-2 contains numerous active cytokine components, which restore and activate multiple immune cell types, including T cells, dendritic cells, and natural killer cells, that are able to recognize and destroy tumors.
To promote uptake of endogenous tumor peptides by DCs and subsequent T-cell activation during the treatment cycle, the dose of IRX-2 is divided and injected bilaterally subcutaneously (SC) into the area of the mastoid region during neoadjuvant treatment. IRX-2 is not injected intratumorally or into the lymph node, and no ultrasound guidance is needed.
During the IRX-2 Booster Regimen, when the objective is to amplify and expand an ongoing immune response, the dose of IRX-2 is divided and injected bilaterally subcutaneously into the deltoid region.