A. No, IRX-2 is not injected intratumorally or directly into the lymph node. It is injected into the area of the mastoid region, and no ultrasound guidance is needed.
A. The IRX-2 Neoadjuvant Regimen is administered locally to promote uptake of endogenous tumor peptides by dendritic cells (DCs) and subsequent T-cell activation during the first treatment cycle.
A. IRX-2 is given before surgery in order to begin activating the immune system. IRX-2 is a proprietary therapeutic containing 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. IRX-2 leads to an increase in tumor activation markers, including PD-L1, suggesting a complementary role with checkpoint inhibitors.
The single immunomodulatory dose is one-fourth of a typical anticancer dose and has minimal toxicity. It is not likely to have substantial myelosuppressive or direct antitumor effects, but rather is intended to enhance the development of cell-mediated immunity by providing contrasuppression of tumor-associated immune suppression (to reduce the number and function of suppressor T cells).4-7