FAQs

Q. IS IT NECESSARY TO INJECT IRX-2 INTRATUMORALLY OR DIRECTLY INTO THE LYMPH NODE USING ULTRASOUND GUIDANCE?

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.

Q. WHY IS THE IRX-2 NEOADJUVANT REGIMEN ADMINISTERED LOCALLY?

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.

Q. WHY IS THE IRX-2 NEOADJUVANT REGIMEN INITIATED PRIOR TO CURATIVE SURGERY?

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.

Q. THIS IS AN IMMUNOTHERAPEUTIC REGIMEN BUT IT STARTS WITH CYCLOPHOSPHAMIDE. WON’T THAT INHIBIT THE IMMUNE RESPONSE?

A. One mechanism to reversing nonresponse and suppression of immune responses in subjects with malignancy is to inhibit suppressor T-cell function.1,2 Evidence indicates that cyclophosphamide inhibits suppressor or T regulatory cell (Treg) number and/or function.3 Thus, a number of clinical trials that involve immunotherapy or attempt to stimulate immune response to tumor antigens have employed a relatively low dose of cyclophosphamide (300 mg/m2) as a component of the treatment regimen.

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

© 2017 IRX Therapeutics