IRX-2 has been evaluated in 2 previous clinical studies:

  • Phase 1 study in 13 patients with recurrent squamous cell carcinoma of the head and neck (SCCHN)
  • Phase 2a study in 27 newly diagnosed patients with SCCHN, which was conducted at top US academic centers ( NCT00210470)



Data collected in a phase 2a trial of patients with SCCHN demonstrated that neoadjuvant IRX-2 stimulated lymphocyte infiltration (LI) into the tumors and that greater LI was associated with longer survival.1,2 The overall 5-year survival rate was 65% (17/26), and in patients with a large change in LI after treatment, there was a greater than 80% probability of survival at 5 years (LIavg [average LI] vs survival, P<0.05).1


Of the 27 patients evaluable for safety, 85% experienced at least one treatment-emergent adverse event (TEAE). The most common (>10%) study drug-related TEAEs included nausea, injection site pain, headache, and dizziness. There were no drug-related deaths reported.2,3


Active studies

IRX-2 is currently the subject of an ongoing study in preoperative early stage breast cancer (ESBC) ( NCT02950259), triple-negative breast cancer, and cervical intraepithelial neoplasia/vulvar intraepithelial neoplasia (clinical NCT03267680).

Planned studies

Additional studies are planned in the following malignancies, all In combination with a checkpoint inhibitor: advanced solid tumors, relapsed locally advanced head and neck cancer, metastatic head and neck cancer, oropharyngeal/oral cavity cancer, bladder cancer, and ovarian/endometrial cancer.


Increased lymphocyte infiltration in patients with head and neck cancer treated with the IRX-2 immunotherapy regimen. Cancer Immunol Immunother. 2012;61(6):771-782.

A phase 1 safety study of an IRX-2 regimen in patients with squamous cell carcinoma of the head and neck. Am J Clin Oncol. 2011;34(2):173-178.

A short course of neoadjuvant
IRX-2 induces changes in peripheral blood lymphocyte subsets of patients with head and neck squamous cell carcinoma. Cancer Immunol Immunother. 2012;61(6):783-788.

Novel neoadjuvant immunotherapy regimen safety and survival in head and neck squamous cell cancer. Head Neck.