IRX Therapeutics reports positive IRX-2 phase 2a head and neck squamous cell carcinoma clinical results

IRX Therapeutics presented results from a Phase 2a clinical trial of IRX-2, the company’s lead drug candidate, in head and neck squamous cell carcinoma (SCCHN) at the European Society for Medical Oncology (ESMO) Annual Congress 2017.

“The results presented today demonstrate that IRX-2, a primary cell-derived biologic, drives intratumoral immune infiltration of T cells, B cells and dendritic cells, promoting their activation. This increase in lymphocyte infiltration was associated with reductions in tumor size and an overall survival rate of 65% at 5 years in patients with head and neck squamous cell carcinoma,” said Gregory T. Wolf, M.D., Professor Emeritus, Department of Otolaryngology-Head and Neck Surgery, University of Michigan Comprehensive Cancer Center. “These data demonstrate that IRX-2 modulates the tumor microenvironment in cancer cells and may improve patient outcomes in this difficult-to-treat patient population.”

In a subset study of 7 patients, the study also demonstrated that IRX-2 upregulates immune checkpoint markers, including PDL1 and CTLA4 expression, suggesting that the effects of IRX-2 treatment may be enhanced by combination therapy with checkpoint inhibitors. The clinical trial also demonstrated that IRX-2 promotes expression of chemokine pathway genes (CCLs, CCRs, CXCLs and CXCRs), which are chemoattractants whose expression may result in increased lymphocyte infiltration.

“The data presented provides evidence that IRX-2 offers a durable improvement in head and neck cancer patient outcomes and has a unique mechanism of action that suggests restored immune function and activation in the tumor microenvironment,” said Mark Leuchtenberger, President and Chief Executive Officer of IRX Therapeutics. “Based on these encouraging results, we are currently conducting a Phase 2b multicenter, randomized trial (INSPIRE) in neoadjuvant SCCHN. We are also collaborating with investigators and companies with checkpoint inhibitors to assess IRX-2 as treatment for breast cancer (NCT02950259) and in multiple other tumor types with and without checkpoint inhibitors. We believe that IRX-2 has the potential to enhance patient outcomes across a variety of cancer indications and may also improve outcomes when used in combination with checkpoint inhibitors.”