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IRX Therapeutics Presents Positive IRX-2 Phase 2a Head and Neck Squamous Cell Carcinoma Clinical Results at the European Society for Medical Oncology Annual Congress 2017

— 65{991a4518005c0acae110dc2957c3093c53aab3e18df24b42d60853d4cdca3513} overall survival rate at 5 years —
— IRX-2 demonstrates ability to modulate tumor microenvironment —

NEW YORK – September 11, 2017 – IRX Therapeutics, Inc. (IRX) today 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{991a4518005c0acae110dc2957c3093c53aab3e18df24b42d60853d4cdca3513} 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.”

About IRX Therapeutics and IRX-2

IRX Therapeutics is a clinical-stage company developing novel immunotherapies focused on reducing the immune suppression that is seen in the cancer tumor micro-environment, restoring immune function, and activating a coordinated immune response against the tumor.

The lead candidate, IRX-2 is a proprietary therapeutic containing numerous active cytokine components, which data suggests may restore and activate multiple immune cell types, including T cells, dendritic cells, and natural killer cells, that are known to recognize and attack tumors. IRX-2 is a primary cell-derived biologic of produced by stimulation of human peripheral blood mononuclear cells (PBMCs) obtained from heathy donor whole blood. Data collected to date suggest that IRX-2 reduces the immune suppression that is often seen in the cancer tumor microenvironment. This immunomodulatory activity appears to occur through the restoration of immune function and activation of a coordinated immune response against the tumor.

Currently, IRX-2 is being studied in an ongoing Phase 2b clinical trial in patients with newly diagnosed Stage II, III, and IVA squamous cell carcinoma of the head and neck (SCCHN) (INSPIRE) ( NCT02609386) and in pre-operative early stage breast cancer (ESBC) ( NCT02950259).

For more information about the Company and its clinical programs, please visit


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