IRX Therapeutics, a clinical-stage bioresearch company developing cancer immunotherapies, and ImmunID, an immune molecular diagnostics and precision medicine company, have entered into a collaboration agreement for prediction of response to the IRX-2 immunotherapy candidate using the ImmunTraCkeR assay.

Under the collaboration, ImmunID will use its flagship clinical product, ImmunTraCkeR, to assess the immune-modulatory effect of IRX-2 in patients with newly diagnosed head and neck squamous cell cancer (HNSCC) from IRX's randomized phase 2b study (IRX-2 Neoadjuvant Therapy in Head and Neck SCC to Provide Immune Response Enhancement: INSPIRE). The ImmunTraCkeR assay will be used before and after treatment with IRX-2 to understand pre-existing immunity of newly diagnosed head and neck squamous cell cancer patients; monitor T cell diversity over time in order to assess immune-modulatory effect of IRX-2; make a preliminary assessment of ImmunTraCkeR acting as a predictor of response to IRX-2.

IRX's lead product, IRX-2, is a primary cell-derived biologic with multiple active cytokine components that acts on multiple cell types of the immune system including T cells, dendritic cells and natural killer cells. Analyses of the data from the phase 2 study suggest that IRX-2 is driving changes in the blood consistent with an anticancer immune response and that IRX-2 induces increased lymphocyte infiltration into HNSCC tumors, which is correlated with improved OS. Investigators have observed clinical responses. IRX-2 is now undergoing further clinical investigation in the INSPIRE study. This randomized, phase 2b study has been designed to determine whether neoadjuvant treatment with IRX-2 in newly diagnosed HNSCC beginning before curative surgery can reduce the risk of recurrence.

ImmunID has been a pioneer in the field of immune molecular diagnostics for a decade. Its clinical product ImmunTraCkeR evaluates a patient's immune status, from a simple liquid biopsy (5ml EDTA blood), based on T lymphocyte repertoire diversity. ImmunID has developed and patented the ImmunTraCkeR diagnostic assay and is expanding its clinical utility to become the general immune companion diagnostics for immunotherapies and especially immune checkpoint agents.  

John W. Hadden II, chief executive officer of IRX Therapeutics, said, "We are pleased to be working with ImmunID. This collaboration will provide an insight into T cell diversity in patients treated with our novel immune-modulator, IRX-2, and the correlation with response to the treatment over time. We believe that ImmunID's ImmunTraCkeR assay may provide deeper insight into the clinical results we have generated to date and provide a companion diagnostic to our novel cancer treatment in the future."

Dr. Bernhard Sixt, chairman and CEO of ImmunID, added, "We are excited to collaborate with IRX Therapeutics in such an advanced development phase in immuno-oncology. ImmunTraCkeR will help to characterize the patient immune status and may help to select those highly likely to respond to IRX-2, thus widening its clinical value as a general immune companion diagnostics assay."