The Challenge of Complex Biologics Development
Written by Ron Guido, VP of Regulatory Affairs, IRX Therapeutics
Published in Pharma Tech Outlook
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IRX Therapeutics is a clinical-stage company developing novel immunotherapies focused on reducing the immune suppression that is seen in the cancer tumor microenvironment, 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. Data collected to date indicates that IRX-2 acts to restore and activate a coordinated immune response against the tumor. IRX-2 is a proprietary therapeutic containing numerous active cytokine components, which restores and activates multiple immune cell types, including T cells, dendritic cells, and natural killer cells to recognize and destroy tumors. 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) (clinicaltrials.gov NCT02609386) and in preoperative early stage breast cancer (ESBC) (clinicaltrials.gov NCT02950259).