IRX-2 is a primary, cell-derived biologic with multiple active cytokine components that act on various parts of the immune system, thus addressing the need for multiple mechanisms of action to address the multiple aspects of immunosuppression in cancer.
IRX-2 is a well-defined collection of natural cytokines produced under current good manufacturing procedure(s) conditions following stimulation of human PBMCs by PHA.1 Cytokine production induced by PHA mimics that seen after brisk stimulation of human immune cells by an immunogenic pathogen or an infection. PBMC are obtained from buffy coat preparations from FDA-licensed blood banks.1
IRX-2 contains multiple human cytokines that promote or enhance an immune response. The composition of these cytokines is reproducible and extensively monitored.1
Early immunotherapeutic approaches to cancer tended to oversimplify the immune system, often based on hope that a single target or receptor might restore cellular immune responses.
Today, we know that the immune system represents a complex interaction of cells. These include the cells that interact to create an immunization, antigen-presenting cells called DCs, and different types of T cells required for an anticancer immune response. It is now known that defects in the aforementioned cells exist in cancer and that these must be reversed in order to generate effective cellular immune responses. In addition, tumors induce immune suppression through multiple mechanisms. Thus, next-generation active immunotherapies must also effectively counteract multiple mechanisms of tumor-induced immune suppression. For these reasons, the multiple cytokines present in IRX-2 may be particularly effective in reversing the multiple immune deficits in cancer patients.
Preclinical data from animal and in vitro studies demonstrate that IRX-2 acts in multiple ways to augment the immune response.1-3