IRX-2 is a late-stage development compound that has the potential to be a very important and useful weapon in the fight against cancer and other diseases. The Company is currently planning to launch a pivotal study for IRX-2, the INSPIRE trial, and has secured Fast Track designation in Head and Neck cancer.
IRX-2 is the Company's lead cancer therapy, currently in development in a neo-adjuvant regimen for the treatment of head and neck squamous cell carcinoma (“H&NSCC”). This primary oncology indication is characterized by a significant unmet medical need in this large patient population (over 500,000 incidents per year worldwide) and therefore provides a direct pathway to regulatory approval.
Immune suppression is a common element of many illnesses including cancer, infectious diseases, and allergies. IRX-2 is a unique therapy that targets multiple components of the immune system. The goal is to overcome the patient's immune suppression.
IRX-2 is a primary cell-derived biologic with multiple active components. In order to overcome the severe immune suppression associated with diseases including cancer, multiple active components are needed to restore cellular function and activate the immune system at key steps in the cellular immune pathways. The active components in IRX-2 are well known activators of T cells and DCs. The coordinated function of these cells is critical to the initiation of a functional cellular (Th1) immune response. The ability of IRX-2 to induce T cell activation and proliferation as well as DC activation and maturation may be physiologically relevant. The combination of these functions may result in significant clinical immunotherapeutic action against a variety of cancers and other diseases that may also prevent or delay recurrence of disease.
The novel mechanism of action of IRX-2 means it can be used as a platform-based therapy in many disease settings. The IRX-2 regimen not only seeks to activate the immune response but also seeks to address the damaging micro-environment created by tumor-induced mechanisms of immune suppression. IRX-2 could be applied to other cancers, such as lung cancer, breast cancer and melanoma, where severe immune suppression often limits the efficacy of current therapies, and where regional lymph nodes can be accessed. As such, the Company intends to consider developing IRX-2 for such other cancer indications once the H&NSCC program is well established.
Phase 1 and Phase 2 studies of IRX-2 therapy in H&NSCC have been completed. The survival data in the small (n=27) unrandomized Phase 2 study shows that median survival has not been reached after all patients have been followed for at least two years. As a small unrandomized trial, efficacy conclusions cannot be drawn from this study. A large randomized trial is needed to determine whether or not the IRX-2 regimen prolongs survival.
