IRX Therapeutics (IRX) is a privately-held company dedicated to the discovery and development of proprietary therapies for the treatment of cancer and viral diseases. The Company was founded by John W. Hadden, M.D., a pioneer in the field of Immunopharmacology.
The Company’s product platform under development, which is based on Dr. Hadden’s research, seeks to restore an effective cellular immune response for the treatment of advanced cancers and viral diseases by correcting both dendritic cell and T cell defects.
The Company’s lead product candidate, IRX-2, received Fast Track designation by the Food and Drug Administration. A Phase 2 clinical trial in late-stage head and neck cancer patients has been completed. The Company is now preparing to launch a pivotal global Phase 3 clinical trial for IRX-2, named the INSPIRE trial.
The immunosuppressive nature of head and neck cancer creates a potential role for immunotherapy as a neoadjuvant (treatment prior to primary surgery) intervention in the treatment of this disease. IRX-2 is being tested as an immunotherapy treatment to both improve the quality of life for patients and also increase survival. IRX Therapeutics believes that its drugs under development, including IRX-2, could be broadly applicable to a number of cancers beyond the initial indication of head and neck cancer.
Cancer is often found in patients who have severe depression of cellular immunity. This depression of cellular immunity results from tumor-produced factors (such as IL-10 and TGF-β) and the induction of host suppressor cells (like T regulatory cells or “T regs”). This immune depression is characterized by reduced T cell number and defective function of monocytes/macrophages and antigen-producing dendritic cells.
Consequently, while tumors have antigens capable of inducing tumor rejection, the tumor is able to successfully subvert the cellular immune response. The IRX-2 treatment regimen is designed with the goal of re-establishing an effective tumor rejection process by the immune system.
Head and neck cancer is a deadly disease that often goes undiagnosed until it is at an advanced stage. There are over 500,000 new cases worldwide each year, with about 45,000 new cases in the United States. Head and neck cancer is associated with high rates of recurrence and mortality and is understood to be highly immunosuppressive. The current standard of care for newly diagnosed head and neck cancer is primarily curative surgery followed by radiation therapy or, in some cases, chemoradiation. For patients indicated for curative surgery, there is no approved neoadjuvant therapy.
The mechanism of action of IRX’s product platform is different from other approaches. Unlike other immunotherapy and monoclonal antibody approaches to fighting cancer, IRX’s approach of activating an effective immune response is not tumor or pathogen specific. IRX treatments seek to restore defective and suppressed immune systems at a cellular level. Consequently, IRX believes its more generalized approach could be complementary to other cancer treatments. Similar to the current treatment for HIV/AIDS, the Company believes that the most effective future cancer treatments will ultimately involve combinations of treatments.
The Company currently has about 30 employees in New York City providing administrative and clinical operations support and in Farmingdale (New York) where the Company’s manufacturing, research and quality assurance groups are located.
To date, IRX Therapeutics has raised over $65 million from investors.
