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MyVax® Personalized Immunotherapy
Our lead product candidate, MyVax® Personalized Immunotherapy (previously referred to as GTOP-99), is an investigational treatment based on the unique genetic makeup of a patient's tumor and is designed to activate a patient's immune system to identify and attack cancer cells. As such, MyVax® Personalized Immunotherapy is commonly referred to as a patient-specific or personalized immunotherapy, an active idiotype immunotherapy, or a patient-specific or personalized cancer vaccine. This type of immunotherapy is intended to stimulate an active and durable immune response specifically against an individual patient's malignant cells. Each therapy is also tumor-specific, so that in theory, cells other than those of the tumor should not be affected. These are important differences compared to passive immunotherapies for non-Hodgkin's lymphoma (NHL), such as monoclonal antibodies that, while in circulation, target cell surface markers present on both malignant and non-malignant cells in every patient.
MyVax® Personalized Immunotherapy combines a protein derived from the patient's own tumor with an immunologic carrier protein and is administered with an immunologic adjuvant. The tumor-derived protein that is unique to each patient is the antibody expressed by the tumor cells. Each antibody has unique portions, collectively known as the idiotype, which can be recognized by the immune system. The antibody that is unique to a given patient's tumor is often referred to as the idiotype protein. Genitope's immunotherapy consists of the idiotype protein and a foreign carrier protein administered with an adjuvant to enhance the immune response.
Immunologic carrier proteins are themselves strong antigens and are used to increase the immunogenicity of the patient-specific idiotype. Adjuvants are molecules that attract and activate immune system cells at the site of immunization, which enhances the immune response. Currently, Genitope uses keyhole limpet hemocyanin, or (KLH), as a carrier protein for the idiotype protein and granulocyte macrophage-colony stimulating factor, or GM-CSF, as an adjuvant.
Active immunotherapies, similar to MyVax® Personalized Immunotherapy, for the treatment of NHL have been studied in clinical trials since the late 1980's. Results from these trials suggest that active immunotherapy may induce long-term remission and may improve survival of NHL patients. Despite these results, further development of this immunotherapeutic approach has been limited by manufacturing difficulties. We have developed a proprietary manufacturing process that overcomes many of these historical manufacturing limitations. MyVax® Personalized Immunotherapy is currently in a pivotal Phase 3 trial and additional Phase 2 trials for the treatment of B-cell non-Hodgkin's lymphoma and B-cell chronic lymphocytic leukemia.
For more information on personalized immunotherapy and our product, please see the Frequently Asked Questions in the Patient Resources section of our website.