• Female researcher examining a vile during OncoVAX cancer vaccine immunotherapy research
  • The design of OncoVAX® is based on the recognition that cancers are a heterogeneous class of diseases. One class of tumors may or may not express similar functional tumor specific antigens. Using autologous tumors, which most likely would express any and all functional tumor specific antigens, obviated other problematic approaches.
  • The tenets of Vaccinology promote the fact that effective vaccines work prophylactically (prevent disease). OncoVAX® is used to treat patients with early stage disease to prevent recurrence rather than impractically attempting to use a vaccine to cure patients with late stage diseases.
  • Before testing OncoVAX® in the clinic, the basic immunological concepts were carefully tested in a relevant guinea pig model, over a period of 10 years. Most other companies used mouse models which are less relevant from an immunological point of view.
  • OncoVAX® was tested through a series of 5 dose optimization and regimen optimization clinical trials prior to performing the successful Phase IIIa clinical study.
    • All of these trials were conducted under the direction of the same scientists establishing a continuity of concept throughout the development of OncoVAX®.
  • The manufacturing process and facility for OncoVAX® is designed to the Pharmacological and Good Manufacturing requirements of the FDA including requisite sterility, potency and Identity. The biological substance and final drug product are well characterized.
  • The OncoVAX® technology platform is well covered with patents for the concept, manufacturing process and spin-off Human Monoclonal Antibodies, which may have a major market in diagnosis, and Passive Active Specific Therapy.
  • The potent immunostimulator (adjuvant) used in the first two OncoVAX® immunizations, TICE BCG, was developed in cancer immunotherapy by the present Vaccinogen team. It is standard therapy for bladder cancer and under development in ASI for Stage II colon cancer.
  • The final translational development for OncoVAX® will be based on a Phase IIIb Protocol, which has a Special Protocol Assessment ("SPA") and a Fast Track status from the FDA.
  • The final translational development of OncoVAX® is preceded by what we believe was a highly successful Phase IIIa clinical trial which was published in several prestigious medical journals and will be accepted by the FDA as supportive clinical data.
  • OncoVAX® has published clinical data and a pharmacoeconomic analysis in relevant medical journals. The latter exceeds the expectations of medical reimbursement requirements.
  • Published research has shown that chemotherapy provides no benefit to Stage II colon cancer patients which is the cause for the FDA to declare that Stage II colon cancer is an unmet medical need.
  • Due to recently improved diagnostic procedures, the percentage of Stage II cases among all colon cancers being diagnosed is growing significantly.