Uniquely Positioned

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.
It is estimated that approximately $300 million dollars has been spent over a 30-year period getting the OncoVAX® technology platform to this final translational development stage.
The manufacturing process and facility for OncoVAX® meets 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. First, as standard therapy for Bladder Cancer and now for Active Specific Immunotherapy of colon cancer.
Vaccinogen has Exclusive rights to the TICE BCG product through a supply agreement from Organon , a division of Schering-Plough for use in autologous carcinoma tumor cell vaccines.
The final translational development for OncoVAX® is 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 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.
The cumulative experience of the present Vaccinogen technical and management team with the OncoVAX® technology platform is over 75 years.
OncoVAX® has published clinical data and a pharmacoeconomic analysis in relevant medical journals. The latter exceeds the expectations of medical reimbursement requirements.