Antigen Express, Inc. (www.antigenexpress.com), the wholly-owned immunotherapeutic subsidiary of Generex Biotechnology Corporation (www.generex.com, NasdaqCM:GNBT) is developing novel immunotherapeutic and prophylactic vaccines for a variety of indications.  The basis for the proprietary platform technologies being employed is the more potent and specific stimulation of CD4+ T helper cells.  In recent years, it has come to be appreciated that CD4+ T helper cells are critical in the development of an effective immune response to novel pathologic agents.  Through a precise understanding of the mechanisms for stimulation of CD4+ cells, Antigen scientists have developed means for modifying portions of virtually any novel pathologic agent to greatly increase the immunological recognition of that agent.  Because of the basic understanding and early application of this technology, Antigen Express has obtained broad and strong patent coverage for its platform technologies.

 
One can reasonably argue that the development of vaccines has been one of the greatest contributions to modern medicine.  While drug resistance is a common theme in the management of infectious diseases and cancers, a sufficiently activated immune system can provide for continual and specific protection against both these pathological processes.  Unfortunately, advances in vaccine development have been hampered by a lack of financial incentive within big pharma as well as skepticism that scientific understanding of immunology is sufficient to guide the development of more effective vaccines.  Recently, however, exciting results seen in the area of active cellular immunotherapy together with demonstrations of efficacy using adoptive immunotherapy have generated considerable enthusiasm in the academic community as well as in the biotechnology arena.  The story of active immunotherapy is developing similar to that of monoclonal antibodies, which were slow to enter the therapeutic marketplace but which now have clear and expanding utility.  

    The most advanced vaccine developed using the Antigen Express proprietary platform technologies is currently in a randomized Phase II clinical trial in patients with breast cancer.  To date, that immunotherapeutic vaccine has been shown to be safe, well-tolerated, and generates the desired immunological response in immunized patients.  In addition to safety and specificity, a major advantage of vaccines developed using the Antigen Express technologies is that they are manufactured by an entirely synthetic process.  This is in contrast to cell-based vaccines that require expensive, extensive and labor-intensive manipulations prior to use in a patient.  Furthermore, because vaccines developed with the Antigen Express technologies are synthetic, there is the potential for much greater flexibility in the design of vaccines, greater ease in scale-up of manufacturing as well as cost-effectiveness.  This is of particular benefit in meeting the threat posed by rapidly emerging viral threats as has been seen in the case of the potentially pandemic H5N1 avian influenza and H1H1 swine flu.