Generex Biotechnology Corporation announced that the company is working with third party groups and government agencies to reactivate the previously robust research and development to generate Ii-Key peptide vaccines against pandemic viruses. The patented NuGenerex Immuno-Oncology (Formerly Antigen Express) Ii-Key technology uses synthetic peptides that mimic essential protein regions from a virus that are chemically linked to the 4-amino acid Ii-Key to ensure robust immune system activation. In particular, the Ii-Key ensures potent activation of CD4+ T cells, which in turn facilitates antibody production to ward off infection.

This Ii-Key modification can be applied to any protein fragment of any pathogen to increase the potency of immune stimulation (up to 100-fold) while maintaining absolute specificity of response. The peptides and Ii-Key are made from naturally occurring amino acids, ensuring an excellent safety profile for Ii-Key peptide vaccines. Also, there are many companies with existing facilities that can make clinical-grade synthetic peptide vaccines in hundred-kilogram quantities, providing a scalable, economically feasible rapid-response vaccine to pandemic viruses; a kilogram of Ii-Key peptide vaccine would be enough to vaccinate roughly 1 million people.

Unfortunately, when these pandemics fade out, everyone forgets about them until the next one. When the SARS scare waned, company focused all of on resources on developing Ii-Key immunotherapeutic peptide vaccines for cancer. Generex has been on the forefront of immunotherapy using on proprietary Ii-Key peptide vaccine technology.

NGIO has extensive experience with the design of viral and cancer vaccines. company designed a series of vaccine peptides for the potentially pandemic H5N1 avian influenza virus that were tested in over 120 volunteers as part of a Phase I trial. The vaccine peptides were safe, well tolerated, and generated a specific immune response as designed. NuGenerex Diagnostics (NGDx) has developed the Express II, an innovative, patent-pending, point-of-care rapid diagnostic platform.

The proprietary Express II kit design is complex enough to detect a wide range of analytes including antigens, antibodies, or protein biomarkers that are found in infectious diseases, cancer, metabolic diseases and a host of other medical conditions. Though complex, the Express II is simple enough to be performed in the physician's office or even at home by consumers. Using the Express II platform, NGDx has developed point-of-care rapid diagnostic tests for HIV, Hepatitis B Hepatitis C, Tuberculosis, Syphilis and three Malaria-specific assays.

The syphilis assay, The Express II Syphilis Treponemal Assay, which has been approved for commercialization in Europe through the European CE Marking regulatory process, is a rapid point-of-care diagnostic assay for the detection of syphilis antibodies in primary and secondary syphilis with an accuracy equal to or better than standard laboratory assays for syphilis, with sensitivities and specificities of over 99%.