Generex and NuGenerex Immuno-Oncology Provide Update on Ii-Key COVID-19 Vaccine Development Program and Files Trademark Application for The Complete Vaccine

• The trademark application can be found at USPTO.gov by searching “Complete Vaccine” in the Trademark Electronic Search System (TESS)
• Ii-Key-SARS-CoV-2 vaccine enters GMP production for clinical supply
• Ii-Key epitopes selected that elicit both CD4+ T Helper cell (Th1) and CD8+ responses that are necessary for long-term immune memory
• Ii-Key epitopes elicited no Th2 T cell responses that have been linked to antibody dependent enhancement of disease and cytokine storm
• Ii-Key epitopes have been used to purify Anti-SARS-CoV-2 antibodies from convalescent COVID-19 patient serum
• Neutralizing antibodies purified with Ii-Key epitopes have potential as a therapeutic treatment for COVID-19
• Addressing emergence of mutant coronavirus strains
• Exploring new opportunities to utilize Ii-Key-SARS-CoV-2 vaccines as a targeted universal booster designed to alleviate the immune related side effects reported with the current RNA vaccines

MIRAMAR, Fla., Dec. 31, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that its majority owned public entity, NuGenerex Immuno-Oncology, Inc. (NGIO), has filed for and expects to receive a trademark for The Complete Vaccine. A complete vaccine is designed to regulate the immune system to provide a targeted, neutralizing antibody response without generating off-target, non-neutralizing antibodies that can lead to antibody dependent enhancement of disease (ADE); further a complete vaccine should activate the appropriate T cell responses to yield long-term immune memory without activating detrimental Th2 responses that have been associated with immune-related complications of COVID-19 disease.

Generex also announced that significant progress has been made on the li-Key-SARS-CoV-2 vaccine program. The team at NGIO has completed the T Cell assays and HLA typing of blood samples from 46 convalescent COVID-19 patients and 30 healthy pre-COVID donors (from 2017 and 2018), screening the immune regulatory activity of 33 Ii-Key epitopes. The results of the T cell screen demonstrated that numerous Ii-Key epitopes activate CD4+ Th1 and CD8+ responses; none of the Ii-Key epitopes tested activated any negative Th2 responses.