Generex Biotechnology Provides Guidance on the Safety of Ii-Key Peptide Vaccines for the Development of Effective Solutions to the SARS-CoV-2 Coronavirus Pandemic

• Generex’s Ii-Key peptide vaccines for infectious disease and cancer have been studied in human clinical trials involving over 300 subjects in Phase I and Phase II clinical trials
  See publications at https://generex.com/covid-19

• A Phase I clinical trial demonstrating the safety of the Ii-Key peptide vaccine for H1N5 Avian influenza (Bird Flu) and H1N1 (swine flu) was conducted in 120 subjects
   
• Working with international government health agencies to offer Ii-Key peptide vaccines for clinical testing and approval

MIRAMAR, Fla. , March 19, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today provided guidance on their work to develop a peptide vaccine against the new coronavirus SARS-CoV-2 using the company’s proprietary and patented Ii-Key immune system activation technology. This guidance is designed to assist third party groups and government agencies in their evaluation of potential vaccines against this pandemic SARS-CoV-2 virus. 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. Generex is working with our partners at EpiVax who have identified such protein fragments or epitopes to generate Ii-Key-SARS 2 peptide vaccines in collaboration with our peptide manufacturing partners. The peptides and Ii-Key are made from naturally occurring amino acids, ensuring an excellent safety profile for Ii-Key peptide vaccines.

Generex President & CEO Joseph Moscato said, “Generex wants to let everyone know that we are ready and willing to partner on our coronavirus vaccine development program with government health agencies across the globe. Based on our discussions with numerous people throughout the U.S. government and international health agencies, it is clear that additional information is needed by the authorities about the potential to rapidly create a vaccine using our Ii-Key technology to fight the COVID-19 pandemic. Generex has long standing experience developing Ii-Key peptide vaccines for infectious diseases and cancer, so we have developed a strategy to design, screen and identify vaccine peptides to any novel pathogenic virus to initiate human clinical trials in 3 to 5 months depending on regulatory agency requirements. We have vaccinated over 300 people with Ii-Key vaccines to demonstrate their safety and their ability to activate the immune response against peptide epitopes. As a public service to expedite the review of the Ii-Key vaccine technology by interested parties, we are providing a summary of safety on our Ii-Key development program from both published peer-reviewed literature as well as from our clinical investigator brochures on our website at Generex.com.”