Generex Biotechnology Initiates Peptide Manufacturing for Ii-Key- SARS-CoV-2 Peptide Vaccine Against the COVID-19 Pandemic

• Submitted proposal to BARDA for start-to-finish funding to develop an approved, commercial Ii-Key peptide vaccine against the SARS-CoV-2 coronavirus
  
• SARS-CoV-2 epitope identification and selection completed
• Initiated GLP manufacturing of synthetic Ii-Key-SARS-CoV-2 peptides for screening in “Ex-vivo” human trial in blood samples from COVID-19 convalescent (recovered) patients
• Obtained letters of support for BARDA Application from scientific partners, prestigious universities, major contract manufacturers, and a prominent CRO that will manage the international regulatory effort and the proposed end-to-end clinical program

MIRAMAR, Fla., May 04, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the company has submitted a contract proposal to BARDA to develop a vaccine against the SARS-CoV-2 coronavirus using the patented Ii-Key vaccine technology. Following the BARDA application, and in an effort to rapidly respond to this pandemic emergency, Generex has now initiated the manufacturing of synthetic peptides with Ii-Key linked to SARS-CoV-2 epitopes predicted by computational vaccinology algorithms.  These Ii-Key-SARS-CoV-2 peptide epitopes, which contain target amino acid sequences from the virus, will be screened against blood samples collected from COVID-19 convalescent (recovered) patients to select those Ii-Key peptides that activate the immune system to fight the coronavirus infection. The blood screening program, which is scheduled to begin to begin shortly, incorporates T Cell Assays, B Cell Assays, Antibody and Virus Neutralization tests, and a novel in-vitro “cytokine storm” cellular assay to identify the Ii-Key-SARS-CoV-2 peptides vaccines most likely to stimulate the T-Cell (CD4 and CD8) response, modulate appropriate immune system responses to minimize potential for dysregulated cytokine-related inflammation, stimulate a neutralizing antibody response, and provide a broad-spectrum coverage for the vast majority of people. This strategy leverages Ii-Key technology to develop a “Complete Vaccine” that has the potential to induce the likelihood of protective immunity with long-lasting immunologic memory against SARS-COV-2 in a highly specific manner to ensure safety. The most important aspect of this ex-vivo human trial approach is that we can select the right peptides for Ii-Key vaccine peptides that will limit the risk of off-target immune responses that may lead to a cytokine storm, and we find the answers very early in the development process before we vaccinate any human volunteers.