Generex Biotechnology Files Pre-IND Briefing Package with FDA for Ii-Key-SARS-CoV-2 Peptide Vaccine Against the COVID-19 Pandemic

• Submitted Pre-IND briefing package outlining proposed clinical development program for Ii-Key-SARS-CoV-2 prophylactic peptide vaccine against the coronavirus pandemic
  
• Final protocol submitted with package to conduct a Phase I/II human clinical trial

MIRAMAR, Fla., July 20, 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 pre-IND briefing package to FDA requesting regulatory guidance on the Phase I/II clinical trial protocol and clinical development plan for the Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine.

The 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 next week, incorporates T Cell Assays, antibody screening and isolation, virus neutralization tests (PRNT – Plaque Reduction Neutralization Test), and a novel in-vitro “cytokine storm” cellular assay. Through this proprietary method, Generex can identify the Ii-Key-SARS-CoV-2 peptides vaccines most likely to stimulate the appropriate T-Cell (CD4 and CD8) responses and modulate the correct immune system responses to minimize potential for dysregulated cytokine-related inflammation, stimulate a neutralizing antibody response, with the goal of providing 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.

Generex CEO, Joseph Moscato said, “Since we filed our application with BARDA for the development of a COVID-19 vaccine eleven weeks ago, we have pushed forward with our Ii-Key-SARS-CoV-2 vaccine development program, making significant strides. We have manufactured the Ii-Key-SARS-CoV-2 peptides that have been selected based on computational analysis of the viral sequence. We have secured blood samples from convalescent COVID-19 patients and isolated the peripheral blood monocytes cells (PBMCs) that will be used by our immunology laboratories for testing of the Ii-Key peptides in our COVID-19 blood screening program. Working with our integrated team of internal and external professionals, we have finalized our protocol, which is comprehensive and highly focused on the safety of human subjects who enroll in our trials. Additionally, the protocol provides for a thorough immunology analysis to determine the exact immunological responses generated by Ii-Key vaccination. With this Pre-IND submission, we have highlighted the potential for our Ii-Key-SARS-CoV-2 to provide a “Complete Vaccine” that not only provides a short-term antibody response, but also a long-lasting neutralizing antibody response and a CD4+ Th1 T-cell response to ensure immune system memory and long-term immunity from COVID-19. We look forward to working with the FDA to define a clear path to commercialization for our Ii-Key-SARS-CoV-2 vaccine and we will keep our investors informed as the development program progresses.”