MIRAMAR, Fla., July 27, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the FDA has accepted their pre-IND briefing package for the Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine, and will provide a written response by August 24, 2020. Due to the significant number of submissions relating to COVID-19, the FDA is only providing written responses rather than conducting face-to-face or teleconferences for Pre-IND meetings.
The Ii-Key-SARS-CoV-2 is designed as a “Complete Vaccine” that has the potential to induce the T-Cell and antibody immune responses that can provide protective immunity with long-lasting immunologic memory against SARS-CoV-2 in a highly specific manner to ensure safety. With their response, the FDA will comment on the Phase I/II clinical trial plan and will provide guidance on the overall development program for the Ii-Key-SARS-CoV-2 vaccine.
Generex CEO, Joseph Moscato, said, “We are pleased that the FDA has accepted our Pre-IND package and have committed the time and resources to review our Ii-Key-SARS-CoV-2 clinical trial plan. Our “Complete Vaccine” has the potential to provide an immediate antibody response and also a long-lasting neutralizing antibody response together with a CD4+ Th1 T-cell response to ensure immune system memory and long-term immunity from COVID-19. It is important to understand that for the last two decades, we have focused on the activation of the cellular CD4+ and CD8+ immune response that is essential for generating long-term memory immunity. While other vaccines target activation of the antibody response and hope to activate a cellular response, the Ii-Key technology directly charges the CD4+ T-cell response against target epitopes, and with the addition of B-cell epitopes in our Ii-Key screening program, we are developing a vaccine that activates neutralizing antibodies while eliminating those peptides that may cause antibody dependent disease enhancement (ADE) or cytokine storm, thereby providing a complete and safe immune response against SARS-CoV-2. We look forward to hearing back from the FDA about our proposed comprehensive development plan and will work with the Agency to define a clear path to commercialization for our Ii-Key-SARS-CoV-2 vaccine. We will keep our investors informed as the program progresses.”
The Ii-Key-SARS-CoV-2 is designed as a “Complete Vaccine” that has the potential to induce the T-Cell and antibody immune responses that can provide protective immunity with long-lasting immunologic memory against SARS-CoV-2 in a highly specific manner to ensure safety. With their response, the FDA will comment on the Phase I/II clinical trial plan and will provide guidance on the overall development program for the Ii-Key-SARS-CoV-2 vaccine.
Generex CEO, Joseph Moscato, said, “We are pleased that the FDA has accepted our Pre-IND package and have committed the time and resources to review our Ii-Key-SARS-CoV-2 clinical trial plan. Our “Complete Vaccine” has the potential to provide an immediate antibody response and also a long-lasting neutralizing antibody response together with a CD4+ Th1 T-cell response to ensure immune system memory and long-term immunity from COVID-19. It is important to understand that for the last two decades, we have focused on the activation of the cellular CD4+ and CD8+ immune response that is essential for generating long-term memory immunity. While other vaccines target activation of the antibody response and hope to activate a cellular response, the Ii-Key technology directly charges the CD4+ T-cell response against target epitopes, and with the addition of B-cell epitopes in our Ii-Key screening program, we are developing a vaccine that activates neutralizing antibodies while eliminating those peptides that may cause antibody dependent disease enhancement (ADE) or cytokine storm, thereby providing a complete and safe immune response against SARS-CoV-2. We look forward to hearing back from the FDA about our proposed comprehensive development plan and will work with the Agency to define a clear path to commercialization for our Ii-Key-SARS-CoV-2 vaccine. We will keep our investors informed as the program progresses.”
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