Generex Biotechnology Corporation (OTCMKTS:GNBT) submitted a Pre-IND update to the FDA outlining its proposed Phase I/II clinical study protocol and the Ii-Key-SARS-CoV-2 prophylactic peptide vaccine clinical development plan.
Generex advancing Ii-Key-SARS-CoV-2 development program
The company will screen Ii-Key-SARS-CoV-2 peptide epitopes containing specific amino acid sequences from coronavirus. Screening will be against collected blood samples from convalescent COVID-19 subjects. The objective is to pick Ii-Key peptiede triggering immune response against COVID-19 infections.The screening program incorporates T-Cell Assays, virus neutralization tests, antibody screening, isolation, and novel in-vitro cytokine storm cellular assays.
Using this proprietary tech, Generex will identify Ii-Key-SARS-CoV-2 peptide prophylactic vaccines that stimulate the CD4 and CD8 T-cell responses and modulate immune system response to reduce the potential of dysregulated cytokine-associated inflammation. They also neutralize antibody response to offer a wide-spectrum coverage in most people. The strategy exploits the Ii-Key technology in the development of a complete vaccine. This vaccine will have potential of inducing lasting protective immunity with immunologic memory against the SARS-CoV-2 virus in a safe way.
Generex progressing well in the development of COVID-19 vaccine
11 weeks ago, the company submitted its application with BARDA for developing of COVID-19 vaccine. Joseph Moscato CEO said that they have made progress in the development of the Ii-Key program. So far, they have made significant progress in manufacturing of Ii-Key-SARS-CoV-2 peptides already selected based on analysis of their viral sequence. Also Generex has collected blood samples of convalescent patients and completed isolation of preiphral monocyte cells that will be vital in the SARS-CoV-2 blood screening program.
Generex finalized its protocol focused on the safety of the subjects to be enrolled in the study. The protocol offers a comprehensive immunologic analysis that will help in determining the ideal immunological responses created by Ii-Key vaccination. Moscato added the Pre-IND submission outlines the potential of Ii-Key-SARS-CoV-2 in delivering a “Complete Vaccine” that offers antibody response and CD4+ Th1 T Cell response. This will boost memory of the immune system against the SARS-CoV-2 virus. He also said that they look forward to getting a clear commercialization path through collaboration with the FDA for the Ii-Key-SARS-CoV-2 vaccine.