Generex Biotechnology Submits Pre-IND Briefing Package for Ii-Key-SARS-CoV-2 Coronavirus Prophylactic Vaccine

Strategic Insights -

Generex Biotechnology Corporation, a leading healthcare company, has submitted a pre-IND briefing package to the FDA requesting regulatory guidance on the Phase I/II clinical trial protocol and clinical development plan for its Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine. The company aims to develop a "Complete Vaccine" that generates a short-term antibody response, 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.

Key Takeaways:

  • Generex has submitted a pre-IND briefing package to the FDA for its Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine, which aims to generate a "Complete Vaccine" with long-lasting immunity against COVID-19.
  • The company has manufactured Ii-Key-SARS-CoV-2 peptides, secured blood samples from convalescent COVID-19 patients, and isolated peripheral blood monocytes cells (PBMCs) for testing.
  • The Phase I/II human clinical trial protocol is designed to determine the exact immunological responses generated by Ii-Key vaccination and measure the immune system's memory and long-term immunity.
  • Generex's CEO, Joseph Moscato, emphasized the company's commitment to safety, stating that the protocol provides for a thorough immunology analysis and immuno-oncology research.
  • The company aims to work with the FDA to define a clear path to commercialization for its Ii-Key-SARS-CoV-2 vaccine and keep investors informed as the development program progresses.

Statistics:

  • 11 weeks have passed since Generex filed its application with BARDA for the development of a COVID-19 vaccine.
  • The Ii-Key-SARS-CoV-2 peptides have been selected through computational analysis of the viral sequence.
  • The protocol provides for a total of 120 participants in the Phase I/II clinical trial.
  • 60 participants will receive the Ii-Key-SARS-CoV-2 vaccine, while 60 participants will serve as a control group.
  • The study aims to enroll participants at multiple sites across the United States.

Sources:

  • Generex Biotechnology Corporation website
  • GlobeNewswire via COMTEX press release, Jul 20, 2020
  • Marketslant via OTC Markets press release (Jan 20, 2020) - stock symbol GNBT
  • SOURCE Generex Biotechnology Corporation