Generex Biotechnology are jointly developing peptide vaccines against the novel coronavirus SARS-CoV-2 (COV-2019) using the patented NuGenerex (subsidiary of Generex Biotechnology) Immuno-Oncology (NGIO - Formerly Antigen Express) Ii-Key technology. Early research is underway in China.
Generex Biotechnology will utilise li-Key peptide vaccine platform of NuGenerex Immune-Oncology. Major histocompatibility complex (MHC) class II associated invariant chain (Ii) derived Ii-Key peptide is involved in the regulation of the formation, trafficking, and antigen-presenting functions of MHC class II complexes, essential for the activation of T cells in the immune response. When the peptide is linked to an antigenic epitope, it displaces the resident antigens from the antigen binding grove on MHC Class II molecules. This renders the MHC molecules to present the Ii-Key epitope to selectively activate T-helper type 1 cells responses. These events increase the duration and intensity of the immune responses. The interaction reduces the binding affinity of the antigenic binding groove on the MHC class II molecule and any previously resident epitope is discharged.
In March 2020, Generex Biotechnology signed a contract with EpiVax to generate peptide vaccines against the nCOV-2019 corona virus using the patented NuGenerex Immuno-Oncology (NGIO - Formerly Antigen Express) Ii-Key technology. The companies will use EpiVax's computational tools to predict epitopes that can be used for the development of these vaccines. Using the epitopes predicted by EpiVax, Generex will manufacture a series of synthetic amino acid peptides that mimic the epitopes of the virus and will send them to China for testing. In collaboration with a team in China, Generex will test the reactivity of these peptides in blood samples that have been collected from patients who have recovered from COVID-19 infections. 
Key Development Milestones
In May 2020, Generex Biotechnology initiated ex vivo human immune system studies with convalescent blood samples that will provide the data to select the Ii-Key-SARS-CoV-2 peptides for a "complete vaccine" that promotes B cell production of neutralizing antibodies and activates CD4+ T-Cell responses (TH1) that promote immune memory and potential long-term protection from coronavirus infection  .
In May 2020, Generex Biotechnology announced that provisional patent applications have been filed for the Ii-Key-SARS-2 peptides, protecting intellectual property rights for the company and COVID-19 vaccine products based on the viral sequences with Ii-Key  .