COVID-2019 infections vaccine is being developed by Generex Biotechnology for the preventive treatment of coronavirus infection (COVID-19 strain). The company will utilise li-Key peptide vaccine platform of NuGenerex Immune-Oncology (subsidiary of Generex Biotechnology). 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. Early research is underway in China and the US.
In March 2020, Generex Biotechnology entered into a licensing agreement with Beijing Zhonghua Investment Fund Management and Sinotek-Advocates International Industry Development for the development of coronavirus vaccine (COVID-19 strain), using the Ii-Key peptide vaccine platform of NuGenerex immune-Oncology (NGIO), a Generex’s majority owned subsidiary. According to the terms of the agreement Ii-Key peptides linked with nCOV-2019 coronavirus epitopes will be generated by Generex Biotechnology through NGIO and will be tested against the blood samples of the patients in China recovered from coronavirus infection by the Chinese partners. The data obtained will indicate the Ii-Key-nCOV epitopes recognised by the human immune system, that will eventually be developed as the potential coronavirus vaccine by Generex Biotechnology. The human clinical trials will be conducted in China and the USA. The Chinese partners will have exclusive rights to use and commercialise the products in China and will make payments to Generex Biotechnology that include upfront payment of USD$ 1 million, development expenses, royalty on each dose of vaccine produced and $USD 5 million as a licensing fee for the Ii-Key technology upon completion of development and testing. Generex Biotechnology will may payments to NuGenerex Immuno-Oncology after the receipt of the licensing payments, since the intellectual property resides with the later. 
In August 2019, Generex Biotechnology announced for a planned spin-out of its subsidiary NuGenerex Immuno-Oncology (formerly Antigen Express), which will include the Ii-Key technology and AE37 immunotherapeutic vaccine program. Based on this spin-out, NuGenerex Immuno-Oncology will separate and work as a public company. 
Key Development Milestones
In May 2020, Generex Biotechnology submitted a contract proposal to Biomedical Advanced Research and Development Authority (BARDA) to fund and support the development of a COVID-2019 vaccine against the SARS-CoV-2 coronavirus using the Ii-Key vaccine technology  .
In May 2020, Generex Biotechnology completed identification and selection of SARS-CoV-2 epitopes for development of vaccines. The company also commenced GLP manufacturing of synthetic Ii-Key-SARS-CoV-2 peptides for screening in ex vivo assays like cellular assays, antibody and virus neutralisation tests, and a in vitro cytokine storm cellular assay, using blood samples from COVID-2019 convalescent patients, in order to assess and select Ii-Key peptides that activate the immune system  .
Generex Biotechnology has initiated early research in coronavirus infections in China and the US  .