NuGenerex Immuno-Oncology Submits Protocol, Data, and Manufacturing Information to FDA in Advance of the IND Submission

• Response to Pre-IND Comments
• Pre-clinical and ex-vivo results
• GMP Manufacturing
• Adjuvant data
• Revised protocol as per FDA recommendations

MIRAMAR, Fla., April 12, 2021 (GLOBE NEWSWIRE) -- NuGenerex Immuno-Oncology (NGIO – www.nugenerexio.com), a subsidiary of Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT)  (“Generex” or the “Company”), an innovative and integrated healthcare holding company with end-to-end solutions for patient centric care including the development of its innovative “Complete Vaccine” to fight SARS-CoV-2, today announced the company has submitted a response package to the FDA’s comments in their Pre-IND Written Response. The package provides the data and information requested by FDA, including:

1) The Ii-Key epitope sequences selected based on results of the ex-vivo blood screening program
2) The results of the transgenic (humanized) mouse immunogenicity study demonstrating vaccine
     specific antibody production
3) GMP manufacturing information for the five Ii-Key-SARS-CoV-2 epitopes in the vaccine
4) A revised protocol that incorporates FDA’s comments and requests.

As previously reported, the results of the ex-vivo blood screening program enabled the selection of five Ii-Key-SARS-CoV-2 epitopes from the spike and membrane proteins based upon their T cell activation profiles and antibody binding from convalescent COVID-19 patient blood samples.

These five Ii-Key epitopes were tested in a mouse model that is engineered with a part of the human immune system. The results of the study showed that animals vaccinated with Ii-Key-SARS-COV-2 epitopes in combination with adjuvant produced vaccine-specific antibodies.

The five selected Ii-Key epitopes have been manufactured as GMP clinical-grade vaccine product with high purity and are ready to be formulated and filled for clinical trials, with the fill date scheduled in May. An exciting result from the manufacturing and formulation work is the development of a lyophilization process that produces a stable, powdered Ii-Key-SARS-CoV-2 vaccine that can potentially be shipped and stored at room temperature, providing a substantial commercial advantage.

The protocol has been revised as per FDA request; this submission is to ensure that the revised study design meets the standards of the agency for COVID-19 vaccines, and to confirm that the clinical endpoint analyses of immune system activation, including antibody and T cell responses are acceptable for regulatory approval.