NuGenerex Immuno-Oncology Submits Protocol, Data, and Manufacturing Information to FDA in Advance of the IND Submission - Seite 3

Mr. Moscato concluded, “NGIO has worked diligently for a year to show the power of the Ii-Key vaccine technology to rapidly respond to the pandemic with a scientific approach that has enabled us to have a COVID vaccine that has been developed as a Complete Vaccine.  The global market is in desperate need for vaccines, and there is a large portion of the U.S. and European markets that have yet to be vaccinated. Problems have been reported with the currently available vaccines, both in regard to adverse reactions like blood clots and lack of efficacy for at least one major global manufacturer, so new vaccines are still in high demand. There are also questions about the duration of protection provided by vaccines and there is discussion about the need for annual booster vaccinations.”

“Our Ii-Key COVID vaccine offers an alternative to gene therapy RNA and DNA vaccines, as our vaccine is synthetically manufactured for straight-forward scale-up and is formulated as a dry powder for easy transport and storage as compared to competitive vaccines. The GMP process is completed, so we are confident in our ability to manufacture enough amino acid peptide-based Ii-Key COVID vaccine to alleviate the global SARS-CoV-2 vaccine supply problems that are caused not only by manufacturing issues, but also the difficulty in transporting the ultra-cold products. The mechanism of our Ii-Key vaccine is to generate long-term immune memory, as we have demonstrated in our breast and prostate cancer clinical trials with our other Ii-Key vaccine AE37, the Ii-Key COVID vaccine has the potential to eliminate the need for annual booster vaccinations. We are happy to provide the FDA with the revised protocol as well as the data and information they requested, and we look forward to advancing the Ii-Key-SARS-COV-2 vaccine into the clinic this summer.”

About NuGenerex Immuno-Oncology Inc.
NuGenerex Immuno-Oncology, a subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines for cancer and infectious disease based on the CD4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) has been spun out of Generex as a separate public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors for the treatment of cancer. NGIO is currently engaged in a Phase II clinical trial of its lead cancer immunotherapeutic vaccine AE37 in combination with pembrolizumab (Merck’s Keytruda) for the treatment of triple negative breast cancer. The company has also turned its Ii-Key technology on infectious disease, responding to the coronavirus pandemic with a SARS-CoV-2 vaccine development program.