NuGenerex Immuno-Oncology Submits Protocol, Data, and Manufacturing Information to FDA in Advance of the IND Submission - Seite 2

Joe Moscato, CEO of NuGenerex Immuno-Oncology (NGIO) and Generex Biotechnology (GNBT) said, “We have made significant progress in the development of the Ii-Key COVID vaccine. One year ago, we took it upon ourselves to use our Ii-Key technology to provide a safe, targeted, and specific Complete Vaccine that produces neutralizing antibodies and T cell activation for long term immune memory. Now, one year later, we are preparing to initiate clinical trials. Our pre-clinical and ex-vivo data to date are very encouraging, and the GMP manufacturing and formulation has gone spectacularly well. Having a lyophilized powder instead of a virus or vector that needs to be frozen at -80 C gives us a major commercial advantage, especially in developing countries worldwide. Plus, if we want to stop this pandemic, the whole world needs to be vaccinated. With only one third the United States and less than 10% of the global population vaccinated, there is significant market opportunity for our Ii-Key-SARS-CoV-2 vaccine to expand the limited supply of the current RNA and DNA vaccines.”

“It is important that people understand that the underlying power of Ii-Key vaccines is the mechanism of action that activates the T cell response necessary to trigger long-term immune memory.  Our technology uses targeted peptide epitopes as opposed to gene therapy vaccines that express the entire spike protein that generate immune responses that mimic SARS-CoV-2 infection. These are the immune reactions that have been shown to result in the serious complications of COVID like blood clots. Our targeted vaccine is designed to trigger a complete immune response with both T cells and neutralizing antibodies without inducing off-target antibody responses. As we all know the SARS-CoV-2 virus is not going away, and it is mutating into variant strains that are not only more infective and dangerous, but also have shown the capacity to evade the immune protection of the currently available vaccines. We have incorporated a region of the coronavirus that does not seem to mutate, as it is 100% conserved across SARS-1 and SARS-CoV-2. Also, as we continue to learn more about the variants and the long-term effects from COVID, we are finding that we may need annual booster vaccines because antibodies dissipate within 6 to 9 months, further highlighting the need for NuGenerex’ Ii-Key-SARS-CoV-2 vaccine, which can be a targeted, universal booster to potentially provide long term immune memory that does not require annual booster shots using whole spike gene therapy vaccines.”