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