Response to Pre-IND Comments Pre-clinical and ex-
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Posted On: 04/12/2021 8:01:11 AM
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.
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.”
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.
About Generex Biotechnology Corp.
Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.
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.
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.”
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.
About Generex Biotechnology Corp.
Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.
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