MIRAMAR, Fla., April 14, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the company is working with corporate collaborators, academic advisors, and contract manufacturers, with guidance from BARDA and other government agencies to develop a plan and budget for testing a synthetic peptide vaccine against the coronavirus SARS-CoV-2 using the company’s proprietary and patented Ii-Key immune system activation technology. Because Generex’ subsidiary NuGenerex Immuno-Oncology (formerly Antigen Express) has a long history of developing the Ii-Key peptide vaccine technology with the goal of rapidly responding to potential pandemic threats, we have been able to rapidly mobilize our efforts so as to be prepared to respond to the COVID-19 global pandemic. By working towards partnerships and contracts with government and private collaborators, our goal is to accelerate the discovery and development of a safe and effective vaccine to help fight COVID-19.
Collaborating with government and academia
Generex is collaborating with private collaborators and academic experts to evaluate a number of peptide vaccine candidates for future clinical use. Our research partners have identified amino acid sequences that are predicted via computational algorithms to be antigenic epitopes of the SARS-CoV-2 coronavirus, and we are linking these epitopes with Ii-Key to develop a synthetic peptide vaccine.
Generex is also in discussion with U.S. and international governments to support clinical development and manufacturing capabilities for a vaccine. The company has agreed to terms with a peptide manufacturer to produce research grade peptides that will be used to screen against blood samples from patients who have recovered from COVID-19. Generex is in discussions with major contract companies to plan for the manufacturing of GMP grade clinical peptides to support the company’s planned safety and immunogenicity clinical trial, which is projected to initiate vaccinations in mid-summer.
Due to the ongoing pandemic emergency, the company is in discussions with these commercial contract manufacturers and the U.S. government to plan for the production of large-scale commercial batches of vaccine if the clinical trials are successful to support mass vaccination under a proposed emergency use authorization (EUA), as well as Phase III efficacy protocols starting in the Fall.
Researching vaccines for COVID-19
There are currently no specific treatments nor vaccines for COVID-19. Researchers across the world, including Generex, are investigating new products for the treatment and prevention of COVID-19, including the development of numerous vaccine modalities. A vaccine is a prophylaxis, or preventative, approach against disease. Through immunization, vaccines can activate a healthy immune system to produce an immune response that may provide long-term protection against viruses and bacterial pathogens. Although neutralizing antibodies are the principal defense against viral infection, two additional cell types are essential both for a robust defense and for immunological memory against subsequent infections. Cytotoxic T cells (CD8 cells) can kill the primary infected cells, the factories for virus production and release, and helper T cells (CD4 or Th cells) enhance production of both antibodies and the cytotoxic T cells and can afford immune memory for decades.
The Ii-Key technology that Generex has developed for over 15 years with tens of millions of dollars in research and development expenditures is designed to activate both the cellular (T cell) and humoral (antibody) immune response to create a “Complete Vaccine”. Generex is in discussions to develop a proprietary, patented Ii-Key-SARS-CoV-2 vaccine against the coronavirus and plans to work with the government and commercial collaborators to evaluate if vaccination with the peptide vaccine can immunize the population and protect against COVID-19. Our new, COVID-19 specific patents are currently being filed by our partner as provisional applications, and full applications will be filed in the U.S. and internationally on a country by country basis to protect the SARS-CoV-2 peptide epitopes as well as the Ii-Key-SARS-CoV-2 vaccines as additional in silico, in vitro, and in vivo data are compiled to support current and future claims. Generex has signed a licensing agreement that includes exclusivity to utilize the patented epitope sequences for Ii-Key peptide vaccines.
Generex President & CEO Joseph Moscato said, “My team and I are in discussions with the U.S. government about funding our vaccine development program, and we are speaking with people at Health Canada this week to discuss the Canadian regulatory path for approval in Canada. Our current plan is to conduct a clinical trial of our Ii-Key multivalent peptide vaccine to evaluate safety and immunogenicity as defined by activation of the cellular and humoral response. The 3-arm study design will compare the Ii-Key-SARS-CoV-2 vaccine alone and with immune adjuvant versus adjuvant alone. In the first stage of this immunogenicity trial, 20 healthy subjects will be enrolled in each arm, and will be vaccinated at day 0, given a booster vaccination on day 21, and have blood drawn for evaluation of immune response on day 31. A data safety monitoring board will review the interim results for safety and immune response before providing a go/no go decision to complete enrollment in the extension stage of the trial, which will enroll a total of an estimated 120 subjects. If approved by the FDA, this protocol will establish the data foundation for a large scale, mass vaccination protocol under an EUA.
To meet the potential demand for hundreds of millions of vaccine doses, we are in discussions with our GMP manufacturing contractors to start production of clinical/commercial supply as soon as the DSMB review is complete and satisfactory. Last week we submitted and presented our overall plan to the U.S. Corona Watch task force, and this week we will be detailing our plan in an application to BARDA. We are working diligently to achieve success by working to secure funding of the next stages of the COVID-19 vaccine development and clinical trials with the goal of having our vaccine ready for a mass vaccination by autumn if everything goes perfectly. If the clinical trials are successful, we then plan to partner with larger companies, such as retail pharmacy chains, to work towards vaccinating a large number of American and Canadian citizens to potentially protect the population against COVID-19.”
Mr. Moscato continued, “We have recruited the best of the best for our advisory panel and have identified clinical trial partners, contract manufacturers, regulatory consultants, and leading institutions, that if funding is secured and early test results are positive, will manufacture and conduct the clinical testing of our vaccine with world class leaders in virology and vaccinology. We have compiled a multidisciplinary team to prepare the BARDA proposal in the next week to 10 days. We are in discussions to secure immediate funding to support the BARDA application process and initial vaccine development work. From our knowledge, the U.S. government has nothing like the Generex COVID 19 Complete Vaccine technology in their pandemic preparedness portfolio, and while there are no guarantees that BARDA will approve our vaccine development proposal, the Ii-Key-SARS-CoV-2 vaccine is designed to be the only vaccine that specifically activates both the cellular and humoral immune response to provide long-lasting protection from COVID-19, so we are confident in our approach and position.”
Mr. Moscato concluded, “We have spoken with health authorities and officials from several other countries to discuss our vaccine development program in order to define the regulatory path and requirements for each specific country. We recognize that it is important that each participating country establish the regulatory guidelines, manufacturing processes, and clinical systems to manage vaccination of their populations. If the clinical trials are successful we will also work with local regulators on clinical trials, manufacturing, and distribution strategy for immunizing their populations."
Collaborating with government and academia
Generex is collaborating with private collaborators and academic experts to evaluate a number of peptide vaccine candidates for future clinical use. Our research partners have identified amino acid sequences that are predicted via computational algorithms to be antigenic epitopes of the SARS-CoV-2 coronavirus, and we are linking these epitopes with Ii-Key to develop a synthetic peptide vaccine.
Generex is also in discussion with U.S. and international governments to support clinical development and manufacturing capabilities for a vaccine. The company has agreed to terms with a peptide manufacturer to produce research grade peptides that will be used to screen against blood samples from patients who have recovered from COVID-19. Generex is in discussions with major contract companies to plan for the manufacturing of GMP grade clinical peptides to support the company’s planned safety and immunogenicity clinical trial, which is projected to initiate vaccinations in mid-summer.
Due to the ongoing pandemic emergency, the company is in discussions with these commercial contract manufacturers and the U.S. government to plan for the production of large-scale commercial batches of vaccine if the clinical trials are successful to support mass vaccination under a proposed emergency use authorization (EUA), as well as Phase III efficacy protocols starting in the Fall.
Researching vaccines for COVID-19
There are currently no specific treatments nor vaccines for COVID-19. Researchers across the world, including Generex, are investigating new products for the treatment and prevention of COVID-19, including the development of numerous vaccine modalities. A vaccine is a prophylaxis, or preventative, approach against disease. Through immunization, vaccines can activate a healthy immune system to produce an immune response that may provide long-term protection against viruses and bacterial pathogens. Although neutralizing antibodies are the principal defense against viral infection, two additional cell types are essential both for a robust defense and for immunological memory against subsequent infections. Cytotoxic T cells (CD8 cells) can kill the primary infected cells, the factories for virus production and release, and helper T cells (CD4 or Th cells) enhance production of both antibodies and the cytotoxic T cells and can afford immune memory for decades.
The Ii-Key technology that Generex has developed for over 15 years with tens of millions of dollars in research and development expenditures is designed to activate both the cellular (T cell) and humoral (antibody) immune response to create a “Complete Vaccine”. Generex is in discussions to develop a proprietary, patented Ii-Key-SARS-CoV-2 vaccine against the coronavirus and plans to work with the government and commercial collaborators to evaluate if vaccination with the peptide vaccine can immunize the population and protect against COVID-19. Our new, COVID-19 specific patents are currently being filed by our partner as provisional applications, and full applications will be filed in the U.S. and internationally on a country by country basis to protect the SARS-CoV-2 peptide epitopes as well as the Ii-Key-SARS-CoV-2 vaccines as additional in silico, in vitro, and in vivo data are compiled to support current and future claims. Generex has signed a licensing agreement that includes exclusivity to utilize the patented epitope sequences for Ii-Key peptide vaccines.
Generex President & CEO Joseph Moscato said, “My team and I are in discussions with the U.S. government about funding our vaccine development program, and we are speaking with people at Health Canada this week to discuss the Canadian regulatory path for approval in Canada. Our current plan is to conduct a clinical trial of our Ii-Key multivalent peptide vaccine to evaluate safety and immunogenicity as defined by activation of the cellular and humoral response. The 3-arm study design will compare the Ii-Key-SARS-CoV-2 vaccine alone and with immune adjuvant versus adjuvant alone. In the first stage of this immunogenicity trial, 20 healthy subjects will be enrolled in each arm, and will be vaccinated at day 0, given a booster vaccination on day 21, and have blood drawn for evaluation of immune response on day 31. A data safety monitoring board will review the interim results for safety and immune response before providing a go/no go decision to complete enrollment in the extension stage of the trial, which will enroll a total of an estimated 120 subjects. If approved by the FDA, this protocol will establish the data foundation for a large scale, mass vaccination protocol under an EUA.
To meet the potential demand for hundreds of millions of vaccine doses, we are in discussions with our GMP manufacturing contractors to start production of clinical/commercial supply as soon as the DSMB review is complete and satisfactory. Last week we submitted and presented our overall plan to the U.S. Corona Watch task force, and this week we will be detailing our plan in an application to BARDA. We are working diligently to achieve success by working to secure funding of the next stages of the COVID-19 vaccine development and clinical trials with the goal of having our vaccine ready for a mass vaccination by autumn if everything goes perfectly. If the clinical trials are successful, we then plan to partner with larger companies, such as retail pharmacy chains, to work towards vaccinating a large number of American and Canadian citizens to potentially protect the population against COVID-19.”
Mr. Moscato continued, “We have recruited the best of the best for our advisory panel and have identified clinical trial partners, contract manufacturers, regulatory consultants, and leading institutions, that if funding is secured and early test results are positive, will manufacture and conduct the clinical testing of our vaccine with world class leaders in virology and vaccinology. We have compiled a multidisciplinary team to prepare the BARDA proposal in the next week to 10 days. We are in discussions to secure immediate funding to support the BARDA application process and initial vaccine development work. From our knowledge, the U.S. government has nothing like the Generex COVID 19 Complete Vaccine technology in their pandemic preparedness portfolio, and while there are no guarantees that BARDA will approve our vaccine development proposal, the Ii-Key-SARS-CoV-2 vaccine is designed to be the only vaccine that specifically activates both the cellular and humoral immune response to provide long-lasting protection from COVID-19, so we are confident in our approach and position.”
Mr. Moscato concluded, “We have spoken with health authorities and officials from several other countries to discuss our vaccine development program in order to define the regulatory path and requirements for each specific country. We recognize that it is important that each participating country establish the regulatory guidelines, manufacturing processes, and clinical systems to manage vaccination of their populations. If the clinical trials are successful we will also work with local regulators on clinical trials, manufacturing, and distribution strategy for immunizing their populations."
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