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Generex Biotechnology Provides Guidance on the Safety of Ii-Key Peptide Vaccines for the Development of Effective Solutions to the SARS-CoV-2 Coronavirus Pandemic
[March 19, 2020]

Generex Biotechnology Provides Guidance on the Safety of Ii-Key Peptide Vaccines for the Development of Effective Solutions to the SARS-CoV-2 Coronavirus Pandemic


  • Generex’s Ii-Key peptide vaccines for infectious disease and cancer have been studied in human clinical trials involving over 300 subjects in Phase I and Phase II clinical trials
    See publications at https://generex.com/covid-19
  • A Phase I clinical trial demonstrating the safety of the Ii-Key peptide vaccine for H1N5 Avian influenza (Bird Flu) and H1N1 (swine flu) was conducted in 120 subjects
     
  • Working with international government health agencies to offer Ii-Key peptide vaccines for clinical testing and approval

MIRAMAR, Fla. , March 19, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today provided guidance on their work to develop a peptide vaccine against the new coronavirus SARS-CoV-2 using the company’s proprietary and patented Ii-Key immune system activation technology. This guidance is designed to assist third party groups and government agencies in their evaluation of potential vaccines against this pandemic SARS-CoV-2 virus. The patented NuGenerex Immuno-Oncology (Formerly Antigen Express) Ii-Key technology uses synthetic peptides that mimic essential protein regions from a virus that are chemically linked to the 4-amino acid Ii-Key to ensure robust immune system activation. In particular, the Ii-Key ensures potent activation of CD4+ T cells, which in turn facilitates antibody production to ward off infection. This Ii-Key modification can be applied to any protein fragment of any pathogen to increase the potency of immune stimulation. Generex is working with our partners at EpiVax who have identified such protein fragments or epitopes to generate Ii-Key-SARS 2 peptide vaccines in collaboration with our peptide manufacturing partners. The peptides and Ii-Key are made from naturally occurring amino acids, ensuring an excellent safety profile for Ii-Key peptide vaccines.

Generex President & CEO Joseph Moscato said, “Generex wants to let everyone know that we are ready and willing to partner on our coronavirus vaccine development program with government health agencies across the globe. Based on our discussions with numerous people throughout the U.S. government and international health agencies, it is clear that additional information is needed by the authorities about the potential to rapidly create a vaccine using our Ii-Key technology to fight the COVID-19 pandemic. Generex has long standing experience developing Ii-Key peptide vaccines for infectious diseases and cancer, so we have developed a strategy to design, screen and identify vaccine peptides to any novel pathogenic virus to initiate uman clinical trials in 3 to 5 months depending on regulatory agency requirements. We have vaccinated over 300 people with Ii-Key vaccines to demonstrate their safety and their ability to activate the immune response against peptide epitopes. As a public service to expedite the review of the Ii-Key vaccine technology by interested parties, we are providing a summary of safety on our Ii-Key development program from both published peer-reviewed literature as well as from our clinical investigator brochures on our website at Generex.com.”



Mr. Moscato continued, “We ask that governments, health ministries, and large pharmaceutical companies please take note of the potential for Ii-Key peptide vaccines to slow the spread of the SARS-CoV-2 virus. We are advancing the coronavirus project with our partners in China, and we are available to partner with other countries to develop and commercialize our Ii-Key-SARS-2 vaccine. To date we have been in touch with the VA, BARDA, and HHS in the United States, and we are in communication with  the Canadian Ministry of Health, as well as with authorities in Greece, England, Saudi Arabia, Iceland, Indonesia, Philippines, Italy, and Romania for licensing our Ii-Key-SARS-2 peptide vaccines as well as new, patented immunotherapy technology that will provide those countries with co-ownership of the Intellectual Property in their territories. We have engaged Morris L. Reid of Mercury LLC (http://mercuryllc.com) to advise the company on international licensing strategy.”

“Defeating coronavirus requires a public/private partnership,” stated Mr. Reid, Partner at Mercury. “Government cannot do it alone and must collaborate with the private sector in order to bring the best innovation to the table.”


Mr. Moscato added his thoughts on peptide vaccines, stating, “We know one thing about vaccines and the immune response, and that is our immune system recognizes antigenic epitopes, which are made of amino acid peptides, and mounts a multicellular response to protect the body from invaders like viruses or cancer. Whether you use attenuated or killed viruses or recombinant proteins, peptides are and have been the primary pathway to create vaccines. Peptide vaccines, especially when linked with the Ii-Key, are proven to generate an immune response, and we have demonstrated the safety of various Ii-Key peptide vaccines in animal models and human clinical trials. Over the years, Generex has developed a proven process to generate rapid peptide vaccines using the latest computational algorithms to select the best peptides to create an immune response, and we can link these peptide epitopes to the Ii-key for a very powerful solution that is cost effective and easy to manufacture on a large scale. Every country in the world needs our Ii-key technology in their national health arsenal not only for this coronavirus, but also to respond to future SARS virus mutations and other potential pandemic viruses that have been on the rise the last 20 years.”

For further information from government or corporate inquiries please email:
covid-19@nugenerexio.com

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.

NuGenerex Immuno-Oncology (formerly Antigen Express), a subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines based on the CD-4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) is being spun out of Generex as a separate, independent public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors. 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.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.  Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:

Generex Biotechnology Corporation

Joseph Moscato

646-599-6222

Todd Falls

Tel: 1-800-391-6755 Extension 222  Email: investor@generex.com

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