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Generex Biotechnology Files Pre-IND Briefing Package with FDA for Ii-Key-SARS-CoV-2 Peptide Vaccine Against the COVID-19 Pandemic
[July 20, 2020]

Generex Biotechnology Files Pre-IND Briefing Package with FDA for Ii-Key-SARS-CoV-2 Peptide Vaccine Against the COVID-19 Pandemic


  • Submitted Pre-IND briefing package outlining proposed clinical development program for Ii-Key-SARS-CoV-2 prophylactic peptide vaccine against the coronavirus pandemic
  • Final protocol submitted with package to conduct a Phase I/II human clinical trial

MIRAMAR, Fla., July 20, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the company has submitted a pre-IND briefing package to FDA requesting regulatory guidance on the Phase I/II clinical trial protocol and clinical development plan for the Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine.

The Ii-Key-SARS-CoV-2 peptide epitopes, which contain target amino acid sequences from the virus, will be screened against blood samples collected from COVID-19 convalescent (recovered) patients to select those Ii-Key peptides that activate the immune system to fight the coronavirus infection. The blood screening program, which is scheduled to begin next week, incorporates T Cell Assays, antibody screening and isolation, virus neutralization tests (PRNT – Plaque Reduction Neutralization Test), and a novel in-vitro “cytokine storm” cellular assay. Through this proprietary method, Generex can identify the Ii-Key-SARS-CoV-2 peptides vaccines most likely to stimulate the appropriate T-Cell (CD4 and CD8) responses and modulate the correct immune system responses to minimize potential for dysregulated cytokine-related inflammation, stimulate a neutralizing antibody response, with the goal of providing a broad-spectrum coverage for the vast majority of people. This strategy leverages Ii-Key technology to develop a “Complete Vaccine” that has the potential to induce the likelihood of protective immunity with long-lasting immunologic memory against SARS-COV-2 in a highly specific manner to ensure safety.

Generex CEO, Joseph Moscato said, “Since we filed our application with BARDA for the development of a COVID-19 vaccine eleven weeks ago, we have pushed forward with our Ii-Key-SARS-CoV-2 vaccine development program, making significant strides. We have manufactured the Ii-Key-SARS-CoV-2 peptides that have been selected based on computational analysis of the viral sequence. We have secured blood samples from convalescent COVID-19 patients and isolated the peripheral blood monocytes cells (PBMCs) that will be used by our immunology laboratories for testing o the Ii-Key peptides in our COVID-19 blood screening program. Working with our integrated team of internal and external professionals, we have finalized our protocol, which is comprehensive and highly focused on the safety of human subjects who enroll in our trials. Additionally, the protocol provides for a thorough immunology analysis to determine the exact immunological responses generated by Ii-Key vaccination. With this Pre-IND submission, we have highlighted the potential for our Ii-Key-SARS-CoV-2 to provide a “Complete Vaccine” that not only provides a short-term antibody response, but also a long-lasting neutralizing antibody response and a CD4+ Th1 T-cell response to ensure immune system memory and long-term immunity from COVID-19. We look forward to working with the FDA to define a clear path to commercialization for our Ii-Key-SARS-CoV-2 vaccine and we will keep our investors informed as the development program progresses.”



Mr. Moscato Continued, “As the months and days have passed since the onslaught of this pandemic, we have learned that this novel virus is unlike anything we’ve seen before. The systemic, long-term effects of COVID-19 such as blood clotting, respiratory distress, circulatory problems, and even neurological deficits present major problems for the population in both the short and long term. There is also evidence that the antibody responses in many COVID-19 patients are short-lived, leading to the possibility that patients who have recovered from the disease might be re-infected with the SARS-CoV-2 virus a second time, which could be even more dangerous and lethal the second time around, with more serious long-term effects. Without seroconversion from the short-lived antibody response to a long-term immunity with memory, a COVID-19 patient or a vaccine recipient that doesn’t generate the cellular responses required for memory immunity may be at risk of re-infection. This highlights the major unmet need for our Ii-Key vaccine that is designed as a “Complete Vaccine”, which can generate neutralizing antibodies via the humoral immune response and can activate the CD4+ and CD8+ cellular responses with the goal of offering long-term protection from this pandemic that continues to ravage the world.”

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.


About NuGenerex Immuno-Oncology
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.

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

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