Generex and NuGenerex Immuno-Oncology Provide Update on Ii-Key COVID-19 Complete Vaccine™ Development Program

Rhea-AI Summary

Generex Biotechnology Corporation (OTCQB: GNBT) announced successful results from an immunogenicity study of its Ii-Key-SARS-CoV-2 vaccine in transgenic mice. The vaccine elicited strong CD4+ and CD8+ T cell responses, indicating potential for long-term immunity. The company plans to submit an IND for Phase I and II human clinical trials soon. Additionally, discussions are underway to license therapeutic antibodies from a major research institution for COVID-19 treatment, indicating a potential expansion of its therapeutic portfolio.

Positive

• Successful immunogenicity study results in transgenic mice showing strong immune response to the Ii-Key-SARS-CoV-2 vaccine.
• Plans to submit an IND for Phase I and II human clinical trials, indicating progress toward human testing.
• Potential partnership for licensing therapeutic antibodies could expand product offerings.

Negative

• None.

• Ii-Key-SARS-CoV-2 vaccine generates vaccine-specific antibodies and T cell responses in a transgenic mouse model
• The Ii-Key vaccine elicits both CD4+ T Helper cell (Th1) and CD8+ responses that are necessary for long-term immune memory
• Initiated discussions with a major research institution on licensing therapeutic antibodies against SARS-CoV-2
  

MIRAMAR, Fla., Feb. 24, 2021 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT)  (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the company has completed the mouse immunogenicity study with transgenic mice that have been genetically engineered with a gene from the human immune system called the DR4 human leukocyte antigen (HLA) allele, which is one of hundreds of alleles in the human immune system. HLAs are proteins - or markers -found on most cells in your body. Your immune system uses these markers to recognize which cells belong in your body and which do not. So, for example, HLA is used to match patients and donors for bone marrow or organ transplants. The Ii-Key is specific for human HLA, so therefore does not work in other species, making it difficult to evaluate vaccine efficacy in animal models. The DR4 transgenic mouse provides an opportunity to evaluate the ability of Ii-Key vaccines to generate immune responses in an animal model, recognizing that the DR4 allele is only one of dozens of human HLA epitopes contained in the Ii-Key-SARS-CoV-2 vaccine.

The results of the mouse immunogenicity study demonstrated that the Ii-Key vaccine in combination with the adjuvant produced antibodies that are directed against the Ii-Key-SARS-CoV-2 epitopes as measured by ELISA assay. T cells from the mice reacted strongly to stimulation by the Ii-Key vaccine in ex vivo studies of the mouse spleen cells which contain T and B cells, dendritic cells and macrophages, which have different immune functions. These results in a mouse model of the human immune system indicate the potential for Ii-Key-SARS-CoV-2 to be a Complete Vaccine™, though the true potential can only be determined in human clinical trials.

A Complete Vaccine™is designed to regulate the immune system to provide a targeted, neutralizing antibody response without generating off-target, non-neutralizing antibodies that can lead to antibody dependent enhancement of disease (ADE); further a complete vaccine should activate the appropriate T cell responses to yield long-term immune memory without activating detrimental Th2 responses that have been associated with immune-related complications of COVID-19 disease.

Joseph Moscato, President & CEO of Generex stated, “We are preparing our IND submission for Phase I and II human clinical trials to evaluate safety and immunogenicity of the Ii-Key vaccine, and plan to submit the IND to the FDA as soon as the GMP production of the Ii-Key vaccine is completed in the coming weeks. The Ii-Key vaccine is designed to be a Complete Vaccine, and we believe that our technology offers the safest and best route to ensure long-term immunity through T cell activation by the Ii-Key-SARS-CoV-2 epitopes in our vaccine formulation. Also, as there are still many questions surrounding long-term immunity after COVID, we plan to test the Ii-Key vaccine in people who have been previously infected with coronavirus to determine if vaccination with the Ii-Key vaccine can activate the T cell immune response to generate long-term immune memory.

Throughout the history of Generex’s Ii-Key vaccine development, several clinical trials have shown that Generex’s Ii-Key cancer vaccine is safe and promotes long-term immune memory. The safety of our Ii-Key vaccine platform is recognized by the FDA, as we do not require animal toxicology studies before we enter human trials with the Ii-Key COVID-19 vaccine. We have shown 3-year immune memory with our Ii-Key-HER-2 vaccine AE37 in breast and prostate cancer. Further, in preclinical studies of the Ii-Key-GP100 HIV vaccine, we showed that an Ii-Key booster can enhance the potency of a DNA vaccine through T cell activation. So, it must be noted that even if people get vaccinated with the current RNA and DNA vaccines, there are serious questions about their long-term effectiveness with manufacturers considering the need for annual booster shots. Because the Ii-Key vaccine is a targeted booster that is designed to provide long-term immunity through T cell activation, there is a major market opportunity to be a universal booster shot not only for vaccinated people, but also for COVID patients. Plus, with only 13% of the U.S. population vaccinated to date, and with the international market that is in dire need of vaccines, there is substantial unmet need in the marketplace. COVID is not going away.”

Mr. Moscato continued, “In addition to our work on the Ii-Key vaccine, we are very excited by the opportunity to license a series of therapeutic antibodies from a major research institute. We have signed confidentiality agreements and look forward to productive discussions to finalize a licensing agreement to initiate the clinical development of COVID-19 therapeutic solutions.”

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

FAQ

What are the results of the Ii-Key-SARS-CoV-2 vaccine study announced by Generex (GNBT)?

The study demonstrated that the Ii-Key-SARS-CoV-2 vaccine generated strong antibody and T cell responses in transgenic mice, suggesting its potential for long-term immunity.

When does Generex plan to start human clinical trials for the Ii-Key vaccine (GNBT)?

Generex plans to submit an IND for Phase I and II human clinical trials as soon as the GMP production of the Ii-Key vaccine is completed.

What is Generex's (GNBT) strategy regarding COVID-19 therapeutic antibodies?

Generex is in discussions with a major research institution to license a series of therapeutic antibodies against SARS-CoV-2, aiming to initiate clinical development.