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Li-key Peptide; The Rise of Generex Biotechnology Corporation (OTCMKTS: GNBT)

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Generex Biotechnology Corporation (OTCMKTS: GNBT) is an exciting biotech trading at the bottom of its range that has a promising COVID-19 Vaccine using li-key peptide vaccines that may be getting overlooked by Investors. GNBT is an ex big board stock that we have reported on for years.

GNBT took off at the end of February after the Company reported it had received a contract from Chinese partners to develop a COVID-19 Vaccine using li-key peptide vaccines. Generex has made significant advancements since than reporting on September 18 it and Bintai Kinden Corporation of Malaysia have signed an addendum binding the terms of the previously signed Memorandum of Understanding for the development and commercialization of the Ii-Key-SARS-CoV-2 coronavirus vaccine. Bintai has agreed to pay Generex an up-front licensing fee of $2.5 million within two weeks. Bintai will pay 100% of the funding required for the commercial development of the Ii-Key-CoV-2 vaccine and upon approval, Bintai will pay Generex a $17.5 million milestone payment and Generex will earn royalties on sales of the vaccine equal to $3 per dose on government sales and $4.50 per dose in the private sector. .

Generex Biotechnology Corporation (OTCMKTS: GNBT) is a biotech based in Miramar, Florida, with offices in Dallas, Texas, Toronto, Canada and Wellesley, Massachusetts. The Company is focused on the commercialization of Oral-lyn buccal insulin spray for diabetes. Additionally, through its wholly-owned subsidiary Antigen Express, the Comapny has a deep intellectual property portfolio of immunotherapy assets relating to the “Ii-Key” technology that activates the immune response for the treatment of cancer and infectious diseases. Generex has completed a Phase IIb clinical trial of AE37 immunotherapeutic peptide vaccine with the Ii-Key technology in over 300 women with breast cancer. The Company believes its legacy diagnostics, diabetes, cancer assets and IP portfolio have significant value which is not being recognized due to missteps in the clinical development process by previous management, resulting inability to raise capital necessary to fund further development.

Generex and its subsidiaries are currently pursuing the development of a SARS-CoV-2 vaccine using the company’s patented Ii-Key peptide vaccine technology. To this end, the Company applied for funding to BARDA in the U.S., Health Canada, and the Malaysian Ministry of Health as well as with CEPI, the international public/private consortium focused on the development of vaccines for the global market. To date, Generex has identified viral epitopes through computer vaccinology algorithms, and manufactured those peptide sequences with the Ii-Key moiety for testing in immunological screening program using convalescent blood samples from patients who have recovered from COVID-19. The immunological blood screening program is scheduled to begin shortly. Manufacturing partners have been identified for clinical and commercial supply. Completion of the ii-Key-SARS-CoV-2 peptide vaccine program is dependent on obtaining funding from government and/or private sources.

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On September 18 GNBT reported it and Bintai Kinden Corporation of Malaysia have signed an addendum binding the terms of the previously signed Memorandum of Understanding for the development and commercialization of the Ii-Key-SARS-CoV-2 coronavirus vaccine. Under the terms of the Addendum, Bintai and Generex will finalize the legal and contractual documentation for the contract, partnership, and licensing & research agreement, and Bintai will pay Generex an up-front licensing fee of $2.5 million within two weeks. Additionally, Bintai will pay 100% of the funding required for the commercial development of the Ii-Key-CoV-2 vaccine including laboratory work, manufacturing, regulatory filings and the clinical development program for regulatory approval of the vaccine in Malaysia. Also, upon approval of the Ii-Key-CoV-2 vaccine in Malaysia, Bintai will pay Generex a $17.5 million milestone payment and Generex will earn royalties on sales of the vaccine equal to $3 per dose on government sales and $4.50 per dose in the private sector. Further, under this new Addendum, Bintai will have the right of first refusal for the Ii-Key-SARS-CoV-2 vaccine in Australia, New Zealand, and the global HALAL markets, particularly in Southeast Asia.

Generex CEO, Joseph Moscato said, “The Ii-Key platform has demonstrated that AE37, our Ii-Key-HER2 vaccine provides long-term immune memory with cellular responses active for three years in prostate cancer1, and statistically significant benefit in disease free survival for breast cancer patients with advanced disease and low HER2 expression2. Immunologic memory is the key to providing a real solution for COVID-19. With this licensing and research agreement being finalized, we can unlock the true potential of the Ii-Key technology to provide a safe and effective vaccine to stop the SARS-CoV-2 pandemic, and to provide the long-term immune system memory needed to protect the population. Our plan is collaborative, combining U.S. and Malaysian operations to advance our Ii-Key vaccine through the clinical and regulatory process in Malaysia to eventually transfer the manufacturing to Malaysia for local production, leveraging Bintai’s expertise in industrial engineering and construction. We have initiated the blood screening program using convalescent blood and serum for COVID-19 recovered patients to select Ii-Key-SARS-CoV-2 epitopes that will comprise the final vaccine formulation, after which we will initiate GMP manufacturing for Ii-Key-SARS-CoV-2 vaccine clinical trial supply. I would like to personally thank the Bintai organization for their belief in Generex and commitment to develop a safe, effective, and universal vaccine against SARS-CoV-2 for the benefit of Malaysia, and we look forward to accelerating our COVID-19 vaccine program together.”

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Currently trading at the bottom of its range GNBT took off at the end of February after the Company reported it had received a contract from Chinese partners to develop a COVID-19 Vaccine using li-key peptide vaccines. Generex has made significant advancements since than reporting on September 18 it and Bintai Kinden Corporation of Malaysia have signed an addendum binding the terms of the previously signed Memorandum of Understanding for the development and commercialization of the I-Key-SARS-CoV-2 coronavirus vaccine. Bintai has agreed to pay Generex an up-front licensing fee of $2.5 million within two weeks. Bintai will pay 100% of the funding required for the commercial development of the Ii-Key-CoV-2 vaccine and upon approval, Bintai will pay Generex a $17.5 million milestone payment and Generex will earn royalties on sales of the vaccine equal to $3 per dose on government sales and $4.50 per dose in the private sector. GNBT is an ex big board stock that we have reported on for years. We will be updating GNBT as events unfold so make sure you are subscribed to Microcapdaily so you know what is going on with GNBT.

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Disclosure: we hold no position in GNBT either long or short and we have not been compensated for this article.

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