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Sunday, October 17, 2021

Generex Biotechnology Corporation (OTCMKTS: GNBT) Li-key Peptide; Chinese Licensing Deal

Generex Biotechnology Corporation (OTCMKTS: GNBT) is making a strong move up the charts after the Company closed a $50 million Licensing and Development Agreement with a consortium of partners in China for the Ii-Key vaccine platform technology from Generex subsidiary NuGenerex Immuno-Oncology (NGIO). Generex will receive a licensing fee of up to $50 million with $5 million paid up front for the exclusive use of the Ii-Key vaccine platform for infectious disease and cancer in China and its territories. For each product developed, Generex will receive an upfront payment, full funding for product development, regulatory approval, and commercialization in China, a $20 million success fee upon product approval, and a royalty to be determined on a case-by-case basis.

GNBT CEO Joseph Moscato stated: “This is probably the biggest deal Generex could even imagine and we are all too happy to be partners with these acclaimed institutions to help China and the world alleviate the threat of pandemic infections. Plus, we now have the ability to advance our Ii-Key cancer platform to realize the full potential of Ii-Key immunotherapies to target tumor biomarkers across oncology indications. The Ii-Key-SARS-CoV-2 vaccine is the first product under this Ii-Key platform license, and in the coming days, we will announce agreements for additional Ii-Key vaccine development projects as well as licensing deals for other products from the NuGenerex family of companies.”

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.

The Company’s subsidiary NuGenerex Immuno-Oncology, 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. 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. GNBT initially got the attention of Investors recently when it received a contract from Chinese partners to develop a COVID-19 Vaccine using li-key peptide vaccines. The Company also 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

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On November 18 GNBT announced it has closed a $50 million Licensing and Development Agreement with a consortium of partners in China for the Ii-Key vaccine platform technology from Generex subsidiary NuGenerex Immuno-Oncology (NGIO). Under the terms of the deal, Generex will receive a licensing fee of up to $50 million for the exclusive use of the Ii-Key vaccine platform for infectious disease and cancer in China and its territories. For each product developed using the Ii-Key technology under the platform license, Generex will receive an upfront payment, full funding for product development, regulatory approval, and commercialization in China, a success fee upon product approval, and a royalty to be determined on a case-by-case basis.

The agreement incorporates the first Ii-Key platform project for the development and commercialization of the Ii-Key-SARS-CoV-2 coronavirus vaccine in China, with a $5 million upfront licensing fee, 100% funding for manufacturing, development and commercial registration, a $20 million success fee for approval Ii-Key- SARS-CoV-2 vaccine in China, and royalty payments for COVID vaccine sales in China with the potential to reach several billion dollars. The Agreement incorporates provisions to advance the development of other Ii-Key vaccines for infectious diseases and cancer under separate contracts that are currently being finalized. The partnering groups have been previously announced as part of the company’s Framework Agreement. Generex is filing an 8K with the SEC, including details on the deal, as well as copies of the final agreements.

Generex CEO, Joseph Moscato said, “Our partners in China understand the science and the power of the Ii-Key technology for the regulation of the immune system to develop safe and effective vaccines for infectious disease and cancer, and with this agreement, we cement our partnership to realize the full potential of our Ii-Key vaccine technology. With this partnership, Generex is perfectly positioned in China to deploy the Ii-Key platform as the leading technology for rapid response to emerging infectious diseases. We look forward to working in mutual collaboration with our partners to advance the Ii-Key vaccine development platform. This is probably the biggest deal Generex could even imagine and we are all too happy to be partners with these acclaimed institutions to help China and the world alleviate the threat of pandemic infections. Plus, we now have the ability to advance our Ii-Key cancer platform to realize the full potential of Ii-Key immunotherapies to target tumor biomarkers across oncology indications. The Ii-Key-SARS-CoV-2 vaccine is the first product under this Ii-Key platform license, and in the coming days, we will announce agreements for additional Ii-Key vaccine development projects as well as licensing deals for other products from the NuGenerex family of companies.”

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Generex Biotechnology is making a poweful move up the charts after the Company closed a $50 million Licensing and Development Agreement with a consortium of partners in China for the Ii-Key vaccine platform technology from Generex subsidiary NuGenerex Immuno-Oncology (NGIO). Generex will receive a licensing fee of up to $50 million with $5 million paid up front for the exclusive use of the Ii-Key vaccine platform for infectious disease and cancer in China and its territories. For each product developed, Generex will receive an upfront payment, full funding for product development, regulatory approval, and commercialization in China, a $20 million success fee upon product approval, and a royalty to be determined on a case-by-case basis. 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. GNBT is an ex big board stock that we have reported on for years with a long history of huge moves skyrocketing to $1.65 in March of this year and Investors are looking for a return to previous levels. 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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