Generex Signs Binding Licensing & Research Agreement with Bintai Kinden to Advance the Clinical Development & Commercialization of Ii-Key-SARS-CoV-2 Coronavirus Vaccine for Malaysia
[GlobeNewswire]
Generex Biotechnology Corporation
,GlobeNewswire•September 18, 2020
Bintai Kinden Corporation Berhad (www.bintai.com.my) is an investment holding company headquartered in Malaysia with operations throughout South-East Asia, China, and the Arabian Gulf Region
Upfront licensing fee of $2.5 million
100% funding for development, manufacturing and commercial registration of Ii-Key- SARS-CoV-2 prophylactic vaccine against COVID-19 in Malaysia
Milestone payments totaling $17.5 million upon approval by Malaysian Ministry of Health
Contracted royalty of $3 - $4.50 per dose of vaccine
Potential $150 million in GNBT revenues for vaccine sales in Malaysia
Potential to expand the partnership and development agreement in Australia, New Zealand, and the global HALAL markets
MIRAMAR, Fla., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) is pleased to announce that the company 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.
Under terms of the deal, Generex and Bintai have agreed to collaborate and have developed a strategy towards the rapid development of the Ii-Key-CoV-2 vaccine for Malaysia. As part of that strategy, Generex has identified a local CRO, Jigsaw Clinical Research Solutions (https://www.jigsawclinical.com/), managed by U.S. industry veteran, Jeffrey Yablon who has decades of experience in clinical development and regulatory affairs, and has established Jigsaw as the premier Malaysian CRO.
Generex CEO, Joseph Moscato said, “We want to thank our partners at Bintai for their commitment to develop our Ii-Key-SARS-CoV-2 “Complete Vaccine” against COVID-19. Our Ii-Key vaccine platform has always been about activation of the cellular immune system pathway via Ii-Key, which imparts long term memory through T-Helper cells. Our Ii-Key-SARS-CoV-2 vaccine strategy combines the Ii-Key T-Cell response with B-Cell epitopes that activate the humoral (antibody) response to deliver a Complete Vaccine for short and long-term protection from COVID-19. 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.”
Mr. Moscato continued, “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.”
[GlobeNewswire]
Generex Biotechnology Corporation
,GlobeNewswire•September 18, 2020
Bintai Kinden Corporation Berhad (www.bintai.com.my) is an investment holding company headquartered in Malaysia with operations throughout South-East Asia, China, and the Arabian Gulf Region
Upfront licensing fee of $2.5 million
100% funding for development, manufacturing and commercial registration of Ii-Key- SARS-CoV-2 prophylactic vaccine against COVID-19 in Malaysia
Milestone payments totaling $17.5 million upon approval by Malaysian Ministry of Health
Contracted royalty of $3 - $4.50 per dose of vaccine
Potential $150 million in GNBT revenues for vaccine sales in Malaysia
Potential to expand the partnership and development agreement in Australia, New Zealand, and the global HALAL markets
MIRAMAR, Fla., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) is pleased to announce that the company 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.
Under terms of the deal, Generex and Bintai have agreed to collaborate and have developed a strategy towards the rapid development of the Ii-Key-CoV-2 vaccine for Malaysia. As part of that strategy, Generex has identified a local CRO, Jigsaw Clinical Research Solutions (https://www.jigsawclinical.com/), managed by U.S. industry veteran, Jeffrey Yablon who has decades of experience in clinical development and regulatory affairs, and has established Jigsaw as the premier Malaysian CRO.
Generex CEO, Joseph Moscato said, “We want to thank our partners at Bintai for their commitment to develop our Ii-Key-SARS-CoV-2 “Complete Vaccine” against COVID-19. Our Ii-Key vaccine platform has always been about activation of the cellular immune system pathway via Ii-Key, which imparts long term memory through T-Helper cells. Our Ii-Key-SARS-CoV-2 vaccine strategy combines the Ii-Key T-Cell response with B-Cell epitopes that activate the humoral (antibody) response to deliver a Complete Vaccine for short and long-term protection from COVID-19. 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.”
Mr. Moscato continued, “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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