Generex Provides Update on its Ii-Key COVID-19 Complete Vaccine Program: Advancing Global Development
MIRAMAR, Fla., April 27, 2021 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that in connection with its partnership with the National Institute for Viral Disease Control and Prevention, Chinese Centre for Disease Control and Prevention, Beijing Youfeng International Consulting Co., Ltd and Beijing Guoxin Haixiang Equity Investment Partnership, the company has received a $2 million development payment from Beijing Youfeng Biological Technology, Ltd (Youfeng-BI). In exchange for this payment, Generex will provide to Youfeng-BI and our Chinese partners research results, data, regulatory documents, and manufacturing methods to support the filing of an Investigative New Drug (IND) application for the Ii-Key-SARS-CoV-2 Vaccine in China. Pursuant to the partnership, the company’s partners in China are responsible for the development and regulatory approval of the Ii-Key COVID Vaccine by the NMPA in China. All clinical trials will be conducted under guidelines of the International Council on Harmonisation (ICH), so the data can be used for submission to FDA, EMEA, and other international regulatory agencies; Generex Biotechnology Corporation and NuGenerex Immuno-Oncology maintain the rights to the Ii-Key-SARS-CoV-2 Vaccine in the rest of the world outside China.
Generex will coordinate technology transfer with the Chinese partners to facilitate research and development efforts required to achieve the commercial approval of a Complete Vaccine™ in China. 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 diease (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. NuGenerex Immuno-Oncology (NGIO) has filed for and expects to receive a trademark for The Complete Vaccine™ and has filed patent applications for the Ii-Key-SARS-CoV-2 Vaccine and Ii-Key Vaccine platform.
Generex CEO, Joseph Moscato said, “We are pleased that our Chinese partners have advanced Generex $2 million additional dollars to provide our vaccine development expertise and to subsidize the costs of research, development, and technology transfer in support of their NMPA submission. Generex has provided the requested materials and regulatory documentation which is currently being translated into Chinese for the IND submission that has been fast-tracked by the NMPA. Given the global need for new COVID vaccines, our Chinese partners believe the regulatory process and path to approval will be expedited once the IND is submitted.”
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