MIRAMAR, Fla., May 05, 2021 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (“Generex” or the “Company”), an innovative and integrated healthcare holding company with end-to-end solutions for patient centric care including the development of its innovative “Complete Vaccine” to fight SARS-CoV-2, today provided guidance on the terms of its agreement with Beijing Youfeng Biological Technology, Ltd (Youfeng-BI) in connection with the $2,000,000 payment made by Youfeng-BI to GNBT and its subsidiary NuGenerex Immuno-Oncology, Inc. (NGIO) on or about April 27, 2021. Under the terms of this agreement:
If YouFeng-BI conducts phase I, phase II, phase III clinical trials in accordance with ICH guidelines to support commercial approval of the Ii-Key SARS-Cov-2 vaccine by the NMPA (the Chinese FDA), then:
(1) YouFeng will provide the clinical data to Generex for its US FDA and the international approvals in its current contracts as available; and
(2) YouFeng shall have the exclusive sales rights in any country other than US, Canada and the countries, territories under GNBT’s current licensed out contracts, and Mexico, Ecuador, Peru and Colombia with respects to li-key SARS-Cov-2 vaccine (provided that YouFeng complies with clauses (1) and makes a commitment to execute clause (3) of this paragraph); and
(3) Upon the technology is recognized by NMPA through this li-key SARS-Cov-2 vaccine, YouFeng will execute the payment terms of license fee for the entire Ii-key platform referred to in a contract previously executed by GNBT.
Although YouFeng will obtain the exclusive sales rights mentioned above upon the satisfaction of the conditions mentioned above, Generex and NGIO will maintain worldwide patent rights to the Ii-Key SARS-Cov-2 vaccine, except for China.
Additionally, Youfeng has agreed to provide GNBT with (i) a complete development plan outlining the regulatory path, data requirements, pre-clinical and clinical studies planned, and regulatory filing timeline and (ii) copies of all NMPA filings to date and in the future.
Generex CEO, Joseph Moscato said, “We are pleased that our Chinese partners have paid Generex $2 million dollars for our vaccine development expertise which will subsidize the costs of research, development, and technology transfer in support of their NMPA submission, and we look forward to the approval of the Ii-Key Complete Vaccine.”
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.
If YouFeng-BI conducts phase I, phase II, phase III clinical trials in accordance with ICH guidelines to support commercial approval of the Ii-Key SARS-Cov-2 vaccine by the NMPA (the Chinese FDA), then:
(1) YouFeng will provide the clinical data to Generex for its US FDA and the international approvals in its current contracts as available; and
(2) YouFeng shall have the exclusive sales rights in any country other than US, Canada and the countries, territories under GNBT’s current licensed out contracts, and Mexico, Ecuador, Peru and Colombia with respects to li-key SARS-Cov-2 vaccine (provided that YouFeng complies with clauses (1) and makes a commitment to execute clause (3) of this paragraph); and
(3) Upon the technology is recognized by NMPA through this li-key SARS-Cov-2 vaccine, YouFeng will execute the payment terms of license fee for the entire Ii-key platform referred to in a contract previously executed by GNBT.
Although YouFeng will obtain the exclusive sales rights mentioned above upon the satisfaction of the conditions mentioned above, Generex and NGIO will maintain worldwide patent rights to the Ii-Key SARS-Cov-2 vaccine, except for China.
Additionally, Youfeng has agreed to provide GNBT with (i) a complete development plan outlining the regulatory path, data requirements, pre-clinical and clinical studies planned, and regulatory filing timeline and (ii) copies of all NMPA filings to date and in the future.
Generex CEO, Joseph Moscato said, “We are pleased that our Chinese partners have paid Generex $2 million dollars for our vaccine development expertise which will subsidize the costs of research, development, and technology transfer in support of their NMPA submission, and we look forward to the approval of the Ii-Key Complete Vaccine.”
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.
1
