Generex Provides Update on its Ii-Key COVID-19 Complete Vaccine Program: Advancing Global Development

Rhea-AI Summary

Generex Biotechnology Corporation (OTCQB:GNBT) has secured a $2 million payment from its Chinese partners to assist in the IND submission process for its Ii-Key-SARS-CoV-2 Vaccine to the NMPA. This partnership involves prominent Chinese institutions for the development and regulatory approval of the vaccine in China. Generex will provide necessary research data and documentation as part of the collaboration, aimed at expediting the vaccine’s regulatory process. The company retains rights to the vaccine outside China and anticipates a supportive regulatory environment for the submission.

Positive

• Secured a $2 million payment from Chinese partners.
• Accelerated IND submission for Ii-Key-SARS-CoV-2 Vaccine in China.
• Collaboration with significant Chinese institutions enhances credibility.
• Retains global rights to the vaccine outside of China.

Negative

• None.

• Generex receives $2 million payment from Chinese partners to provide research results, data, and necessary documents to support an IND submission to the Chinese National Medical Products Administration (NMPA)

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 disease (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.”

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.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:

Generex Biotechnology Corporation

Joseph Moscato
646-599-6222

Todd Falls
1-800-391-6755 Extension 222

investor@generex.com

FAQ

What is the significance of Generex's $2 million payment from Chinese partners?

The $2 million payment will enable Generex to provide essential research and regulatory documentation for the IND submission of its Ii-Key-SARS-CoV-2 Vaccine to the NMPA in China.

What is the role of Generex in the development of the Ii-Key-SARS-CoV-2 Vaccine?

Generex will coordinate technology transfer and provide necessary research data, regulatory documents, and manufacturing methods to support its Chinese partners in the vaccine's development.

Which organizations are involved in the partnership with Generex?

The partnership includes the National Institute for Viral Disease Control and Prevention, Beijing Youfeng International Consulting Co., Ltd, and Beijing Guoxin Haixiang Equity Investment Partnership.

How does this partnership affect the timeline for the vaccine's approval?

The collaboration aims to expedite the regulatory process, with expectations that the NMPA will fast-track the IND submission once received.

What rights does Generex retain regarding the Ii-Key-SARS-CoV-2 Vaccine?

Generex maintains exclusive rights to the Ii-Key-SARS-CoV-2 Vaccine outside of China.