On December 7, 2017 Generex Biotechnology Corporation (OTCQB:GNBT) (View Source) (www.generex.com) reported that its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), has entered into a License and Research Agreement with Shenzhen BioScien Pharmaceuticals Co. Ltd. www.BioScien.cn to develop and commercialize the Antigen Express AE37 immunotherapeutic vaccine for prostate cancer in the People’s Republic of China (including Taiwan, Hong Kong, and Macau) (Press release, Generex, DEC 7, 2017, View Source [SID1234522511]).
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"We are pleased to be able to include this in our innovative pipeline of novel therapeutics."
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A previously completed Phase I study of the vaccine conducted by Antigen Express in patients with prostate cancer demonstrated robust, long-term, and specific activation of cancer-fighting T cells in immunized patients.
Shenzhen BioScien will pay Generex a non-refundable, up-front license fee of $700,000 USD. Under the Agreement, Shenzhen BioScien will also make milestone payments to Generex of $1,000,000 USD each upon completion of the Phase II and Phase III clinical studies of the vaccine as well as a milestone payment of $2,000,000 USD upon regulatory approval of the vaccine in the territory. Generex will also receive a 10% royalty on net sales of the product.
Under the Agreement, Shenzhen BioScien has responsibility for paying for and conducting the clinical trials, securing Chinese regulatory approvals, and the manufacturing, marketing, distribution, and sale of the product. The clinical trials will be designed and conducted so as to meet the regulatory requirements of the U.S. Food and Drug Administration and the European Medicines Agency and Antigen Express will have free access to all data for support of global regulatory filings and further development and commercialization initiatives outside the licensed territories.
The AE37 vaccine is designed using a proprietary technology platform that ensures a more robust and long-lasting immune response than would be possible otherwise. In addition to the Phase I prostate study, the clinical activity of AE37 has been demonstrated in a controlled, randomized Phase II study in 300 breast cancer patients. Based on encouraging efficacy data from that study, the Company has entered into an agreement with Merck (d.b.a. as Merck Sharp & Dohme outside the United States and Canada) to evaluate Antigen’s AE37 cancer vaccine in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with metastatic triple-negative breast cancer.
"We are delighted that Shenzhen BioScien will continue development of AE37 for prostate cancer," said Joe Moscato, President & Chief Executive Officer of Generex. "AE37 is the lead compound being developed using our Antigen Express technology platform. The clinical studies conducted to date establish the wide applicability of AE37 and its underlying Ii-Key technology. This license, together with the Merck collaboration, highlights the value of the core assets of Generex as we reinvigorate those assets in the wake of our recently completed reorganization."
"The AE37 cancer vaccine has shown impressive results in clinical trials," said Dr. Yinke Yang, Chief Executive Officer of Shenzhen BioScien. "We are pleased to be able to include this in our innovative pipeline of novel therapeutics."