Generex Biotechnology Corporation confirmed its receipt of the USD 700,000 up-front license fee payable by Shenzhen BioScien Pharmaceuticals Co. Ltd. under the License and Research Agreement entered into with Generex wholly-owned subsidiary Antigen Express Inc. The purpose of the Agreement is 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). 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. In addition to the license fee, under the Agreement Shenzhen BioScien will also make milestone payments to Generex of USD 1,000,000 each upon completion of the Phase II and Phase III clinical studies of the vaccine as well as a milestone payment of USD 2,000,000 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.