U.S. Patent Office issues Notice of Allowance to Antigen Express AE37 cancer vaccine

Generex Biotechnology Corporation (www.generex.com), together with its wholly-owned immunotherapeutic vaccines subsidiary, Antigen Express, Inc. (www.antigenexpress.com), announced today that Antigen Express has received a Notice of Allowance from the United States Patent Office relating to an application making augmentative pharmaceutical composition claims for the Antigen Express AE37 immunotherapeutic cancer vaccine.  The Company has previously received allowances of broad claims surrounding its Ii-Key hybrid technology, which was used in the design of the AE37 vaccine platform.  The current allowance strengthens independent composition of matter claims directed to the AE37 peptide. The full term of the new patent will extend through January 5, 2028.

AE37 is currently the subject of a randomized and controlled Phase II efficacy study in patients treated for breast cancer who are at high risk of recurrence. Favorable results from this study have been reported previously.  This immunotherapeutic vaccine also has been tested in a Phase I study in patients with prostate cancer, which confirmed the safety and immunogenicity observed in the prior breast cancer study.  In addition to breast and prostate cancer, many other types of cancer, such as lung, colon, stomach and bladder, also express the HER2 protein, which is the target for an AE37 stimulated immune response.