Phase 2 study of AE37 vaccine for breast cancer

Generex Biotechnology announced two presentations of data obtained from its on-going Phase 2 trial of its novel immunotherapeutic AE37 vaccine in breast cancer patients. The first presentation on combination immunotherapy reports that patients receiving both AE37 and Herceptin (trastuzumab, from Genentech), a monoclonal antibody targeting the same protein, have increased specific immune-stimulation of T cells when AE37 is given simultaneous to administration of trastuzumab rather than following trastuzumab treatment. These results confirm prior published reports suggesting that the combination of trastuzumab with active immunotherapy can work synergistically in cancer patients.

The second presentation reports that patients who are genetically predisposed to less efficiently recognize peptides derived from the HER2 protein have an immunological response to the AE37 HER2 peptide vaccine that is similar in robustness to the response in patients not having this predisposition.  This is promising confirmation that AE37, which is designed as a self-potentiating peptide vaccine, indeed has improved activity that may be clinically relevant.

AE37 is designed to increase immune response. This design specifically increases the ability of CD4+ T helper cells to recognize HER-2/neu expressing cancer cells in immunized patients, which should prompt the immune system to mount a robust anti-cancer response.

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