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Generex Provides an Overview of its Cancer Immunotherapy Product, AE37, and Potential in Early Breast Cancer Given Current and Potential Future Therapies
Date:1/30/2013

ential advantage is that the immunological memory induced by AE37 means the immune system may continue to scan for and kill HER2 cancer cells long after AE37 treatment has been completed.

Herceptin is approved for metastatic and early stage breast cancer patients. Its 2010 annual sales were nearly $6B. Given that the initial target population for AE37 in early stage breast cancer patients is twice that of Herceptin, AE37 has the potential to achieve blockbuster status.

The potency of AE37 derives from a fragment of the HER2 protein combined with a proprietary modification developed at Antigen Express. While similar fragments of HER2 are also in clinical development for early stage breast cancer patients with low HER2 expression, they lack the potency of AE37. Further, their mechanism of action requires use to be limited to a sub-group of people with a specific genetic immune type. The clinical use of these alternative HER2 immune fragments therefore must exclude roughly half of the women with early breast who would otherwise be eligible. No genetic immune limitation or exclusion from clinical use is required for AE37 treatment. Any market competition in early breast cancer from these alternate HER2 fragments would be limited to the genetic immune sub-group, with AE37 facing no competition in patients excluded from other treatments. Further, additional genetic immune profile testing adds another diagnostic step before a woman with early breast cancer could get a potential new treatment. Any agents requiring additional testing may be at a competitive disadvantage.

Another advantage that sets AE37 apart from other types of related vaccines is that it contains a proprietary modification that is exclusive to Antigen Express. The modification, termed Ii-Key, derives its name from the immune regulatory molecule from which it is derived (Ii protein) and the fact that it functions as a 'key' to deliver its payload (HER2 fragment) to critical components
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SOURCE Generex Biotechnology Corporation
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