Generex Biotechnology Corporation announce that the final results of the Phase IIb clinical trial of AE37 +/- GM-CSF vaccine for the prevention of recurrence of breast cancer have been published in the peer-reviewed journal, Breast Cancer Research & Treatment. In the AE37 arm of this trial, the investigators found that patients with advanced stage, HER2 under-expression, and TNBC may benefit from AE37 vaccination, and those with both advanced stage and HER2 under expression have a significant clinical benefit to AE37 vaccination, demonstrating earlier DFS plateau that was maintained for up to the ten years of follow-up. The study showed that AE37 induces CD4+ T helper cell stimulation which is required for the effective generation of long-term cell-mediated immunity, and postulates that the AE37 vaccine may have more of an immunoadjuvant effect to augment a vaccine-induced CD8+ T-Lymphocyte (CTL) response. Further, AE37 is able to directly stimulate the HLA-DR alleles with epitopes present in the HER2 protein, increasing interferon gamma (IFN-?) and CD4+ T-helper (Th1) cells which in turn assist in strong in vivo autologous lysing of tumor cells by CD8+ cells. Thus, the addition of the Ii-Key in AE37 specifically enhances immune responses via the MHC class I pathway. Additionally, the study shows that the Ii-Key acts as an immune system adjuvant, activating both the CD4+ response and the CD8+ response against the HER2 antigenic epitope to which it is attached. The authors point out the benefit of such a complete immune response that combines CD8+ and CD4+ activation may not only induce an immediate cell mediated cytolytic response versus tumor cells but may also induce T-Helper cell mediated long-term immunity to protect against tumor recurrence.