Worcester, Massachusetts-based drug developer Generex Biotechnology Corporation recently announced that the company has published follow-up study data from its Phase 1 clinical trial for treating prostate cancer with its immunotherapeutic agent AE37, a compound that is being developed by Antigen Express, Inc., Generex’s wholly owned subsidiary. The company is reporting that data from the study has demonstrated a connection between a specific immune response that AE37 creates and an improved rate of overall survival in study participants.
The study, which is entitled, “AE37 peptide vaccination in prostate cancer: identification of biomarkers in the context of prognosis and prediction,” was recently published online in the peer-reviewed journal Cancer Immunology, Immunotherapy, a journal that publishes new findings relating to basic, translational, and clinical science involving cancer immunology and immunotherapy. The new study not only reinforced findings from a previous prostate cancer-related study demonstrating that patient groups immunized with AE37 experienced a higher rate of overall, disease-free survival versus normal expectations, but also that that patient performance was directly related to the level of immunological response. According to a company press release, “both the presence of AE37-induced T cells in peripheral blood as well as a robust delayed type hypersensitivity (DTH) response elicited by AE37 correlated significantly with overall survival. The authors point out the importance of CD4+ T cells in developing a good DTH response. AE37 was developed using the Antigen Express Ii-Key technology platform that ensures robust, specific CD4+ T cell activation.”
While the subject of this current trial is treating prostate cancer, AE37 has also showed promise in other indications as well. A previous controlled, randomized Phase 2 trial tested the experimental therapy in preventing cancer recurrence in breast cancer patients — the data of which revealed that AE37 decreased the occurrence of relapse in patients, particularly for those patients who had decreased levels of HER2 expression, as well as those with triple negative breast cancer. Given the fact that identifying reliable biomarkers is a primary in cancer immunotherapy, the current study involving AE37, in addition to previous data, is contributing to the development of new biomarkers. And since AE37 is designed for multiple cancer indications, the early results bode well for future cancer-related clinical trials.