Generex Biotechnology Corporation, a company focused on the research and development of drug delivery systems and technologies, has announced a follow-up study from its Phase I clinical trial of the immunotherapeutic agent AE37 in patients with prostate cancer.
Prostate cancer is the second most common cancer in men worldwide, and the 6th leading cause of cancer-related death. According to The American Cancer Society, prostate cancer affects 233,000 men every year in the United States alone.
In immunotherapy, prostate cancer is considered to be in the frontline, as it was the first indication for which an active systemic immunotherapy was granted approval by the FDA, with a number of immune-based cancer treatments currently being developed.
The study, entitled “AE37 peptide vaccination in prostate cancer: identification of biomarkers in the context of prognosis and prediction” and published in the peer-reviewed journal Cancer Immunology, Immunotherapy aimed to predict the immunologic and clinical responses of vaccination therapy with AE37, a modified HER-2/neu peptide developed using the Antigen Express Ii-Key technology platform, responsible for triggering robust and specific CD4+ T cell activation.
This peptide had already been used in the previous Phase I study in patients with prostate cancer and is currently being evaluated in a randomized Phase II trial to prevent recurrence in patients who have had breast cancer, a study that has showed promising results so far, especially in patients with low HER2 levels and in triple negative patients.
The researchers analyzed data resultant from immunologic determinations before, during and after primary series of vaccinations with AE37, observing that the levels of transforming growth factor beta (TGF-β) were inversely correlated with in vivo and in vitro immunologic responses to the AE37 vaccine, such as delayed-type hypersensitivity (DTH) and interferon gamma (IFN-γ) production in response to the peptide, significantly correlating with overall survival.
The current results are an important contribution towards the establishment of reliable biomarkers, one of the key aspects in cancer immunotherapy. Furthermore, they demonstrate an association between a specific immune response generated by AE37 and improved overall survival, paving the way in the evaluation of immunological and clinical responses to AE37-based vaccinations for multiple cancer indications, a technology being developed by Antigen Express, Inc. a wholly-owned subsidiary of Generex.