Generex Files for Phase 2 Trial of Keytruda Combo for Breast Cancer

Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the Company filed an investigational new drug application (IND) with the U.S. Food & Drug Administration (FDA) to initiate A Phase II Clinical Trial of Pembrolizumab (Keytruda®) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer. The trial, sponsored by Generex wholly-owned subsidiary Antigen Express, Inc. (www.antigenexpress.com) and conducted in conjunction with research partners Merck and the NSABP Foundation, Inc. (NSABP), is scheduled to initiate sites in the fourth quarter and to begin enrolling patients in the first quarter of 2019.

Dr. Eric von Hofe, President of Antigen Express, commented, “This is an important milestone in the development of AE37. Combining our promising immunotherapeutic with Merck’s checkpoint inhibitor Keytruda® (pembrolizumab) for the treatment of triple-negative breast cancer represents a novel treatment strategy for a cancer of high unmet need. Previous studies with each agent alone showed promising signs of efficacy. Their complementary mechanisms of action are particularly exciting and point to the importance of the current trial.”

Richard Purcell, Executive Vice President – Research & Development of Generex, commented, “This IND filing represents the culmination of a committed effort by the team at Antigen Express and our research partners at the NSABP Foundation. Antigen Express has been a pioneer at the forefront of immuno-oncology for over a decade with our Ii-Key platform that ensures CD4 T-cell activation against any tumor antigen to which the Ii-Key is attached. We are advancing this technology with our lead product AE37 for breast cancer, but also for the treatment of prostate and potentially other cancers that express even low levels of HER2/neu. The Ii-Key platform holds great promise, and we plan to explore collaborations and partnerships in the field of personalized immuno-oncology to maximize value for our investors.”

https://www.biospace.com/article/releases/generex-biotechnology-announces-ind-filing-for-a-phase-ii-clinical-trial-of-ae37-in-combination-with-pembrolizumab-keytruda-for-the-treatment-of-triple-negative-breast-cancer/