Generex highlights pipeline potential of Antigen Express subsidiary

Canada-based Generex Biotechnology (OTC Bulletin Board: GNBT) last week provided an overview of the current pipeline and potential of its wholly-owned US subsidiary Antigen Express, which a couple of years ago the firm said it planned to spin-out as a separate DTC-eligible Securities and Exchange Commission-registered company valuing the asset at around $300 million (The Pharma Letter April 1, 2011). In September 2012, the parent said that it is proceeding with the previously-announced spinout of Antigen Express.

While Antigen is currently in a late Phase IIb trial of a very promising new immunotherapy for early breast cancer (AE37), the company has made concrete headway in demonstrating a robust pipeline for AE37, its lead compound, indications beyond breast cancer, as well as for the technology behind it.

Immediately behind its Phase III-ready breast cancer program, Antigen has completed a Phase I prostate cancer trial and established a protocol for Phase II. While Roche’s blockbuster cancer drug Herceptin (trastuzumab) targets the same tumor-associated protein as does AE37 therapy, Herceptin is not approved for breast cancer patients with low levels of HER2 expression, limiting Herceptin treatment to roughly 25% of breast cancer patients, notes Generex. Low levels of HER2 protein have been shown on several cancers, including men with prostate cancer. AE37 is being further researched in this larger population of patients whose tumors express only low levels of HER2.