First-in-class antibody against Glycotope’s tumor-specific carbohydrate-protein epitope

PankoMab-GEX™ is the first potent fully human glycosylated and glyco-optimized therapeutic antibody against Glycotope’s novel carbohydrate-protein epitope of tumor associated MUC1 (TA-MUC1), which is expressed on the majority of tumor cells in a number of different cancers. The epitope comprises a tumor-specific carbohydrate antigen together with the immuno-dominant peptide region of MUC1, combining high tumor specificity, a high number of binding sites and affinity. It is abundantly present on primary tumors, metastases and cancer stem cells and virtually absent on normal cells. In the main target indications of ovarian, lung, breast and gastrointestinal tumors, over 90% of the tumor cells and more than 90% of patients carry the TA-MUC1 antigen. PankoMab-GEX™ expresses a series of potent anti-tumor mechanisms of action, including antibody-dependent cellular cytotoxicity (ADCC), tumor cell phagocytosis and induction of apoptosis, which are strongly enhanced by glyco-optimization through Glycotope’s GlycoExpress™ platform. This glyco-optimization is expected to result in better treatment outcomes compared to non-glyco-optimized biotherapeutics.

In a single agent Phase I trial in patients with progressive disease in various cancers. PankoMab-GEX™ was shown to be well tolerated, with no significant toxicities, in addition to demonstrating strong anti-tumor activity, including complete and partial responses with long-lasting disease stabilization.

In November 2013, Glycotope initiated a Phase IIb study with PankoMab-GEX™ as maintenance therapy for recurrent ovarian cancer. With the encouraging results seen as a single agent in the Phase I trial, the Company is also considering further development of PankoMab-GEX™ in additional indications.