Our first-in-class antibody against a tumor-specific carbohydrate-protein epitope.
Gatipotuzumab (previously known as PankoMab-GEX®) a novel, proprietary, highly specific anti-tumor antibody developed through Glycotope’s proprietary glyco-epitope targeting and glycooptimization technologies. It has potential across a number of cancer types and as a platform for the development of multiple further oncology and immuno-oncology products including bi-specifics targeting immune system effects. Gatipotuzumab enables tumor-specific binding to a novel carbohydrate-induced conformational epitope, the TA–MUC1 (tumor-associated MUC1), which is present in the majority of cases across a variety of high prevalence carcinomas.
A randomized double blinded study in ovarian cancer has been recently completed and reported*; Gatipotuzumab did not improve the time without disease recurrence when given as single agent maintenance, while showing a good safety profile. Additional studies are planned to assess the potential of Gatipotuzumab when used in combination with other agents in different tumor types and settings.
Disease setting, and the opportunity
Gatipotuzumab (previously known as PankoMab-GEX®) is currently under development for recurrent ovarian cancer. Target indications for further development include non-small cell lung (NSCLC), breast, gastrointestinal, pancreatic, endometrial and cervical cancers.
In these target indications, most patients carry the TA–MUC1 antigen.
Key Trials and Data
In a Phase 1 dose escalation study, single agent Gatipotuzumab was well tolerated and showed promising therapeutic activity in patients with various solid tumors, including complete and partial responses and long lasting disease control.
In November 2013, Glycotope initiated a Phase 2 study with Gatipotuzumab as maintenance therapy for recurrent ovarian cancer. The recruitment phase for this study has recently been completed. The results from this study are expected for mid-2017.
Differentiation/mode of actions/specificity
The TA–MUC1 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. Gatipotuzumab works via 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.