Swedish Orphan Biovitrum promotes Removab® in the Nordic region, in the Baltics and in central and Eastern Europe (in total in 15 countries) under a collaborative agreement with Fresenius Biotech.
Removab is a trifunctional antibody that is indicated for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible. Treatment with Removab and paracentesis (drainage of fluid following the active puncture of the peritoneum) has been shown to result in a clinically relevant and statistically significant improvement compared with paracentesis alone, as demonstrated by increases in puncture free survival and time to next puncture.
The mechanism of action of Removab is based on the properties of the trifunctional antibody that specifically binds to EpCAM-positive malignant cells and the CD3 antigen on T-cells. Additionally, a third functional binding site in the Fc-region enables interaction with accessory immune cells such as macrophages and natural killer cells. Bringing tumor cells, T-cells and accessory immune cells in close proximity triggers a complex “crosstalk” between the immune cells (including cytokine release and co-stimulatory signaling necessary for a physiological T-cell activation cascade) resulting in the elimination of tumor cells.
The elimination of tumor cells is the main reason for the efficacy of Removab, providing significant improvement both in puncture-free survival and in puncture-free interval for patients with malignant ascites.