LFB’s Recombinant Anti-CD20 Monoclonal Antibody Receives Orphan Drug Status In Europe

LFB Biotechnologies’ (LFB) recombinant anti-CD20 monoclonal antibody received orphan drug status for the treatment of chronic lymphocytic leukemia (CLL).

The company received the approval from the EMEA’s Committee for Orphan Medicinal Products (COMP) on October 7, 2009.

LFB’s anti-CD20 antibody (LFB-R603) is a chimeric recombinant monoclonal antibody directed towards the CD20 antigen expressed on the surface of B cells.

The company sated that the specific glycosylation profile of LFB-R603 gives it powerful ADCC (antibody-dependent cell-mediated cytotoxicity) activity against the tumor cells carrying this antigen.

This cytotoxicity has been demonstrated in non-clinical trials performed in vitro and in vivo and LFB-R603 could be more effective than the reference anti-CD20 antibody.

LFB-R603 is currently under study in a phase I/II clinical trial for this indication.