French biopharmaceutical company LFB has received orphan drug status in Europe for their recombinant anti-CD20 monoclonal antibody as a treatment for chronic lymphocytic leukaemia.
Orphan drug status is granted to boost the development of treatments for rare and difficult diseases such as CLL, which represents 30% of cases of leukaemia in adults in Europe and is generally considered to be untreatable.
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 specific profile of the antibody has been demonstrated to have exceptional cytotoxicity in non-clinical trials, which suggest LFB-R603 could be more effective than the reference anti-CD20 antibody.
Phase I/II clinical trials for this indication of LFB-R603 are currently underway.