EMEA grants orphan drug status for LFB Biotechnologies' recombinant anti-CD20 monoclonal antibody

The recombinant anti-CD20 monoclonal antibody produced by LFB Biotechnologies received orphan drug status for the treatment of Chronic Lymphocytic Leukemia (CLL). This approval from the EMEA’s Committee for Orphan Medicinal Products (COMP) was handed down on last October 7^th.

Chronic Lymphocytic Leukemia represents 30% of cases of leukemia in adults in Europe. Though its cause remains unknown, it is characterized by the proliferation of B lymphocytes that migrate into the lymph nodes, spleen and liver and invade the bone marrow and blood. This can lead to anemia and/or thrombocytopenia (drop in platelet count) and induces an immunocompromised state in patients, thus increasing the risk of severe infections.
CLL is a serious disease with mean survival of 10 to 12 years following its diagnosis. Patients are usually diagnosed between the ages of 65 and 70 years. The condition is rarely detected before the age of 30. Around 60,000 new cases of the disease are detected each year in Europe, with 8000 in France. Until now, CLL has been considered to be an incurable disease.

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 glycosylation profile of LFB-R603 gives it powerful ADCC (antibody-dependent cell-mediated cytotoxicity) activity against the tumor cells carrying this antigen. This exceptional 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, and thus constitute a major breakthrough in the treatment of Chronic Lymphocytic Leukemia. LFB-R603 is currently under study in a phase I/II clinical trial for this indication.

Source LFB Biotechnologies