« First in man » for two LFB monoclonal antibodies
First in man injections of LFB’s first two therapeutic monoclonal antibodies
The French biopharmaceutical group LFB has announced the first-in-man injections of its first two therapeutic monoclonal antibodies and the filing of BLAs for a newgeneration immunoglobulin and a fibrinogen.
During Q4 2008, two monoclonal antibodies developed by LFB’s R&D division (an anti-D monoclonal and a batch of anti-CD 20) both achieved a significant development milestone – first-in-man administration.
The anti-D monoclonal (ADNC) is used in cases of rhesus incompatibility between a mother and her fetus. In France, this type of allo-immunization prevention concerns over 150,000 rhesus-negative women each year. The Phase I safety and pharmacokinetic trial of ADNC is currently being performed in healthy volunteers. A Phase II efficacy trial will be performed at a center in Europe in the second half of 2009. In this indication, only polyclonal plasma immunoglobulins are currently available worldwide.
The anti-CD 20 targets a B lymphocyte surface antigen that is expressed in leukemia and lymphoma. The antibody is potentially indicated as a component in the therapy of rare cancers. The biomanufacturing company MAbgène (acquired by the LFB group in 2007 and located in Alès, southern France) has produced the batches needed to run the anti-CD20’s initial clinical development program. The Phase I trial is currently investigating lymphoid leukemia patients at seven centers in France (led by the Institut Gustave Roussy cancer center near Paris).
In the field of plasma-derived drugs, LFB also filed (in late 2008) a biological license application for a new-generation, polyvalent human immunoglobulin that is produced in a completely new process. In parallel with the development of this new drug, LFB has invested significantly at its facilities in Les Ulis (near Paris) and Lille (in northern France), in order to double its manufacturing capacity by 2011 and thus meet patients’ growing therapeutic needs for immunoglobulins, in particular. A new manufacturing unit (with a capacity of 5.6 metric tons and to be fully dedicated to production of this novel immunoglobulin) is currently being qualified at the group’s Lille site. LFB’s new nanofiltered fibrinogen is also likely to gain marketing authorization later this year.
About LFB:
LFB is a pharmaceutical company, the first French company in the biotech field, the fifth largest pharmaceutical company in plasma-derived medicinal products, and the third laboratory supplying drugs to hospitals in France. LFB commercializes a wide range of 19 plasma-derived medicinal products addressing more than 80 pathologies in three therapeutic fields: Immunology, Homeostasis, and Intensive Care. Each year in France, 500,000 patients are treated with LFB’s products for chronic pathologies or for emergency cases. In the biotechnology field, LFB develops monoclonal antibodies and a line of therapeutic proteins through transgenic technology with GTC Therapeutics.
Press Contact:
Sandrine Charrières – Communications Director
Tel: +33 (0)1 69 82 72 80
Email: charrieres@lfb.fr