Femta Enters Into Manufacturing Services Agreement With Lonza

Femta Pharmaceuticals (Femta) and Lonza have entered into a manufacturing services agreement to facilitate the development and cGMP manufacturing of FM101. FM101 is a monoclonal antibody in late pre-clinical development for the treatment of Rheumatoid Arthritis.

FM101 is a monoclonal antibody directed against the cytokine interleukin 6 (IL-6). IL-6 is a multifunctional cytokine that regulates the immune, acute phase and inflammatory responses and has a direct role in hematopoiesis. FM101 targets IL-6 and neutralises its activity by preventing it from exerting its effect on various cells types in the body.

Reportedly, the agreement allows Femta access to Lonza’s GS Gene Expression System (GS: glutamine synthetase) along with cell line, purification and process development to support a robust cGMP process for Femta’s clinical development program.

Stephen Keane, president and COO at Femta, said: “We have chosen to work with Lonza for the cGMP production of FM101 our lead humanised anti IL (interleukin) 6 monoclonal development candidate as they are considered the leader in the expression and manufacture of monoclonal antibodies.

“FM101 is a femto molar binding antibody that we are developing for subcutaneous delivery in patients with autoimmune and inflammatory diseases. To facilitate our clinical program, we have begun our manufacturing development.

“We plan to submit an IND (investigational new drug application) and initiate a Phase I clinical trial in 2010. By leveraging Lonza’s considerable expertise in gene expression and antibody manufacturing, FM101 will have the additional benefit of speed, and yield optimization to further enhance the economies of scale for our antibody.”