Femta Pharmaceuticals and Lonza Group Ltd jointly announce the execution of a manufacturing services agreement to facilitate the development and cGMP manufacturing of FM101. FM101 is a high affinity monoclonal antibody in late pre-clinical development for the treatment of Rheumatoid Arthritis. 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.
“We have chosen to work with Lonza for the cGMP production of FM101 our lead high affinity humanized 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”, said Stephen Keane, President and COO, Femta Pharmaceuticals.
“We are pleased to be working with Femta Pharmaceuticals and to be supporting the development of this promising new compound for the clinical program”, added Stephan Kutzer, COO Lonza Custom Manufacturing. “Having Femta Pharmaceuticals selecting the GS Gene Expression System™ underlines the leading position of the system which is characterized by its speed and ease of use.”
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. IL-6 is produced by a number of cell types in the body and its hyper-production has been associated with autoimmune diseases and inflammation. FM101 targets IL-6 and neutralizes its activity by preventing it from exerting its effect on various cells types in the body. The activity of blocking the action of IL-6 has been shown to reduce disease severity in conditions like rheumatoid arthritis (RA) and Castleman’s disease.
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers’ needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets.
Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2008, Lonza had sales of CHF 2.937 billion. Further information can be found at www.lonza.com.
Femta Pharmaceuticals is focused on the development of best in class therapeutic monoclonal antibodies for the treatment of various disease states. Our monoclonal antibodies have applications in the areas of inflammation, autoimmune disease and oncology. Femta develops high affinity, high specificity monoclonal antibodies with improved effector functions as well as favorable safety and pharmacokinetic profiles. This is accomplished using proprietary protein engineering technology from BioAtla. The technology enables Femta to develop super high affinity humanized and/or human antibodies (sub pico molar to femto molar affinity) to potentially any target that meets our selection criteria. The high affinity of our antibodies will contribute to making our products more efficacious with better safety profiles, as well as potentially reducing drug dosage. Further information can be found at www.femtapharma.com
For further Information
Lonza Group Ltd
Head Corporate Communications
Tel +41 61 316 8624
Fax +41 61 316 9624
Lonza Group Ltd
Tel +41 61 316 8798
Fax +41 61 316 9798
Lonza Group Ltd
Tel +41 61 316 8540
Fax +41 61 316 9540
Stephen F. Keane
President and COO
+1 858 622-0424