Basel, Switzerland, 5 March 2009 – TcL Pharma and Lonza have recently signed a development and supply contract for TcL Pharma’s lead drug candidate, an innovative monoclonal antibody that adjust the immune system, and a compound that would treat graft rejections and help patients with auto-immune diseases, if approved.
The long-term service agreement includes strain development using Lonza’s proprietary XS Microbial Expression TechnologiesTM through to cGMP manufacture of Phase I clinical material.
“We choose Lonza for their extensive know-how and experience in the development and scale-up of microbial biopharmaceuticals,” said Maryvonne Hiance, President of TcL Pharma. ”We look forward to working with such a trusted name in custom manufacturing and are confident that it will lead to positive results.”
The first phase of the project will encompass strain development using Lonza’s patented E. coli expression technology, followed by microbial process development and optimization activities to help achieve the highest yields possible, increase speed to market, and lower the total cost of goods. Subject to several project milestones, Lonza will then produce the bulk drug substance in its state-of-the-art 1,000 L microbial biopharma facility in Visp, Switzerland for toxicological studies and a phase I clinical trial.
“We are looking forward to a long-standing relationship with a promising, innovative company developing new therapies for patients in need,” said Dr. Stephan Kutzer, Head of Lonza Biopharmaceuticals.
TcL Pharma’s compound, a PEGylated anti-CD28 Fab, is a therapeutic antibody fragment designed to selectively inhibit T-cell responses against grafts. The molecule is a novel antagonist of the human CD28 receptor, an important co-stimulatory protein expressed on T-cells. Promising preliminary results indicate that this molecule will be administered for the treatment of graft rejection and auto-immune diseases.
About Lonza
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 SWX Swiss Exchange. In 2008, Lonza had sales of CHF 2.94 billion. Further information can be found at www.lonza.com.
About TcL Pharma:
TcL Pharma is a biotech company dedicated to the discovery and the development of drugs which regulate the immune system in organ and tissue transplantation and in autoimmune disease. Based in Nantes (France), TcL Pharma is a spin-out from company ITERT (Institut de Transplantation et de Recherche en Transplantation), Europe’s number one kidney and pancreas transplant centre. The company’s expertise covers the various steps in drug development, from discovery through to Phase II clinical trials via proof of concept, preclinical work and Phase I clinical trials. Within as little as 2 to 4 years, TcL Pharma aims to generate revenues from strategic agreements with suitable big pharma firms and/or mature biotech companies. TcL Pharma will establish contacts with these companies at the preclinical stage of drug development, with a view to the signature of alliances after Phase II clinical trial results have been generated. In parallel, TcL Pharma will generate revenues from the sales of partners companies’ products through compassionate use programmes.
Further information can be found at www.tcl-pharma.com
