Samarbetet mellan Wacker Biotech och Metheresis: ESETEC ® ökar utbytet av Mv-DN30, ett anti-MET antikroppsfragment för att bekämpa cancer

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Munich/Jena, January 13, 2013 – Wacker Biotech and Metheresis Translational Research, a biotech company of the Italian phar-maceutical group Sigma-Tau, have reached a major milestone in their collaboration on the production of Metheresis’ drug candi-date Mv-DN30, an anti-MET Fab antibody fragment. With the aid of ESETEC®, WACKER's proprietary secretion technology, WACKER has developed an efficient cell line for the production of Mv-DN30. A study has shown that E. coli-based ESETEC® is capable of delivering much higher yields of the recombinant tar-get product than conventional technologies. The resultant anti-body fragment, a chimeric, engineered monovalent format of the anti-MET antibody DN30, is a highly promising new cancer drug. The product is currently being developed by Metheresis and has already shown distinctive pharmacological properties and very good results in animal tests.

In its search for an efficient process capable of producing the Fab antibody fragment on an industrial scale, Metheresis turned to WACKER for assistance. WACKER conducted a study which not only confirmed the feasibility of producing the novel cancer drug with WACKER's proprietary ESETEC® technology. It also delivered high yields of correctly folded, fully functional antibody fragment in the culture broth that could be easily purified, thus enabling the supply of highly pure product for further development.

Fab antibody fragments are composed of two different protein sub-units and contain both intramolecular and intermolecular disulfide bridges. This makes their production much more challenging than that of many other biopharmaceuticals. However, the study found that yields obtained with ESETEC® were 50 times those obtained with traditional production technologies. This is a milestone for WACKER and Metheresis/Sigma-Tau because both a suitable ESETEC® cell line and an initial purification process are now available that will en-able WACKER to produce the antibody fragment and Metheresis to continue developing the monovalent anti-MET cancer drug.

Fab antibodies are purpose-made constituents of human antibodies and are believed to offer great promise as novel active pharmaceuti-cal substances for disease treatment. Their advantages over whole antibodies are chiefly their greater ability to penetrate into tissues and their cost-effective production in microbial systems. MET is the recep-tor for the hepatocyte growth factor and is essential for proper embry-onic development. Under certain pathological conditions, however, MET signals are responsible for tumor formation and metastasis. Since the novel antibody fragment Mv-DN30 blocks MET signals in tumors, it is a promising candidate for cancer treatment.

ESETEC® is a WACKER-proprietary technology with a track record of cost-effective production of proteins and antibody fragments. It is based on an E. coli K12 strain which has a particular ability to secrete recombinant proteins into the culture broth in the correct folding con-formation. Secretion into the broth facilitates purification of the target protein, since complicated process steps such as homogenization and refolding are unnecessary. This makes the entire manufacturing process significantly more efficient and cost-effective. A number of biopharmaceuticals that have been manufactured via ESETEC® are already being evaluated in preclinical and clinical studies.

"We are delighted with the successful collaboration with Metheresis and Sigma-Tau," said Dr. Thomas Maier, Managing Diretor of Wacker Biotech. "We are very proud that our innovative ESETEC® technology is gaining in acceptance and so enabling our customers to make a major contribution to the development of novel cancer therapy drugs."

Alessandro Noseda, Board Member of Metheresis, confirmed: "Im-provement of productivity of our recombinant anti-MET antibody fragment, obtained with WACKER’s ESETEC®, is going to be funda-mental to plan further industrial development of the product".

Pietro Grossi, R&D Director of Sigma-Tau, highlighted that "in light of its potential therapeutic role, Mv-DN30 is an important asset within the Group pipeline, and the access to highly efficient, state-of-the-art technologies such as ESETEC® provides additional value".

About Wacker Biotech

Wacker Biotech GmbH is a full-service contract manufacturer of bio-pharmaceutical products based on microbial systems. Services at the company’s certified multi-purpose site in Jena range from the field of molecular biology to comprehensive analytical services and process development, through the GMP-compliant production of clinical test samples as well as pharmaceuticals for the commercial market. Above all, Wacker Biotech offers proprietary technologies that satisfy market needs for cost-efficient production and maximum quality. Je-na-based Wacker Biotech is a wholly-owned WACKER subsidiary.

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About Metheresis Translational Research S.A.

Metheresis Translational Research S.A. is a Swiss biotech company with the mission of identifying and developing proprietary innovative therapies in oncology. Metheresis is a company of the Sigma-Tau Group.

About Sigma-Tau

Founded in 1957, Sigma-Tau is an international, privately owned pharmaceutical company, involved in research and development, manufacturing, production, sales and marketing of pharmaceuticals and nutritional supplements. In 2011 the Sigma-Tau Group reached total sales of 662.7 million €. It is a primary player in Europe, with a direct presence also in the USA (increased in 2010 by the acquisition of Enzon "specialty care" business) and Asia (India and China), and a consolidated network of licensees in the rest of the world.

Sigma-Tau’s most recent R&D efforts have been focused on a num-ber of main lines, such as immune-oncology integrated approaches to cancer therapy, as well as medicines for rare and neglected diseases, carnitine biological system and product line extensions.

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Wacker Chemie AG

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Företaget i överblick: WACKER är en globalt verksam kemikoncern med cirka 17 200 anställda och en årsomsättning på cirka 4,91 miljarder € (2011). WACKER har 25 produktionsanläggningar, 20 technical competence centers och 53 försäljningskontor över hela världen.

WACKER SILICONES Silikonoljor, silikonemulsioner, silikongummi och silikonhartser, silaner, pyrogena kiselsyror, termoplastiska silikonelastomerer

WACKER POLYMERS Polyvinylacetat- och vinylacetat-kopolymerer i form av dispersionspulver, dispersioner och fasthartser som bindemedel för byggkemiska produkter, färger, lim, lacker, putser och fiberdukar samt i polymera material baserade på återvinningsbara resurser.

WACKER BIOSOLUTIONS Bioteknologiska produkter såsom cyklodextriner, cysteiner och biologiska produkter liksom fiinkemikalier och PVAc fasta hartser

WACKER POLYSILICON Polysilicium för halvledar- och fotovoltaikindustrin

Siltronic Wafers av högrent silicium och enkristaller för halvledarkomponenter.