Wacker Validates Scalability of Anticalin(R) Production With E.coli Secretion Technology and Will Produce Pieris First Clinical Candida...( FREISING-WEIHENSTEPHAN and JENA G...),Health

FREISING-WEIHENSTEPHAN and JENA, Germany, July 17 /PRNewswire/ -- Pieris AG, a bio-pharmaceutical company developing Anticalins(R), a novel class of targeted human protein therapeutics, and Wacker Biotech GmbH, a full-service contract manufacturer of biopharmaceuticals, announced yesterday a significant milestone in the development of Pieris' PRS-050 Anticalin(R) for clinical trials.

Pieris has developed PRS-050 as a next generation VEGF antagonist and as the first Anticalin(R) -based product in its proprietary pipeline. PRS-050 exemplifies many of the favourable characteristics of Anticalins(R): compact protein structure, high intrinsic stability, broad formulation flexibility and small molecular size improving the likelihood of effective target access. PRS-050 has already demonstrated potent inhibition of VEGF-induced enhanced vascular permeability and angiogenesis, as well as, anti-tumour activity and is expected to enter the clinic in 2009.

Wacker's proprietary E. coli secretion system is a well-established technology for the cost-efficient production of proteins. At the core of the technology is a proprietary E. coli K12-strain, developed by Wacker, to secrete recombinant proteins in native form. Production of clinically relevant proteins via direct extracellular secretion offers a far more cost effective approach to biopharmaceutical product manufacture than traditional protein refolding technologies.

Andreas Hohlbaum Ph.D., Chief Technology Officer of Pieris, stated: "Pieris has long-established expertise in small scale expression of Anticalins(R) for research use. As we progress our products to the clinic, we have established through our relationship with Wacker that an efficient production scale-up is possible. These excellent results and subsequent agreement with Wacker will expedite process development and GMP manufacture of Anticalins(R) for both proprietary and partnered products."

Thomas Maier Ph.D., Managing Director
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