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Pieris AG

Pieris reports preclinical development progress of its next generation VEGF antagonist
PRS-050 program on track to commence clinical trials as planned

Freising-Weihenstephan, Germany (ots)

Pieris AG, the
biopharmaceutical company developing Anticalins as a novel class of 
targeted human protein therapeutics, today reported continued 
progress in development of its lead therapeutic program for the 
clinic. Under its manufacturing agreement with Wacker Biotech GmbH, a
full-service contract manufacturer of biopharmaceuticals, Pieris has 
successfully completed the first cGMP run of its Anticalin candidate 
PRS-050, a potent VEGF antagonist with broad therapeutic 
applicability.
Having established production process parameters for PRS-050 
earlier in 2009, Pieris has now met all regulatory CMC requirements 
to file an IND application by the end of January 2010. With 
toxicology studies running concurrently, PRS-050 is scheduled to 
commence first in man studies in the first half of 2010. Progress in 
the PRS-050 program demonstrates that Anticalin discovery programs 
can be successfully advanced from lead candidate to GMP production in
around twelve months.
Commenting on these developments at Pieris, Claus Schalper, 
interim-CEO, said: "Sustained progress in development of PRS-050 
underscores our commitment to advancing our lead Anticalin program 
into the clinic as quickly and efficiently as possible. This is in 
line with Pieris' strategy to bring Anticalins into the clinics while
partnering selected project at an earlier development stage."
Pieris AG
Pieris is a biopharmaceutical company engaged in the discovery and
development of Anticalins, a novel class of targeted human proteins 
designed to diagnose and treat serious human disorders. Exploiting 
extensive know-how in protein engineering as part of a broad 
intellectual property portfolio, the company applies a balanced risk 
business model to the development of Anticalin product candidates.
About Anticalin Technology
Anticalins are engineered binding proteins derived from the 
scaffold of natural human lipocalins. Anticalins are selected to have
prescribed binding properties with selectivity and affinity 
fundamentally similar to that of monoclonal antibodies. Being human 
in origin, Anticalins are predicted to have minimal immunogenicity in
man. Furthermore, compared to conventional antibodies Anticalins 
benefit from their small size (20 kDa), robust physicochemical 
properties and simple composition that together allow highly soluble 
and stable products to be manufactured from bacteria. Anticalins are 
amenable to further engineering to balance their favorable tissue 
penetration with adjustable serum half-life. Moreover, Anticalins 
have been developed as Duocalins, whose dual targeting format allows 
multiple targets to be bound and modulated through a single molecule.
Pieris exclusively owns the Anticalin patent estate, which offers 
complete freedom to operate outside the patent boundaries defined by 
conventional antibody products. Key patents have already been granted
in the US, Asia and Europe.
About PRS-050
PRS-050 Anticalin has been designed to specifically bind and block
the signaling activity of vascular endothelial growth factor (VEGF) 
in cancer. Optimised for extended serum half-life, PRS-050 exhibits 
comparable binding and functional in vitro activity to approved VEGF 
antagonists. Potent inhibition of VEGF-induced enhanced vascular 
permeability and angiogenesis, as well as anti-tumour activity, have 
already been demonstrated for PRS-050 in various well-validated in 
vivo preclinical studies.
As a next generation VEGF antagonist, PRS-050 exploits several 
favourable characteristics of Anticalins, including compact protein 
structure, high intrinsic stability, broad formulation flexibility 
and small molecular size with the potential to penetrate 
neovascularized tumour tissue more effectively. PRS-050 is being 
developed for a Phase I study in patients with advanced malignancies.
Further information on Pieris AG is available at 
www.pieris-ag.com.
For further information, please contact:
Pieris AG 
Claus Schalper, 
Interim-CEO 
Phone +49 (0) 8161 1411 400

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