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.

Originaltext: Pieris AG
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For further information, please contact:
Pieris AG
Claus Schalper,
Interim-CEO
Phone +49 (0) 8161 1411 400