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Pieris AG

Pieris reports development progress for Anticalin® PRS-050, a next generation VEGF antagonist
Expansion of management team announced to support program success

Freising-Weihenstephan, Germany (ots)

Pieris AG, a
biopharmaceutical company developing Anticalins®, a novel class of 
targeted human protein therapeutics, reports today that it has made 
significant progress in the development of its Anticalin® candidate 
PRS-050, a potent VEGF antagonist with broad therapeutic 
applicability.
Having successfully demonstrated the mode of action of PRS-050 in
vitro and in vivo, Pieris has now validated the efficacy of the
Anticalin® product candidate in several preclinical models. Amongst
those tested, DCE-MRI (Dynamic Contrast-Enhanced Magnetic Resonance
Imaging) has been established and validated to monitor immediate
treatment effects in the upcoming Phase I clinical trial. Production
process parameters for GMP manufacture of PRS-050 have also been
clearly defined. Initial toxicology results have shown that PRS-050
is very well tolerated.
Progress in the PRS-050 program demonstrates that Pieris has
fulfilled critical speed and capacity goals in producing Anticalins®
as clinical product candidates. Discovery programs can be advanced
from lead candidate to GMP production in less than twelve months.
Furthermore, several grams per liter production of Anticalins® in
Wacker Biotech's proprietary bacterial secretion system ESETEC®
supports broad therapeutic application of the Anticalin® technology.
In light of the progress in its lead proprietary program, the
Company also announced the expansion of its Management Team with the
appointment of Dr Kristian Jensen as Chief Operating Officer. Dr
Angelika Stern will henceforth be fully dedicated to management of
the PRS-050 program in her new function as Head of Project Management
Angiogenesis.
Kristian Jensen joins Pieris from Merck Serono, where he spent
almost three years establishing and managing its phage display
antibody facility in Geneva, Switzerland. Prior to Merck Serono, he
obtained his research management experience during four years as
Group Leader in discovery at Xerion Pharmaceuticals AG, and more
recently while responsible for key external collaborations at Pieris.
Dr Jensen has a background in chemistry and holds a PhD in molecular
biology from the University of Aarhus, Denmark.
Commenting on these developments at Pieris, Evert Kueppers, Chief
Executive Officer, stated: "I am delighted to welcome Kristian to
head up research activities at Pieris. With his extensive experience
in the discovery and development of biologics, together with his
knowledge of the demands of product-focused biopharmaceutical
companies, he will provide invaluable research direction to both our
partnered and proprietary Anticalin® programs."
Kristian Jensen commented further: "Pieris has made remarkable
progress over the past three years and together with its current
financial strength, offers an exciting opportunity to further develop
the Anticalin® portfolio, thereby combining conventional antibody
advantages with key features of small molecule drugs".
About 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.
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 currently
being prepared for a Phase I study in patients with advanced
malignancies.
Further information on Pieris AG is available at
www.pieris-ag.com.
Anticalin® and Duocalin® are registered trademarks of Pieris
AG. ESETEC® is a registered trademark of Wacker Chemie AG.

Contact:

Pieris AG
Phone: +49/(0)8161/1411'400
Evert Kueppers, Chief Executive Officer

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