Pieris Reports Development Progress for Anticalin(R) PRS-050, a Next Generation VEGF Antagonist

Wednesday, February 4, 2009 General News
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FREISING-WEIHENSTEPHAN, Germany, February 3 Pieris AG, abiopharmaceutical company developing Anticalins(R), a novel class of targetedhuman protein therapeutics, reports today that it has made significantprogress in the development of its Anticalin(R) candidate PRS-050, a potentVEGF antagonist with broad therapeutic applicability.

Having successfully demonstrated the mode of action of PRS-050 in vitroand in vivo, Pieris has now validated the efficacy of the Anticalin(R)product candidate in several preclinical models. Amongst those tested,DCE-MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging) has beenestablished and validated to monitor immediate treatment effects in theupcoming Phase I clinical trial. Production process parameters for GMPmanufacture of PRS-050 have also been clearly defined. Initial toxicologyresults have shown that PRS-050 is very well tolerated.

Progress in the PRS-050 program demonstrates that Pieris has fulfilledcritical speed and capacity goals in producing Anticalins(R) as clinicalproduct candidates. Discovery programs can be advanced from lead candidate toGMP production in less than twelve months. Furthermore, several grams perliter production of Anticalins(R) in Wacker Biotech's proprietary bacterialsecretion system ESETEC(R) supports broad therapeutic application of theAnticalin(R) technology.

In light of the progress in its lead proprietary program, the Companyalso announced the expansion of its Management Team with the appointment ofDr Kristian Jensen as Chief Operating Officer. Dr Angelika Stern willhenceforth be fully dedicated to management of the PRS-050 program in her newfunction as Head of Project Management Angiogenesis.

Kristian Jensen joins Pieris from Merck Serono, where he spent almostthree years establishing and managing its phage display antibody facility inGeneva, Switzerland. Prior to Merck Serono, he obtained his researchmanagement experience during four years as Group Leader in discovery atXerion Pharmaceuticals AG, and more recently while responsible for keyexternal collaborations at Pieris. Dr Jensen has a background in chemistryand holds a PhD in molecular biology from the University of Aarhus, Denmark.

Commenting on these developments at Pieris, Evert Kueppers, ChiefExecutive Officer, stated: "I am delighted to welcome Kristian to head upresearch activities at Pieris. With his extensive experience in the discoveryand development of biologics, together with his knowledge of the demands ofproduct-focused biopharmaceutical companies, he will provide invaluableresearch direction to both our partnered and proprietary Anticalin(R)programs."

Kristian Jensen commented further: "Pieris has made remarkable progressover the past three years and together with its current financial strength,offers an exciting opportunity to further develop the Anticalin(R) portfolio,thereby combining conventional antibody advantages with key features of smallmolecule drugs."

About Pieris AG

Pieris is a biopharmaceutical company engaged in the discovery anddevelopment of Anticalins(R), a novel class of targeted human proteinsdesigned to diagnose and treat serious human disorders.

About Anticalin(R) Technology

Anticalins(R) are engineered binding proteins derived from the scaffoldof natural human lipocalins. Anticalins are selected to have prescribedbinding properties with selectivity and affinity fundamentally similar tothat of monoclonal antibodies. Being human in origin, Anticalins arepredicted to have minimal immunogenicity in man. Furthermore, compared toconventional antibodies Anticalins benefit from their small size (20 kDa),robust physicochemical properties and simple composition that together allowhighly soluble and stable products to be manufactured from bacteria.Anticalins are amenable to further engineering to balance their favorabletissue penetration with adjustable serum half-life. Moreover, Anticalins havebeen developed as Duocalins(R), whose dual targeting format allows multipletargets to be bound and modulated through a single molecule. Pierisexclusively owns the Anticalin patent estate, which offers complete freedomto operate outside the patent boundaries defined by conventional antibodyproducts. Key patents have already been granted in the US, Asia and Europe.

About PRS-050

PRS-050 Anticalin(R) has been designed to specifically bind and block thesignaling activity of vascular endothelial growth factor (VEGF) in cancer.Optimised for extended serum half-life, PRS-050 exhibits comparable bindingand functional in vitro activity to approved VEGF antagonists. Potentinhibition of VEGF-induced enhanced vascular permeability and angiogenesis,as well as anti-tumour activity, have already been demonstrated for PRS-050in various well-validated in vivo preclinical studies.

As a next generation VEGF antagonist, PRS-050 exploits several favourablecharacteristics of Anticalins(R), including compact protein structure, highintrinsic stability, broad formulation flexibility and small molecular sizewith the potential to penetrate neovascularized tumour tissue moreeffectively. PRS-050 is currently being prepared for a Phase I study inpatients with advanced malignancies.Further information on Pieris AG is available at http://www.pieris-ag.com. Anticalin(R) and Duocalin(R) are registered trademarks of Pieris AG. ESETEC(R) is a registered trademark of Wacker Chemie AG. For further information, please contact: Pieris AG Phone +49(0)8161-1411-400 Evert Kueppers, Chief Executive Officer


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