FREISING-WEIHENSTEPHAN, Germany, October 9 Pieris AG, thebiopharmaceutical company developing Anticalins as a novel class of targetedhuman protein therapeutics, today reported continued progress in developmentof its lead therapeutic program for the clinic.
Under its manufacturing agreement with Wacker Biotech GmbH, afull-service contract manufacturer of biopharmaceuticals, Pieris hassuccessfully 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 in2009, Pieris has now met all regulatory CMC requirements to file an INDapplication by the end of January 2010. With toxicology studies runningconcurrently, PRS-050 is scheduled to commence first in man studies in thefirst half of 2010. Progress in the PRS-050 program demonstrates thatAnticalin discovery programs can be successfully advanced from lead candidateto 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 ourcommitment to advancing our lead Anticalin program into the clinic as quicklyand efficiently as possible. This is in line with Pieris' strategy to bringAnticalins into the clinics while partnering selected project at an earlierdevelopment stage."
About Pieris AG
Pieris is a biopharmaceutical company engaged in the discovery anddevelopment of Anticalins, a novel class of targeted human proteins designedto diagnose and treat serious human disorders. Exploiting extensive know-howin protein engineering as part of a broad intellectual property portfolio,the company applies a balanced risk business model to the development ofAnticalin product candidates.
About Anticalin Technology
Anticalins are engineered binding proteins derived from the scaffold ofnatural human lipocalins. Anticalins are selected to have prescribed bindingproperties with selectivity and affinity fundamentally similar to that ofmonoclonal antibodies. Being human in origin, Anticalins are predicted tohave minimal immunogenicity in man. Furthermore, compared to conventionalantibodies Anticalins benefit from their small size (20 kDa), robustphysicochemical properties and simple composition that together allow highlysoluble and stable products to be manufactured from bacteria. Anticalins areamenable to further engineering to balance their favorable tissue penetrationwith adjustable serum half-life. Moreover, Anticalins have been developed asDuocalins, whose dual targeting format allows multiple targets to be boundand modulated through a single molecule.
Pieris exclusively owns the Anticalin patent estate, which offerscomplete freedom to operate outside the patent boundaries defined byconventional antibody products. Key patents have already been granted in theUS, Asia and Europe.
PRS-050 Anticalin 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, including compact protein structure, highintrinsic stability, broad formulation flexibility and small molecular sizewith the potential to penetrate neovascularized tumour tissue moreeffectively. PRS-050 is being developed for a Phase I study in patients withadvanced malignancies.Further information on Pieris AG is available at http://www.pieris-ag.com. For further information, please contact: Pieris AG Claus Schalper, Interim-CEO Phone: +49(0)8161-1411-400
SOURCE Pieris AG