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Pieris Initiates Phase I Clinical Trial for Lead Anticalin Compound

Tuesday, June 15, 2010 General News J E 4
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FREISING-WEIHENSTEPHAN, Germany, June 15, 2010 Pieris AGannounced today the initiation of a Phase I clinical trial in cancer patientsfor its lead program, PRS-050, an anti-VEGF Anticalin. The trial is anopen-label, dose-escalating evaluation of the compound's safety andtolerability in patients with solid tumors. Conducted at three sites inGermany, the trial is underway and patients from the first cohort have beendosed.

"Meeting our goal of initiating this trial in the first half of 2010demonstrates Pieris' commitment to establishing the safety and thetherapeutic relevance of the Anticalin drug class," stated Stephen Yoder, CEOof Pieris. "Further, the high potency observed in preclinical studies,together with the small size and the lack of an antibody Fc domain, showpromise of an attractive combined efficacy and safety profile for PRS-050."

The trial is designed to test PRS-050 in approximately 40 patients, whowill receive the compound and then be monitored for safety and tolerability.The patients recruited for the trial are cancer patients with advanced,recurrent or metastatic solid tumors, refractory to standard therapy.

PRS-050 is an anti-VEGF (Vascular Endothelial Growth Factor) Anticalindiscovered and developed internally at the company from Pieris' proprietaryAnticalin libraries. PRS-050's mechanism of action is based on its ability tobind the VEGF ligand, thereby inhibiting tumor growth. VEGF's role in cancerangiogenesis, the mechanism by which cancer tumors increase blood vesseldevelopment to deliver key nutrients and oxygen is well established, bothscientifically and clinically.

About Pieris

Pieris AG is an independent biotechnology company advancing itsproprietary Anticalin(R) technology to create safer, more efficacious andmore convenient protein therapeutics. Exclusive to Pieris, Anticalin-baseddrugs promise to address high-unmet medical needs and expand the therapeuticpotential of current targeted approaches. Pieris' pipeline ranges from itslead clinical program (anti-VEGF, oncology), to multiple Anticalins inpreclinical development. Pieris will commercialize Anticalin therapeuticsthrough strategic partnerships, involving both its proprietary pipeline andits de novo drug discovery capabilities. Its most recent partnership is withAllergan, Inc. (NYSE: AGN), focusing on novel treatments for eye diseases.Privately held, Pieris has been funded by premier biotechnology-focusedventure capital, including lead investors OrbiMed Advisors and Global LifeScience Ventures.

For more information, please contact: Pieris AG, Stephen Yoder, CEO,+49(0)8161-1411-400, info@pieris-ag.com

SOURCE Pieris AG
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