FDA Lifts Partial Clinical Hold on PRS-343 Phase 1 Studies

BOSTON, MA, USA I January 19, 2021 I Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, today announced that the U.S. Food and Drug Administration (FDA) has lifted the previously announced partial clinical hold on the phase 1 studies of PRS-343. As previously guided, the Company intends to move into a proof-of-concept study of PRS-343 in gastroesophageal cancer.

"It has been rewarding to see the impact of PRS-343 on the lives of patients in these studies. Data continue to be encouraging, and the clinical benefit linked to single-agent activity that we have seen attests to the potential of this therapy and, more broadly, our localized 4-1BB agonism approach," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "We are excited to advance this program into the proof-of-concept phase and look forward to sharing more details about the study later this quarter."

About Pieris Pharmaceuticals:

Pieris is a clinical-stage biotechnology company that discovers and develops Anticalin protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes inhalable Anticalin proteins to treat respiratory diseases and immuno-oncology multi-specifics tailored for the tumor microenvironment. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies, including AstraZeneca, Seagen, and Servier. Anticalin® is a registered trademark of Pieris. For more information, visit www.pieris.com.

SOURCE: Pieris Pharmaceuticals

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