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

On January 19, 2021 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, reported 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 (Press release, Pieris Pharmaceuticals, JAN 19, 2021, View Source [SID1234574097]). As previously guided, the Company intends to move into a proof-of-concept study of PRS-343 in gastroesophageal cancer.

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"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."