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Pieris Pharmaceuticals Receives Orphan Drug Designation for Cinrebafusp Alfa for the Treatment of Gastric Cancer
BOSTON, MA / ACCESSWIRE / June 24, 2021 / Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics
About this update from Palvella Therapeutics, Inc.
[{"type":"text","content":"BOSTON, MA / ACCESSWIRE / June 24, 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, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to cinrebafusp alfa (PRS-343), a 4-1BB/HER2 bispecific, for the treatment of HER2-high and HER2-low expressing gastric cancers.\"The granting of orphan drug designation to cinrebafusp alfa underscores the high unmet medical need that persists in the treatment of gastric cancer and reinforces our conviction in the importance of developing this program while setting a high bar for success to help patients with limited therapeutic options,\" said Stephen S. Yoder, President and Chief Executive Officer of Pieris. \"We look forward to beginning the phase 2 trial of cinrebafusp alfa later this summer.\"FDA grants orphan drug designation to promote the development of a drug that targets a condition affecting 200,000 or fewer U.S. patients annually. Orphan drug designation provides qualifying therapies with development and commercial incentives, including FDA assistance in clinical trial design, tax credits for eligible clinical trials, waiver of application fees, and market exclusivity for seven years following FDA approval, in addition to other available regulatory exclusivities.About Cinrebafusp Alfa:Cinrebafusp alfa (PRS-343) is a 4-1BB/HER2 fusion protein comprising a 4-1BB-targeting Anticalin protein and a HER2-targeting antibody. Based on encouraging phase 1 study results, which demonstrated clinical benefit as single agent and biomarker data indicative of a 4-1BB-driven mechanism of action, the Company is actively working towards initiating a phase 2 study of cinrebafusp alfa in combination with ramucirumab and paclitaxel for the treatment of HER2-high expressing gastric cancer and in combination with tucatinib for the treatment of HER2-low expressing gastric cancer.About Pieris Pharmaceuticals:Pieris is a clinical-stage biotechnology company that combines leading protein engineering capabilities and deep understanding into molecular drivers of disease to develop medicines that drive local biology to produce superior clinical outcomes for patients. Our pipeline incl...