Pieris Pharma Inc. (NASDAQ: PIRS) stock surged by 23.45% at last close whereas the PIRS stock price soared by 15.79% in the pre-market trading session. Pieris is a clinical-stage biotechnology firm that combines top protein engineering skills with a comprehensive understanding of disease molecular drivers to create medications that drive local biology and improve patient outcomes.
What is happening?
Pieris Pharmaceuticals confirmed recently that it has received approval from the U.S. Food and Drug Administration. The FDA has designated cinrebafusp alfa (PRS-343), a 4-1BB/HER2 bispecific, as an orphan drug for the cure of both HER2-high and HER2-low expressing gastric cancers.
Cinrebafusp alfa (PRS-343) is a 4-1BB/HER2 fusion protein made up of an Anticalin protein that targets 4-1BB and a HER2-targeting antibody. PIRS is working diligently to initiate a phase 2 research of cinrebafusp alfa in conjunction with ramucirumab and paclitaxel for the therapy of HER2-high tumors, depending on motivating phase 1 study results that exhibited medical efficacy as a single agent and biomarker data indicative of a 4-1BB-driven mechanism of action. However, it expresses gastric cancer and is used in conjunction with tucatinib to treat HER2-low expressing gastric cancer.
The FDA designates a medication as orphan to encourage the development of a treatment for an illness that affects fewer than 200,000 people in the United States each year. Orphan drug classification provides research and marketing advantages to qualified medicines, such as FDA help in clinical trial design, tax credits for eligible clinical studies, and application fee waivers. In addition, market exclusivity for seven years following FDA clearance, as well as any other regulatory exclusivities that may be available.
Stephen S. Yoder, President and Chief Executive Officer of Pieris stated,
The classification of cinrebafusp alfa as an orphan drug highlights the significant unfulfilled medical requirements for the treatment of gastric cancer, and it strengthens their belief in the importance of developing this plan while creating a high bar for success in order to assist patients with limited therapeutic options. They’re excited to start the cinrebafusp alfa phase 2 study later this summer.