On July 20, 2020 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 its phase 1 studies of PRS-343 have been placed on partial clinical hold by the U.S. Food and Drug Administration (FDA) while Pieris conducts an additional in-use and compatibility study requested by the Agency (Press release, Pieris Pharmaceuticals, JUL 20, 2020, View Source [SID1234562128]). Currently-enrolled patients may continue to receive treatment, although no new patients can be enrolled until resolution of this partial hold.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The partial hold follows discussions with FDA regarding the Company’s in-use study supporting the technical setup for clinical administration of PRS-343. Specifically, FDA has requested that Pieris conduct an additional in-use and compatibility study of PRS-343 with various infusion materials under specific conditions to confirm suitability of PRS-343 for administration in clinical settings. In its telephonic communication, the Agency did not cite any adverse events in connection with its request. In-use and compatibility studies are laboratory-based studies typically conducted to evaluate the impact of product handling on a drug candidate’s behavior, including effects of dilution media, hold times, and adsorption to materials such as tubing and infusion bags before administration to patients. As part of the development of PRS-343, Pieris conducted in-use and compatibility studies prior to phase 1 and thereafter, the results of which were shared with the Agency.
Separately, the Company has received a written response from the Agency to its Type C meeting request related to the planned phase 2 proof of concept study of PRS-343 in combination with ramucirumab and paclitaxel. Based on this response, Pieris continues to believe it can initiate this clinical study later this year, pending successful completion of the requested in-use and compatibility study.
"We share FDA’s commitment to product quality and will continue to engage with the Agency to initiate and complete the requested in-use and compatibility study with the highest priority," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "Pending satisfactory completion of this laboratory study, we remain committed to continuing the development of PRS-343, including the initiation of a phase 2 study in second-line gastric cancer in combination with the standard of care this year, as previously communicated. We also remain on track to present comprehensive data from both the monotherapy and atezolizumab combination phase 1 studies at a medical conference later this year."
About PRS-343:
PRS-343 is a 4-1BB/HER2 fusion protein comprising a 4-1BB-targeting Anticalin protein and a HER2-targeting antibody. The drug candidate is currently in development for the treatment of HER2-positive solid tumors. Ongoing phase 1 studies of PRS-343 include a monotherapy study and a combination study with atezolizumab. Based on encouraging initial results from both studies, which demonstrated clinical benefit and biomarker data indicative of a 4-1BB-driven mechanism of action, the Company is actively working towards initiating a phase 2 study of PRS-343 in combination with ramucirumab and paclitaxel for the treatment of HER2-positive gastric cancer in a second line setting later this year.