ProteinQure receives regulatory clearance to initiate Phase I Trial for PQ203 in the U.S. and Canada; Granted FDA Fast Track Designation

ProteinQure, a leader in computational protein drug discovery, recently announced it has received regulatory clearance from both the U.S. Food and Drug Administration (FDA) and Health Canada to initiate a Phase I clinical trial evaluating the safety, pharmacokinetics, pharmacodynamics and anti-cancer activity of its lead candidate, PQ203. The FDA has also granted PQ203 Fast Track designation for patients with triple negative breast cancer, recognizing the therapy’s potential to address a serious unmet medical need.

PQ203 is a first-in-class therapeutic developed using ProteinQure’s proprietary platform that integrates physics-based modeling with generative machine learning. The company believes PQ203 could unlock new frontiers in oncology by combining high specificity with novel mechanisms of action.

ProteinQure is an OBIO® member, an alumnus of our BDSP™, CAAP®, HealthMINT® and Life Sciences Critical Technologies & Commercialization (LSCTC) Centre of Excellence, and presented at the OBIO® Investment Summit.