RE:FDA's Head of CBER wants faster approvals with SE/biomarkersONCYs GOBLET-1 metastatic Pancreatic Cancer (mPC) P2 study reported on T cell receptor sequencing (TCR-seq) data that showed an expansion of new and pre-existing T-cell clones.
TCR clonality is an emerging prognostic biomarker that improves T cell infiltrate information and should lead to ONCY seeking an Accelerated Approval for pelareorep in mPC and mBC.
https://pubmed.ncbi.nlm.nih.gov/34503204/
https://stockhouse.com/companies/bullboard/oncy/oncolytics-biotech-ord-shs?postid=35685575