Theriva Biologics announces 1st patient dosed in VIRAGE Phase 2b trial

Theriva Biologics announced the first patient has been dosed in VIRAGE, the Phase 2b randomized, open-label, placebo-controlled, multicenter clinical trial of systemically administered VCN-01 in combination with standard-of-care SoC chemotherapy or gemcitabine/nab-paclitaxel as a first line therapy for patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma, PDAC."The dosing of the first patient in our Phase 2b PDAC trial represents an important step in our pursuit to address unmet needs for patients with difficult-to-treat cancers," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "The incidence of PDAC continues to rise and while it continues to have one of the lowest survival rates among all cancer types, efforts to improve upon the standard of care treatment have largely stalled. In contrast, we are encouraged by the growing clinical data that underscore VCN-01’s differentiated mechanism of action, as well as the biological activity and synergistic clinical benefit observed in combination with SoC chemotherapy for patients with PDAC and other solid tumors. With regulatory clearance from the FDA and AEMPS, we look forward to the continued progress of this program and more broadly, the advancement of our novel OV platform."