regulatory
confidence high
sentiment positive
materiality 0.70
Theriva Biologics achieves target enrollment of 92 patients in VIRAGE Phase 2b trial for VCN-01 in pancreatic cancer
Theriva Biologics, Inc.
- Target enrollment of 92 evaluable patients (46 per arm) achieved across 15 sites in Spain and USA within 21 months.
- VCN-01 is a systemically-administered oncolytic adenovirus with FDA Orphan Drug and Fast Track Designations for metastatic PDAC.
- VCN-01 treatment arm: two IV doses (1x10^13 vp/patient) administered ~3 months apart, 7 days prior to gem/nab-paclitaxel cycles.
- Phase 1 data for single VCN-01 dose plus SoC (n=6): 83% overall response rate, median PFS 6.3 months, OS 20.8 months.
- Company plans regulatory engagements to discuss next steps, including potential interim data analysis.