Theriva Biologics gets Spanish regulator approval to start VIRAGE2 Phase 2a trial of VCN-01 in pancreatic cancer

Theriva Biologics, Inc.

AEMPS authorized VIRAGE2, a Phase 2a trial evaluating at least 3 doses of VCN-01 given 2 months apart with gemcitabine/nab-paclitaxel in first-line metastatic PDAC.
VIRAGE2 builds on VIRAGE Phase 2b (112 patients) where 2 doses of VCN-01 3 months apart significantly improved overall survival, PFS, and duration of response vs. 1 dose or SoC alone.
EMA and FDA recognized improved survival with 2 doses and suggested more frequent dosing could improve outcomes.
Results will inform dosing regimen for a potential future pivotal Phase 3 trial.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.