Theriva Biologics received AEMPS authorization to initiate the VIRAGE2 Phase 2a trial testing more frequent VCN-01 dosing in first-line metastatic pancreatic cancer.
Key Highlights:
- AEMPS authorized the VIRAGE2 Phase 2a single-arm, open-label trial (EUCT: 2026-525566-21-00) to proceed in Spain.
- VIRAGE2 will enroll 6 evaluable newly diagnosed metastatic PDAC patients to test at least three VCN-01 doses two months apart with gemcitabine/nab-paclitaxel.
- Primary endpoints: safety (adverse events) and VCN-01 viral genome levels to assess tolerability and pharmacodynamics of more frequent dosing.
- Study builds on 112-patient VIRAGE Phase 2b data showing improved survival with two VCN-01 doses and will inform dosing for a potential Phase 3 trial.
Original SEC Filing:
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