Theriva Biologics announced positive scientific advice from the European Medicines Agency on the design of a Phase 3 trial of VCN-01 in combination with gemcitabine/nab-paclitaxel for metastatic PDAC.
EMA provided overall agreement with the proposed Phase 3 clinical trial, including sample size and dosing details.
The company's cash runway until Q1 2027 will support regulatory activities and partnering efforts for the proposed pivotal trials.
Scientific Advice from EMA
EMA provided agreement on the design of a Phase 3 trial of VCN-01 in metastatic PDAC.
Financial Position
Theriva had $15.5 million in cash and equivalents as of November 10, 2025, supporting activities into Q1 2027.
End-of-Phase 2 Meeting with FDA
Theriva plans to finalize the protocol for a pivotal multinational Phase 3 trial in H1 2026.
Orphan Drug Designation
VCN-01 has been granted Orphan Drug designation for the treatment of metastatic PDAC in Europe and the USA.
Future Clinical Trials
Interactions with regulatory agencies are planned for a potential Phase 2/3 trial for VCN-01 in retinoblastoma.
- The positive scientific advice sets the stage for a pivotal Phase 3 trial of VCN-01 in metastatic PDAC.
- Theriva's financial position provides stability for upcoming regulatory activities and partnerships.
- The agreement on the dosing regimen for VCN-01 highlights the potential for improved patient outcomes in the Phase 3 trial.
With support from EMA and a strong financial position, Theriva Biologics is poised to advance its VCN-01 clinical programs for metastatic PDAC and retinoblastoma, offering innovative treatment options for patients in need.