Theriva Biologics Inc.

Theriva Biologics has dosed the first patient with its oncolytic adenovirus VCN-01 in the Phase 2a VIRAGE2 trial for first-line metastatic pancreatic ductal adenocarcinoma. The single-arm, open-label study will enroll six patients in Spain to evaluate repeated dosing of VCN-01 alongside standard-of-care gemcitabine/nab-paclitaxel chemotherapy. The trial builds on Phase 2b VIRAGE results that showed improved overall survival, progression-free survival, and duration of response with two doses of VCN-01 plus chemotherapy versus chemotherapy alone. Theriva expects to complete enrollment in the second half of 2026 and report initial pharmacodynamic, safety, and tolerability data by the third quarter of 2027.

Theriva Biologics has received authorization from the Spanish Agency of Medicines and Medical Devices to initiate its VIRAGE2 Phase 2a clinical trial. The study will evaluate more frequent dosing of VCN-01 in combination with gemcitabine and nab-paclitaxel for first-line patients with metastatic pancreatic ductal adenocarcinoma. The trial builds on results from the earlier 112-patient VIRAGE Phase 2b study, where patients receiving two doses of VCN-01 three months apart showed significantly improved overall survival, progression-free survival, and duration of response compared to those treated with a single dose or standard chemotherapy alone. Both the European Medicines Agency and the U.S. Food and Drug Administration recognized these outcomes and suggested that more frequent dosing could further enhance clinical benefit. VIRAGE2 is designed to test the feasibility of administering at least three doses of VCN-01 two months apart alongside standard chemotherapy, with results informing the dosing regimen for a potential pivotal Phase 3 trial.