Theriva doses first patient in VIRAGE2 trial testing repeat VCN-01 dosing in pancreatic cancer

Theriva Biologics announced on August 6, 2026 that it had dosed the first patient in the VIRAGE2 Phase 2a trial, a small proof-of-concept study testing more frequent repeated dosing of VCN-01 (zabilugene almadenorepvec) in first-line metastatic pancreatic ductal adenocarcinoma patients receiving standard-of-care gemcitabine/nab-paclitaxel chemotherapy.¹

The company said enrollment in the trial is expected to finish in the second half of 2026, with initial pharmacodynamic and safety and tolerability data expected around the third quarter of 2027.¹ Theriva said the trial's results will help shape the VCN-01 dosing regimen that could be used in a future pivotal Phase 3 study.¹

The design builds on earlier findings: in the VIRAGE Phase 2b trial, patients who received two doses of VCN-01 alongside gemcitabine/nab-paclitaxel showed improved overall survival, progression-free survival, and duration of response compared with chemotherapy alone.¹ Theriva noted that both the EMA and FDA had acknowledged this survival benefit and suggested that giving VCN-01 more often could further improve outcomes.¹

VIRAGE2 is a single-site trial in Spain. It is a single-arm, open-label study enrolling 6 evaluable patients with newly diagnosed metastatic PDAC, who are meant to receive at least three "macrocycles" of VCN-01 combined with SoC chemotherapy, followed by chemotherapy alone until disease progression.¹ The trial's main goal is to determine whether at least three VCN-01 doses, spaced about two months apart, are tolerated without harming the drug's pharmacodynamic activity, with adverse events and viral genome levels in blood as primary endpoints.¹ The study is registered under EUCT 2026-525566-21-00 and NCT07701486, and is not statistically powered to assess clinical efficacy.¹