Theriva gets Spanish authorization for VIRAGE2 trial of VCN-01 in pancreatic cancer

Theriva Biologics announced on July 7, 2026 that Spain's AEMPS authorized the company to begin the VIRAGE2 clinical trial, a study titled "A Phase IIa, single-arm, single-center, open-label, proof-of-concept trial evaluating increased frequency dosing of zabilugene almadenorepvec (VCN-01) in combination with gemcitabine/nab-paclitaxel in patients with newly-diagnosed metastatic pancreatic cancer"¹ (EUCT: 2026-525566-21-00).

The new trial follows earlier work in the 112-patient VIRAGE Phase 2b clinical trial, which tested VCN-01 in treatment naive metastatic pancreatic ductal adenocarcinoma patients on gemcitabine/nab-paclitaxel standard-of-care chemotherapy¹. In that study, patients given two doses of VCN-01 three months apart showed significantly better overall survival, progression free survival, and duration of response than those getting a single dose or chemotherapy alone¹. Theriva said both the EMA and FDA acknowledged the survival benefit in the two-dose group and suggested that more frequent repeated dosing might further improve outcomes¹.

VIRAGE2 will test that idea directly. The trial will enroll 6 evaluable patients with newly diagnosed metastatic PDAC at a single site in Spain, with patients receiving at least three treatment cycles of VCN-01 alongside gemcitabine/nab-paclitaxel chemotherapy, followed by additional standard-of-care cycles until progression.¹ The main goal is to determine whether giving at least three doses of VCN-01 two months apart is well tolerated and does not interfere with the drug's activity in the body.¹ Primary endpoints are adverse events and levels of VCN-01 viral genomes in blood,¹ while the study is not statistically powered to assess clinical efficacy but is meant to inform later trials¹. Results are intended to guide the dosing regimen for a possible future Phase 3 trial.¹