Theriva doses first patients in VIRAGE2 trial of VCN-01 in pancreatic cancer

Theriva Biologics said the first patients have been dosed in the VIRAGE2 Phase 2a clinical trial, a single-arm, single-center, open-label proof-of-concept study testing increased-frequency dosing of VCN-01 (zabilugene almadenorepvec) combined with gemcitabine and nab-paclitaxel in newly diagnosed metastatic pancreatic cancer patients (EUCT: 2026-525566-21-00; NCT07701486).¹

The trial design reflects input from regulators. Feedback from both the European Medicines Agency and the U.S. Food and Drug Administration informed the design, following improved survival seen in the earlier VIRAGE Phase 2b trial where metastatic PDAC patients received two doses of VCN-01 alongside standard chemotherapy.¹ In VIRAGE2, at least three doses of VCN-01 will be given roughly two months apart with standard-of-care chemotherapy, in a study expected to enroll six evaluable patients.¹ Enrollment is expected to complete in the second half of 2026, with initial pharmacodynamic and safety/tolerability data anticipated by the third quarter of 2027.¹

On the retinoblastoma program, Theriva said it completed design of a proposed Phase 2/3 trial combining intravitreal VCN-01 with intravitreal topotecan in children with vitreous-seed retinoblastoma resistant to current intravitreal chemotherapy¹, and plans to discuss the protocol with the FDA in the third quarter of 2026.¹ The company noted VCN-01 holds Orphan Drug Designation from the FDA and EMA and Rare Pediatric Disease Designation from the FDA for retinoblastoma, and a BLA approval by September 30, 2029 could make the company eligible for a Priority Review Voucher.¹

Separately, results from a Phase 1 trial combining intravenous VCN-01 with durvalumab in refractory head and neck squamous cell carcinoma were published in Clinical Cancer Research, with prolonged overall survival observed in heavily pretreated patients given VCN-01 ahead of durvalumab.¹

Financially, cash and cash equivalents totaled $11.3 million as of June 30, 2026, down $1.7 million from December 31, 2025,¹ with the company stating runway into the first quarter of 2027.