Theriva™ Biologics Announces Publication of the Results from the VIRAGE Phase 2b Clinical Trial of VCN-01 in Metastatic Pancreatic Cancer Published in Nature Medicine

Theriva™ Biologics, a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that detailed analysis of results from the VIRAGE Phase 2b clinical trial of VCN-01 (zabilugene almadenorepvec) in metastatic pancreatic cancer patients were published in Nature Medicine. The article, entitled “Intravenous hyaluronidase-expressing oncolytic adenovirus with chemotherapy in metastatic pancreatic cancer: a randomised phase 2b trial”, can be read here.

“We are proud to see the peer-reviewed results from the VIRAGE trial published in Nature Medicine and made available to the entire scientific community,” said Manel Cascalló, PhD, General Director of Theriva Biologics S.L. and co-author of the article. “As elaborated in the publication, improved overall survival, progression free survival, and duration of response were observed in metastatic pancreatic cancer patients treated with VCN-01 combined with standard-of-care (SoC) gemcitabine/nab-paclitaxel chemotherapy compared to patients receiving SoC chemotherapy alone. Moreover, the Kaplan-Meier survival analysis and the timing of responses in VCN-01 treated patients suggest an immune mediated mechanism of action for VCN-01 in addition to its stroma degrading effects. We are excited about the potential for VCN-01 in different cancer therapy combinations, and we are extremely grateful to the patients who participated in VIRAGE, their families, our clinical investigators and their teams, and our co-authors for their commitment, dedication and diligence.”

As previously reported, greater improvements in patient survival during the VIRAGE study were observed in metastatic pancreatic cancer patients receiving 2 doses of VCN-01 administered 3 months apart, Following End-of-Phase 2 feedback from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), Theriva has recently initiated VIRAGE2; a small Phase 2a study designed to evaluate the feasibility of more frequent, repeated dosing of VCN-01 in combination with SoC chemotherapy. The first patient in VIRAGE2 was treated in August 2026, and the study is expected to complete enrollment during the second half of 2026. Initial pharmacodynamic and safety/tolerability data are anticipated by Q3 2027. Results from VIRAGE2 will inform the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial. For more details see About VIRAGE2 below.

In parallel with VIRAGE2, Theriva is engaging with the FDA to finalize the design of a potential Phase 2/3 study evaluating VCN-01 in children with retinoblastoma with vitreous seeds that are refractory/resistant to the use of current intravitreal chemotherapy. VCN-01 has received Rare Pediatric Disease designation for the treatment of retinoblastoma and may be eligible to receive a Priority Review Voucher if VCN-01 is approved in this indication by September 30, 2029.