Theriva Biologics, Inc. (NYSE: TOVX) shares are significantly gaining traction on the charts during pre-market session today, up 62.5% to $2.21 as of the last check. The company’s Phase 2b VIRAGE clinical study, which evaluated its lead candidate VCN-01 in conjunction with conventional chemotherapy for the treatment of metastatic pancreatic ductal adenocarcinoma (PDAC), revealed positive topline data, which triggered the stock jump.
Positive Clinical Results
Ninety-six newly diagnosed metastatic PDAC patients on first-line treatment were evaluated in the VIRAGE study. Two groups were compared in the study: one that received VCN-01 first, followed by gemcitabine/nab-paclitaxel standard-of-care (SoC), and the other that received SoC exclusively.
The median overall survival (OS) for patients in the VCN-01 group was 10.8 months, while the median OS for patients in the SoC-only group was 8.6 months. A significant increase in progression-free survival (PFS) and a median duration of response (DoR) that doubled from 5.4 to 11.2 months with VCN-01 corroborated this survival improvement.
Regulatory Momentum and Therapeutic Potential
The U.S. Food and Drug Administration has designated the tumor-selective, stroma-degrading oncolytic adenovirus VCN-01 as an Orphan Drug and Fast Track. The reduced hazard ratios in this cohort further indicate potential for prolonged survival, positioning VCN-01 as a promising adjunct to existing PDAC treatments.
Enhanced outcomes were particularly evident in patients who received two doses of VCN-01 along with four or more chemotherapy cycles, suggesting a cumulative therapeutic benefit.
Safety Profile and Next Steps
Theriva confirmed that VCN-01’s safety profile remained consistent with previous trials. Reported adverse events (AEs) were mostly mild, transient, and decreased in frequency and severity after the second dose. The Independent Data Monitoring Committee found the AE profile appropriate for this patient population and treatment regimen.
Theriva anticipates leveraging this data, along with guidance from U.S. and European regulatory bodies, to initiate a Phase 3 confirmatory trial. A live virtual event is being hosted by Theriva (TOVX) today to discuss the implications and next stages for VCN-01 development.
