Theriva Biologics, Inc. (NYSE American: TOVX) has announced the completion of target patient enrollment in the VIRAGE Phase 2b clinical trial. This trial is evaluating VCN-01, combined with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel), as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The study, conducted across 15 sites in Spain and the USA, enrolled 92 evaluable patients, split evenly between the control and VCN-01 treatment arms, within 21 months.
VCN-01: A Novel Oncolytic Adenovirus
VCN-01 is a systemically-administered, tumor-selective oncolytic adenovirus designed to degrade the tumor stroma, which often acts as a barrier to cancer treatment and suppresses the immune system. The FDA has granted VCN-01 both Orphan Drug and Fast Track designations for PDAC, underscoring the urgent need for effective treatments for this aggressive cancer.
Steven A. Shallcross, CEO of Theriva Biologics, stated, "Rapid progress in the VIRAGE trial is a testament to physician interest in VCN-01 and the significant unmet need for an effective treatment for this deadly disease. We are currently planning regulatory engagements to discuss next steps in VCN-01 clinical development, including the potential for an interim data analysis."
VIRAGE Trial Design
The VIRAGE trial is a two-arm, Phase 2b, open-label, randomized, controlled, multicenter study. It includes patients with histologically confirmed, newly-diagnosed metastatic PDAC. Patients in both arms receive gemcitabine/nab-paclitaxel chemotherapy in 28-day cycles. The treatment arm also receives single doses of intravenous VCN-01, administered seven days before the first and fourth chemotherapy cycles. The primary endpoints are overall survival and VCN-01 safety/tolerability. Secondary endpoints include progression-free survival, objective response rate, and assessments of biodistribution, VCN-01 replication, and immune response.
Pancreatic Cancer Landscape
Pancreatic ductal adenocarcinoma (PDAC) accounts for over 90% of all pancreatic tumors. Due to its typically late diagnosis, only a small percentage of cases are resectable at presentation. The majority of patients are diagnosed at locally advanced or metastatic stages, making effective treatment options crucial. VCN-01's unique mechanism of action aims to address these challenges by selectively targeting and lysing tumor cells, enhancing chemotherapy access, and boosting tumor immunogenicity.
