Theriva Biologics Completes Patient Enrollment in VIRAGE Phase 2b Trial for Metastatic Pancreatic Cancer Treatment

Theriva Biologics, Inc., a clinical-stage company focused on developing cancer therapeutics, has announced the successful completion of patient enrollment for its VIRAGE Phase 2b clinical trial. This trial is evaluating VCN-01, the company's leading product, combined with standard chemotherapy (gemcitabine/nab-paclitaxel) as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (PDAC). The target number of 92 evaluable patients has been reached across 15 sites in Spain and the USA within a span of 21 months.

VCN-01 is an innovative oncolytic adenovirus designed to selectively target and destroy tumor cells while breaking down the tumor stroma, which often serves as a barrier to effective cancer treatment. The U.S. Food and Drug Administration (FDA) has granted VCN-01 Orphan Drug Designation and Fast Track Designation for the treatment of PDAC, highlighting its potential impact on this particularly lethal form of cancer.

Steven A. Shallcross, CEO of Theriva Biologics, expressed satisfaction with the rapid progress of the VIRAGE trial, attributing it to the high level of interest from physicians and the pressing need for new treatments for metastatic PDAC. The company is now planning regulatory discussions to determine the next steps in the clinical development of VCN-01, including the possibility of conducting an interim data analysis.

Pancreatic ductal adenocarcinoma, accounting for over 90% of all pancreatic tumors, often goes undiagnosed until it has reached an advanced stage. This type of cancer typically spreads to the liver and peritoneum, and less frequently to the lungs, brain, kidneys, and bones. Due to its late detection, only about 10% of cases are operable at the time of diagnosis. The majority of patients present either with locally advanced unresectable disease or with distant metastases, making therapeutic intervention challenging.

VCN-01 operates by replicating aggressively within tumor cells and degrading the tumor stroma, thus facilitating the penetration of chemotherapies and enhancing immune response against the tumor. Its systemic administration allows it to target both primary tumors and metastases. Apart from the VIRAGE trial, VCN-01 has been tested in over 80 patients in Phase 1 and other investigator-sponsored studies for different cancers, including PDAC, head and neck squamous cell carcinoma, ovarian cancer, colorectal cancer, and retinoblastoma.

The VIRAGE trial is an open-label, randomized, controlled, multicenter study involving patients with newly diagnosed metastatic PDAC. Conducted at 16 sites across the US and Europe, the study aims to enroll 92 evaluable patients, split equally between control and treatment arms. All participants receive standard chemotherapy in 28-day cycles, with the treatment arm additionally receiving intravenous VCN-01 seven days before the first and fourth cycles of chemotherapy. The primary endpoints are overall survival and the safety/tolerability of VCN-01, with secondary endpoints including progression-free survival, objective response rate, and various measures of VCN-01's biological activity.

Theriva Biologics is also developing other therapeutic candidates, including SYN-004 (ribaxamase) and SYN-020, aimed at addressing unmet needs in cancer treatment and other diseases. The company's oncolytic adenovirus platform, which includes VCN-01, is designed to induce tumor cell death, enhance the effectiveness of co-administered therapies, and stimulate a strong and sustained immune response against tumors.