IDMC Endorses Phase 2b VIRAGE Trial of VCN-01 Combo Therapy for Metastatic PDAC

Therapeutic company Theriva Biologics, focusing on developing treatments for cancer and related diseases, has recently announced positive news regarding the VIRAGE clinical trial. The Independent Data Monitoring Committee (IDMC) has given a green light for the trial to proceed without any safety concerns. The VIRAGE trial is a Phase 2b study that combines VCN-01 with standard chemotherapy to treat metastatic pancreatic ductal adenocarcinoma (PDAC). The IDMC has reviewed data from multiple sites in the U.S. and Spain and found the intravenous VCN-01 to be well-tolerated, with no additional toxicities observed in patients receiving a second dose.

Therava Biologics CEO, Steven A. Shallcross, has highlighted the significance of the IDMC's review, noting that VCN-01 is a unique oncolytic adenovirus that selectively targets and breaks down tumor cells and stroma. The VIRAGE study is designed to assess the safety and efficacy of VCN-01 when combined with standard chemotherapy in treating newly diagnosed metastatic PDAC patients. The trial is expected to enroll up to 92 participants across various sites in the U.S. and Spain, with both control and treatment arms receiving standard chemotherapy. The treatment arm will additionally receive VCN-01 prior to the first and fourth chemotherapy cycles.

The primary goals of the VIRAGE trial include evaluating overall survival and the safety and tolerability of VCN-01. Other endpoints will measure progression-free survival, objective response rate, and the biodistribution, replication, and immune response of VCN-01. Since the trial is open-label, progress will be closely monitored, and steps to accelerate the clinical program may be taken if supported by emerging data.

VCN-01's unique mode of action involves selectively infecting and lysing tumor cells, enhancing the access of chemotherapy, and increasing tumor immunogenicity. It has been administered to over 80 patients in various Phase 1 and investigator-sponsored clinical trials for different cancers, including PDAC, head and neck squamous cell carcinoma, ovarian cancer, colorectal cancer, and retinoblastoma.

Theriva Biologics is advancing a new oncolytic adenovirus platform designed for intravenous, intravitreal, and antitumoral delivery to trigger tumor cell death and promote a robust anti-tumor response. The company's lead candidates include VCN-01 and SYN-004 (ribaxamase), designed to degrade IV beta-lactam antibiotics within the gastrointestinal tract to prevent microbiome damage and reduce the incidence of acute graft-versus-host-disease in allogeneic hematopoietic cell transplant recipients. The company is also developing SYN-020, a recombinant oral formulation of intestinal alkaline phosphatase intended to treat both local gastrointestinal and systemic diseases.

The ongoing VIRAGE trial is a crucial step in exploring the potential of VCN-01 to improve clinical outcomes for first-line metastatic PDAC patients treated with standard chemotherapy. With the IDMC's recommendation, Theriva Biologics will continue to advance the study and assess the feasibility of repeated systemic dosing of VCN-01 for improved patient outcomes.