Theriva™ Biologics Announces Positive Scientific Advice from the European Medicines Agency (EMA) on the Design of a Phase 3 Trial of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Core Insights - Theriva Biologics has received scientific advice from the EMA regarding the Phase 3 clinical trial design for VCN-01 in combination with gemcitabine/nab-paclitaxel for treating metastatic PDAC [1][3] - The company plans to hold an End-of-Phase 2 meeting with the FDA in H1 2026 to finalize the design of a pivotal multinational Phase 3 clinical trial [1][4] - Theriva's cash runway extends until Q1 2027, allowing for the completion of regulatory activities and protocol development for VCN-01 trials [1][4] Clinical Trial Developments - The Phase 2b clinical trial (VIRAGE) showed that patients receiving VCN-01 with standard chemotherapy had improved overall survival and progression-free survival compared to those receiving chemotherapy alone [2] - The CHMP supports a single, high-quality, double-blinded, randomized, placebo-controlled Phase 3 trial if it demonstrates a compelling benefit-risk ratio [3] - The proposed trial design includes adaptive elements, primary endpoint of overall survival, and secondary endpoints such as progression-free survival and duration of response [3] Regulatory and Financial Outlook - The company is encouraged by the EMA's agreement on the dosing regimen for VCN-01, which may enhance survival outcomes [4] - Theriva had $15.5 million in cash and equivalents as of November 10, 2025, providing sufficient funds to support ongoing regulatory interactions and potential partnerships [4] - The company aims to seek regulatory advice for a potential Phase 2/3 trial of VCN-01 in retinoblastoma in 2026 [4]