TOVX · Theriva Biologics, Inc.

Summary

Theriva Biologics, Inc. announced positive outcomes from a Type B End-of-Phase 2 meeting with the FDA on March 23, 2026, regarding the Phase 3 trial design for VCN-01 combined with gemcitabine/nab-paclitaxel for metastatic pancreatic ductal adenocarcinoma. The FDA provided general agreement on the proposed single, randomized, double-blinded trial with repeat dosing, adaptive design, and overall survival as primary endpoint, supporting a potential BLA if successful.

Key takeaways

• FDA general agreement on Phase 3 trial design tracking successful VIRAGE Phase 2 trial announced in 2025
• Phase 3 trial: randomized, double-blinded study of VCN-01 plus gemcitabine/nab-paclitaxel vs. placebo plus SoC for metastatic PDAC
• Repeat dosing of VCN-01 in macrocycles (more than 2 doses), adaptive design, OS primary endpoint, PFS key secondary
• FDA agreement on inclusion/exclusion criteria, dosing, interim analyses, and statistical expectations for sample size re-estimation
• Consistent with prior EMA CHMP advice, proposed Phase 3 (if successful) supports BLA submission
• VIRAGE Phase 2 met primary endpoints with improved OS, PFS, DoR vs. SoC alone; greater benefits with two VCN-01 doses