1. EMA supports Phase 3 trial design for VCN-01 in metastatic PDAC. 2. Theriva will meet FDA in H1 2026 to finalize trial protocols. 3. Theriva has cash runway until Q1 2027 for regulatory and trial activities. 4. VCN-01 shows improved survival outcomes in Phase 2b study. 5. Regulatory clarity essential for VCN-01's clinical program partnerships.
FAQ
Why Bullish?
The support from EMA indicates significant regulatory backing, enhancing investor sentiment and potential stock price appreciation similar to past positive trial results for biotech firms. Notably, companies often see stock price rises following favorable regulatory news.
How important is it?
The article conveys substantial developments in VCN-01's clinical trial trajectory, essential for TOVX's future. Positive outcomes could lead to market approval, directly influencing TOVX's stock valuation.
Why Long Term?
The long-term effects hinge on the completion and success of the upcoming Phase 3 trials, which, if successful, can dramatically enhance TOVX's market position and revenue potential.
Theriva™ Biologics Receives Positive Scientific Advice from EMA for Phase 3 Trial of VCN-01 in PDAC
ROCKVILLE, Md., December 29, 2025 (GLOBE NEWSWIRE) – Theriva™ Biologics (NYSE American: TOVX) has announced favorable feedback from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). This advice pertains to the design of a pivotal Phase 3 clinical trial assessing VCN-01 in combination with gemcitabine/nab-paclitaxel for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC).
Details of the Phase 3 Trial Design
The EMA provided overall agreement on critical aspects of the proposed Phase 3 trial. Key elements include:
- Primary endpoint focused on overall survival.
- Secondary endpoints covering progression-free survival, duration of response, and patient-reported outcomes.
- Utilization of an adaptive design to optimize trial timelines and outcomes.
- A proposed sample size that supports robust statistical analysis.
This positive response comes after Theriva's earlier reports from the Phase 2b VIRAGE trial, which showed enhanced survival outcomes for PDAC patients receiving VCN-01 alongside standard chemotherapy. Notably, patients receiving two doses of VCN-01 demonstrated increased overall survival and progression-free survival compared to those receiving gemcitabine/nab-paclitaxel alone.
Next Steps for Theriva Biologics
Looking ahead, Theriva plans to schedule an End-of-Phase 2 meeting with the FDA in the first half of 2026. This meeting will focus on finalizing the design for the multinational Phase 3 trial necessary for market authorization applications (MAA) in PDAC. The company aims to demonstrate a favorable benefit-risk profile for VCN-01 in conjunction with standard chemotherapy protocols.
Financial Position and Future Outlook
As of November 10, 2025, Theriva reported a cash balance of $15.5 million, providing a financial runway into the first quarter of 2027. This capital is earmarked for regulatory engagements, protocol development, and collaboration activities to support the pivotal trials for VCN-01. Additionally, discussions with both the EMA and FDA are planned for 2026 to seek guidance on potential clinical trials of VCN-01 in other applications, including retinoblastoma.
“We are very encouraged by the scientific advice we received from the EMA," stated Steven A. Shallcross, CEO of Theriva Biologics. "The EMA’s agreement on our proposed dosing regimen is a critical milestone as we prepare for our upcoming clinical trials.”
The Significance of VCN-01 in Cancer Treatment
VCN-01 is an innovative oncolytic adenovirus designed to selectively attack tumor cells while disrupting the inhibitory tumor microenvironment. Its unique action allows:
- Selective infection and lysis of cancer cells.
- Enhanced delivery of co-administered chemotherapy agents.
- Increased immunogenicity, allowing for a more effective immune response against the tumor.
This dual action makes VCN-01 a promising candidate for treating not only PDAC but also various other malignancies.
About Theriva™ Biologics
Theriva™ Biologics (NYSE American: TOVX) is a clinical-stage biotechnology firm dedicated to developing advanced therapies targeting cancer and related diseases. The company's proprietary oncolytic adenovirus platform aims to enhance the efficacy of conventional cancer treatments by improving access to tumor sites and promoting synergistic effects through immune system activation.