On March 23, 2026, Theriva Biologics, Inc. (NYSE American: TOVX) announced the outcomes of a recent Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the design of a Phase 3 clinical study of its lead clinical candidate, VCN-01, in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic adenocarcinoma (PDAC). The FDA provided general agreement with the proposed design for the Phase 3 clinical trial, which closely follows the successful design of the VIRAGE Phase 2 trial. The VIRAGE trial had previously met its primary endpoints, demonstrating improved overall survival (OS), progression-free survival (PFS), and duration of response (DoR) for patients receiving VCN-01 alongside standard chemotherapy compared to those receiving chemotherapy alone. Notably, patients who received two doses of VCN-01 showed even greater improvements in OS and PFS. As a result, Theriva plans to include repeat dosing and an adaptive design in the upcoming Phase 3 trial to optimize timelines and outcomes. The FDA also indicated that a potential biologics licensing application (BLA) for VCN-01 could be supported by the proposed Phase 3 trial if successful. This trial will compare VCN-01 plus gemcitabine/nab-paclitaxel to gemcitabine/nab-paclitaxel plus placebo, with the FDA agreeing on the proposed dosing and key endpoints. The positive feedback from both the FDA and the European Medicines Agency (EMA) allows Theriva to finalize the protocol for the pivotal Phase 3 clinical trial while pursuing strategic funding opportunities. Steven A. Shallcross, CEO of Theriva Biologics, expressed optimism about the alignment with the FDA on key trial elements, emphasizing the potential for VCN-01 to provide a novel treatment option for patients with this challenging cancer type.

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