Theriva Biologics Clears FDA Hurdle for Phase 3 Trial of VCN-01 in Pancreatic Cancer
Event summary
- Theriva Biologics received positive feedback from the FDA on the design of a Phase 3 trial for VCN-01 in combination with standard-of-care chemotherapy for metastatic pancreatic ductal adenocarcinoma (PDAC).
- The Phase 3 trial will use an adaptive design and include repeat dosing of VCN-01, following the successful VIRAGE Phase 2 trial which showed improved overall survival (OS), progression-free survival (PFS), and duration of response (DoR).
- The FDA agreed on the proposed dosing, inclusion/exclusion criteria, primary endpoint (overall survival), and key secondary endpoints (including progression-free survival).
- Theriva Biologics plans to finalize the protocol for the Phase 3 trial and pursue development funding and/or partnerships.
The big picture
Theriva Biologics' positive FDA meeting marks a critical step in advancing VCN-01, an oncolytic adenovirus designed to treat metastatic pancreatic cancer. The strategic alignment with both U.S. and European regulators sets the stage for a pivotal Phase 3 trial, addressing a high unmet need in oncology. The company's ability to secure funding and partnerships will be key to navigating the next phase of development.
What we're watching
- Trial Execution
- Whether the adaptive design of the Phase 3 trial will optimize timelines and outcomes for VCN-01 in metastatic PDAC.
- Funding Strategy
- The pace at which Theriva Biologics secures development funding or partnerships to advance the Phase 3 trial.
- Regulatory Pathway
- How the combined feedback from the FDA and EMA will influence the potential biologics licensing application (BLA) for VCN-01.
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