Theriva Advances Design With FDA Guidance For VCN-01 Pancreatic Cancer Trial

Theriva™ Biologics is a clinical-stage company focused on developing therapies for cancer and related diseases with high unmet needs. The firm has shared the results of a recent Type D meeting with the U.S. Food and Drug Administration (FDA). The meeting guided the design of a Phase 3 clinical trial for the company’s lead candidate, VCN-01, in combination with standard-of-care chemotherapy to treat metastatic pancreatic adenocarcinoma (PDAC). Theriva recently completed target enrolment for the multinational VIRAGE Phase 2b trial, assessing intravenous VCN-01 alongside gemcitabine/nab-paclitaxel as a first-line treatment for PDAC. 

Steven A. Shallcross, Chief Executive Officer of Theriva Biologics, said in a statement, “The FDA’s advice on key elements of a potential confirmatory Phase 3 study evaluating VCN-01 plus gemcitabine/nab-paclitaxel as a first-line treatment for metastatic PDAC patients is critical as the VIRAGE study has entered final patient follow-up and we are actively planning the next steps in VCN-01 development. The feedback from the FDA and European regulatory agencies will facilitate the design of a Phase 3 study protocol expected to maximise our ability to provide a new therapeutic option to patients suffering this terrible disease.”

Type D meetings typically address specific issues at critical decision points, offering timely feedback to advance drug development. During this meeting, the FDA advised against expanding the ongoing VIRAGE Phase 2b trial into a Phase 3 study. Instead, it recommended conducting a new, stand-alone Phase 3 trial evaluating VCN-01 with gemcitabine/nab-paclitaxel. The FDA generally agreed with Theriva’s proposed Phase 3 study design and noted that adding additional standard-of-care chemotherapies would unnecessarily complicate the trial. The discussion also covered statistical considerations for confirmatory trials, including sample size estimation and data analysis strategies. Theriva plans to meet with the FDA again after completing the VIRAGE study to finalise the Phase 3 trial protocol details.