Positive Scientific Advice from EMA on the Design of a Ph 3 Trial of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Announced
“We are very encouraged by the scientific advice we received from the EMA regarding our proposed pivotal Phase 3 trial of VCN-01 plus gemcitabine/nab-paclitaxel SoC in metastatic PDAC patients,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “We are particularly pleased with EMA agreement on the VCN-01 macrocycle dosing regimen. As we demonstrated in the VIRAGE Phase 2b study, patients who received 2 doses of VCN-01 had improved survival outcomes, therefore we anticipate 3 or more doses of VCN-01 should provide an even greater survival benefit. We plan to complete an End-of-Phase 2 meeting with the FDA in the first half of 2026 and finalize the protocol for a pivotal multinational Phase 3 trial, intended to deliver an innovative therapeutic option for patients diagnosed with this rapidy fatal disease. We recognize that regulatory clarity on development pathways is essential for the on-going partnering efforts for our VCN-01 clinical programs. In addition to regulatory advice on the proposed PDAC Phase 3 clinical trial, interactions with EMA and FDA are planned in 2026 to seek advice on a potential Phase 2/3 trial for VCN-01 in retinoblastoma, a challenging childhood cancer for which VCN-01 has been granted Rare Pediatric Disease designation.”
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