Theriva Biologics (NYSE:TOVX) said it has received Scientific Advice from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on the design of a proposed Phase 3 trial evaluating VCN-01 in combination with gemcitabine and nab-paclitaxel for first-line treatment of metastatic pancreatic ductal adenocarcinoma.
The company said the CHMP agreed with overall survival as the primary endpoint and endorsed key secondary endpoints, inclusion and exclusion criteria, sample size, and the use of an adaptive trial design.
The regulator also supported repeated “macrocycle” dosing of VCN-01—more than two doses—following positive efficacy signals observed in the VIRAGE Phase 2b study.
Theriva said the proposed Phase 3 trial will be double-blind, randomized, and placebo-controlled, positioning the program for potential registration in Europe if successful.
In parallel, the company plans to hold an End-of-Phase 2 meeting with the U.S. Food and Drug Administration in the first half of 2026 to align on U.S. regulatory requirements.
As of its latest update, Theriva reported cash and cash equivalents of $15.5 million, which management said is expected to fund operations into the first quarter of 2027.
The company said the runway is sufficient to support regulatory interactions and partnering discussions related to the VCN-01 program.