Theriva Biologics, Inc. 8-K

What Happened

• On December 29, 2025, Theriva Biologics, Inc. announced receipt of scientific advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on its proposed Phase 3 trial of VCN‑01 combined with gemcitabine/nab‑paclitaxel for first‑line treatment of metastatic pancreatic adenocarcinoma (PDAC).
• CHMP agreed that a single, high‑quality, double‑blind, randomized, placebo‑controlled Phase 3 trial could support a future marketing authorization application (MAA) if it demonstrates a compelling benefit‑risk profile for VCN‑01 plus standard‑of‑care (SoC) versus SoC alone.

Key Details

• Date of disclosure: December 29, 2025 (press release / Form 8‑K filed).
• CHMP agreement: inclusion/exclusion criteria, primary endpoint = overall survival; secondary endpoints include progression‑free survival, duration of response, and patient‑reported outcomes.
• Trial design elements: randomized, double‑blind, placebo‑controlled Phase 3 with agreed sample size and use of an adaptive design to optimize timelines/outcomes.
• Dosing: CHMP recognized greater benefit in patients receiving two doses of VCN‑01 (as seen in the VIRAGE Phase 2b trial), agreed with proposed repeated “macrocycle” dosing enabling >2 doses, and suggested the possibility of more frequent dosing.

Why It Matters

• For investors, CHMP scientific advice is an important regulatory milestone: it signals that European regulators broadly support the company’s planned Phase 3 trial design and endpoints, which can reduce regulatory risk and help streamline development planning.
• The CHMP’s recognition of positive Phase 2b (VIRAGE) signals for overall survival and agreement on key trial elements increases the likelihood that a successful Phase 3 could form the basis of an MAA in metastatic PDAC. However, CHMP support is advisory — approval will depend on actual Phase 3 results.