Theriva Biologics, Inc. develops therapeutics for cancer and related diseases as a diversified clinical-stage biotechnology company. Its subsidiary, Theriva Biologics, S.L., is developing an oncolytic adenovirus platform for intravenous, intravitreal and antitumoral delivery. The company’s lead candidate, VCN-01, is designed to replicate selectively within tumor cells and degrade the tumor stroma barrier associated with cancer treatment resistance.
Recurring Theriva Biologics news includes VCN-01 clinical data in metastatic pancreatic ductal adenocarcinoma and retinoblastoma, regulatory interactions with U.S. and European agencies, medical-conference presentations, and operational financial results. Coverage also includes SYN-004, or ribaxamase, for gastrointestinal degradation of certain IV beta-lactam antibiotics, and the licensed SYN-020 recombinant intestinal alkaline phosphatase program.
Theriva Biologics (TOVX) announced publication in Nature Medicine of its VIRAGE Phase 2b trial results for VCN-01 in metastatic pancreatic cancer. The randomized, open-label trial enrolled 112 patients. VCN-01 plus gemcitabine/nab-paclitaxel chemotherapy improved overall survival, progression-free survival and duration of response versus chemotherapy alone. Greater improvements occurred in patients receiving two VCN-01 doses three months apart.
The first patient in VIRAGE2, testing more frequent repeated dosing, was treated in August 2026. Theriva expects enrollment completion in the second half of 2026 and initial data on biological activity and safety/tolerability by Q3 2027. The six-evaluable-patient study is not formally powered to evaluate clinical efficacy; results will inform dosing for a potential Phase 3 trial. Theriva is also engaging with the FDA on a potential Phase 2/3 retinoblastoma study.
Theriva Biologics (NYSE American: TOVX) reported second quarter 2026 results and operational updates, highlighting first patients dosed in the VIRAGE2 Phase 2a trial of VCN-01 in newly diagnosed metastatic pancreatic cancer, evaluating at least three doses about two months apart plus standard chemotherapy in six evaluable patients.
Initial pharmacodynamic and safety/tolerability data are anticipated by Q3 2027, with enrollment expected to complete in H2 2026. The company finalized a proposed Phase 2/3 retinoblastoma protocol and reported published Phase 1 data in refractory head and neck cancer. Q2 2026 net loss was $3.2 million versus $13.1 million a year earlier, with cash and cash equivalents of $11.3 million and an expected cash runway into Q1 2027.
Theriva Biologics (NYSE American: TOVX) announced dosing of the first patient in VIRAGE2, a Phase 2a, single-arm, open-label clinical trial of more frequent repeated dosing of VCN-01 (zabilugene almadenorepvec) with gemcitabine/nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma (PDAC). VIRAGE2 will enroll 6 evaluable patients at a single site in Spain, with enrollment expected to complete in H2 2026 and initial pharmacodynamic and safety/tolerability data anticipated by Q3 2027.
The study aims to assess whether at least three VCN-01 doses, given about two months apart in defined “macrocycles,” are well tolerated without adversely impacting VCN-01 pharmacodynamics. Primary endpoints are adverse events and VCN-01 viral genome levels in blood; secondary endpoints include response, progression-free and overall survival, and neutralizing antibodies. VIRAGE2 builds on prior VIRAGE Phase 2b observations of improved survival with two VCN-01 doses plus standard chemotherapy versus chemotherapy alone and is intended to refine dosing for a potential future pivotal Phase 3 trial.
Theriva Biologics (NYSE American:TOVX) received regulatory authorization from the Spanish Agency of Medicines and Medical Devices to start the VIRAGE2 Phase 2a trial of VCN-01 (zabilugene almadenorepvec) in first-line metastatic pancreatic ductal adenocarcinoma.
The single-arm, open-label study will test more frequent VCN-01 dosing with gemcitabine/nab-paclitaxel to refine the regimen for a potential future pivotal Phase 3 trial.
Theriva Biologics (NYSE American:TOVX) reported Phase 1 results of IV VCN-01 plus durvalumab in metastatic, immunotherapy-refractory head and neck squamous cell carcinoma.
The 20-patient trial showed prolonged overall survival (up to 17.3 months) and pharmacokinetic and biomarker changes consistent with VCN-01’s stroma-degrading and immune-enhancing mechanisms.
Theriva Biologics (NYSE: TOVX) reported Q1 2026 operational highlights and results, focusing on regulatory progress for lead candidate VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC) and retinoblastoma. The company aligned with the FDA on a Phase 3 PDAC design and presented VIRAGE Phase 2b data suggesting a possible immune-mediated mechanism.
Theriva made VCN-01 available for compassionate use in retinoblastoma, treated two patients, and expects a Spain dosing-feasibility study in H2 2026. Cash was $14.4 million at March 31, 2026, with runway into Q1 2027.
Theriva Biologics (NYSE American: TOVX) will present additional tumor response, biomarker, and subgroup analyses from the VIRAGE Phase 2b trial of VCN-01 plus gemcitabine/nab-paclitaxel at AACR 2026 in San Diego on April 20, 2026.
The poster (CT162) by Dr. Manuel Hidalgo reports data supporting an immune-mediated mode of action and improved outcomes across multiple subgroups, including patients with liver metastases. The company says it has alignment with the FDA and EMA on a proposed pivotal Phase 3 and plans a small dosing study to test more frequent/extended VCN-01 dosing.
Theriva Biologics (NYSE: TOVX) secured positive End-of-Phase 2 feedback from the U.S. FDA on March 23, 2026, enabling advancement to a proposed pivotal Phase 3 trial of VCN-01 plus gemcitabine/nab-paclitaxel for first-line metastatic pancreatic ductal adenocarcinoma (PDAC).
FDA agreed with the proposed randomized, double-blind design, repeat "macrocycle" dosing, primary endpoint of overall survival, key secondaries including PFS, and adaptive interim-analysis/statistical plans; combined FDA and EMA advice lets the company finalize protocol and pursue development funding or partnerships.
Theriva Biologics (NYSE: TOVX) reported full-year 2025 results and a corporate update on March 12, 2026. Key items: VCN-01 advancing toward pivotal PDAC Phase 3 after positive EMA scientific advice; SYN-020 licensed to Rasayana with up to $38 million in milestones plus royalties; cash of $13.1M at year-end and ~$15.2M as of Feb 26, 2026, funding operations into Q1 2027.
Theriva Biologics (NYSE American: TOVX) licensed SYN-020 to Rasayana Therapeutics in an exclusive, worldwide deal announced Feb 18, 2026. Theriva received a $300,000 upfront payment and may earn up to $38M in development, regulatory and sales milestones plus tiered single-digit royalties.
Rasayana will assume all development and commercialization costs; SYN-020 completed Phase 1 safety testing and is expected to enter Phase 2 under Rasayana's stewardship.