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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 (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.
Theriva Biologics (NYSE: TOVX) will present Phase 1 clinical outcomes and safety data for VCN-01 in refractory retinoblastoma at APAO 2026 in Hong Kong on 07 February 2026.
The invited session includes intravitreal two-injection trial results (NCT03284268), preclinical data showing synergy with topotecan, presentation logistics, and note of Orphan Drug and Rare Pediatric Disease designations and ongoing pivotal trial planning.