Theriva Biologics Inc. is a clinical-stage biotechnology firm dedicated to developing novel treatments for conditions with significant unmet medical needs. The company's pipeline features several promising candidates, including SYN-004, which is engineered to break down commonly used intravenous beta-lactam antibiotics in the gastrointestinal tract. This degradation aims to avert microbiome damage, Clostridioides difficile infection (CDI), the overgrowth of harmful organisms, the rise of antimicrobial resistance (AMR), and acute graft-versus-host disease (aGVHD) in patients undergoing allogeneic hematopoietic cell transplants. Another key investigational therapy is SYN-020, an orally administered recombinant formulation of intestinal alkaline phosphatase, designed to address both localized gastrointestinal and systemic diseases. Additionally, Theriva Biologics is advancing VCN-01 for the treatment of various cancers, specifically pancreatic cancer, head and neck squamous cell carcinoma, colorectal cancer, and retinoblastoma. Its broader clinical-stage portfolio includes SYN-006, intended to prevent aGVHD and infections caused by carbapenem-resistant enterococci; SYN-007, aimed at preventing antibiotic-associated diarrhea linked to oral beta-lactam antibiotics; SYN-005, for both the prevention and treatment of pertussis; and VCN-11, another cancer-focused therapy. The company collaborates with institutions such as Intrexon Corporation, The University of Texas at Austin, and Cedars-Sinai Medical Center. Furthermore, a clinical trial agreement with Washington University School of Medicine in St. Louis is in place to conduct a Phase 1b/2a clinical trial for SYN-004. Formerly known as Synthetic Biologics, Inc., the company rebranded as Theriva Biologics Inc. in October 2022 and is headquartered in Rockville, Maryland.
Theriva™ Biologics Announces Publication of the Results from the VIRAGE Phase 2b Clinical Trial of VCN-01 in Metastatic Pancreatic Cancer Published in Nature Medicine
Theriva Biologics announced peer-reviewed publication of VIRAGE Phase 2b results for VCN-01 in metastatic pancreatic cancer in Nature Medicine.
The published data show improved overall survival, progression-free survival, and duration of response when VCN-01 was added to gemcitabine/nab-paclitaxel chemotherapy versus chemotherapy alone, with greater benefit in patients receiving 2 doses 3 months apart.
The company is evaluating more frequent dosing in the VIRAGE2 Phase 2a trial (first patient dosed August 2026, enrollment expected to complete in H2 2026, data by Q3 2027), which will inform a potential pivotal Phase 3, and is also engaging the FDA on a possible Phase 2/3 retinoblastoma study.