Theriva Biologics, Inc. TOVX
Theriva Biologics, Inc. (NYSE: TOVX) is an oncology drug developer. Its lead program, VCN-01 (zabilugene almadenorepvec), is in Phase 2 for metastatic pancreatic ductal adenocarcinoma (with gemcitabine/nab-paclitaxel). Its next catalyst on record is VCN-01 retinoblastoma: First patient enrolled in Phase 2/3 (if protocol agreed) (January 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: VCN-01 retinoblastoma — First patient enrolled in Phase 2/3 (if protocol agreed) (January 2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| VCN-01 VIRAGE (Phase 2b, completed; met primary endpoints) | metastatic pancreatic ductal adenocarcinoma | gene therapy | Phase 2 |
| VCN-01 VIRAGE2 (Phase 2a, more frequent dosing) | newly diagnosed metastatic pancreatic cancer | gene therapy | Phase 2 |
| SYN-004 (ribaxamase) Phase 1b/2a, third cohort paused pending grant funding or partner | acute graft-versus-host disease prevention in allo-HCT recipients | protein/peptide | Phase 2 |
| VCN-01 + topotecan (intravitreal; Phase 1 completed, compassionate use) | retinoblastoma | gene therapy | Phase 1 |
| VCN-01 + durvalumab (Phase 1, published) | recurrent/metastatic head and neck squamous cell carcinoma | gene therapy | Phase 1 |
| SYN-020 (out-licensed to Rasayana; licensee responsible) | GI and systemic diseases | protein/peptide | Phase 1 |
| VCN-12 (VCN-X discovery program) | solid tumors | gene therapy | Pre-clinical |
Recent results and decisions
- Aug 6, 2026started First patient dosed in the single-arm, 6-patient VIRAGE2 Phase 2a study of more frequent VCN-01 dosing with gemcitabine/nab-paclitaxel in first-line metastatic PDAC.
today announced the dosing of the first patient in the VIRAGE2 Phase 2a clinical trial, a small proof-of-concept study evaluating more frequent repeated dosing of VCN-01
Filing - May 5, 2026positive Additional VIRAGE Phase 2b subgroup and biomarker analyses presented at AACR 2026 showed improved OS across subgroups including liver metastases and may reflect an immune-mediated mechanism; no numbers given.
Improved overall survival was observed in VCN-01-treated patients across multiple subgroups, including patients with liver metastases.
Filing - Mar 23, 2026n/a FDA gave general agreement at Type B End-of-Phase 2 meeting to the proposed single randomized Phase 3 design of VCN-01 plus gemcitabine/nab-paclitaxel (OS primary endpoint) that could support a BLA.
The FDA provided general agreement with Theriva’s proposed design for a Phase 3 clinical trial, which closely tracks the design of the successful VIRAGE Phase 2 trial.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 oncology companies
- Tango Therapeutics, Inc. TNGX
- Tyra Biosciences, Inc. TYRA
- Verastem, Inc. VSTM
- Obsidian Therapeutics, Inc. OBX
- Puma Biotechnology, Inc. PBYI
- Fulgent Genetics, Inc. FLGT
- Delcath Systems, Inc. DCTH
- Unknown Unknown
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.