Key insights
- Theriva Biologics' VCN-01 trial results for metastatic pancreatic cancer were published in Nature Medicine, showing improved survival and progression-free survival compared to chemotherapy alone. The drug, VCN-01, is being further evaluated in a Phase 2a study for pancreatic cancer and a potential Phase 2/3 study for pediatric retinoblastoma. These positive results and ongoing development suggest a favorable outlook for the company.
Theriva Biologics (NYSE American: TOVX) announced that results from its VIRAGE Phase 2b clinical trial of VCN-01 (zabilugene almadenorepvec) in metastatic pancreatic cancer patients were published in Nature Medicine, according to a company statement.
The trial enrolled 112 patients across 14 sites in the U.S. and Spain. Patients in the VCN-01 treatment arm received intravenous VCN-01 seven days prior to the first and fourth cycles of standard-of-care gemcitabine/nab-paclitaxel chemotherapy. The control arm received chemotherapy alone.
Patients treated with VCN-01 combined with chemotherapy showed improved overall survival, progression-free survival, and duration of response compared to those receiving chemotherapy alone, according to the publication. Greater improvements were observed in patients who received two doses of VCN-01 administered three months apart.
"The Kaplan-Meier survival analysis and the timing of responses in VCN-01 treated patients suggest an immune mediated mechanism of action for VCN-01 in addition to its stroma degrading effects," said Manel Cascalló, PhD, General Director of Theriva Biologics S.L. and co-author of the article.
Following feedback from both the European Medicines Agency and the U.S. Food and Drug Administration, Theriva has initiated VIRAGE2, a Phase 2a study evaluating more frequent, repeated dosing of VCN-01 in combination with standard-of-care chemotherapy. The trial enrolled its first patient in August 2026 and is expected to complete enrollment in the second half of 2026. Initial pharmacodynamic and safety data are anticipated by Q3 2027.
Separately, Theriva is working with the FDA to finalize the design of a potential Phase 2/3 study evaluating VCN-01 in pediatric retinoblastoma patients with vitreous seeds that are resistant to current intravitreal chemotherapy. VCN-01 holds Rare Pediatric Disease designation for retinoblastoma and could qualify for a Priority Review Voucher if approved in that indication by September 30, 2029.
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