aibioTheriva doses first patient in VIRAGE2 pancreatic cancer trial
Tickers TOVX
The Phase 2a study will test more frequent repeated dosing of VCN-01 with standard chemotherapy in first-line metastatic pancreatic cancer.
Key facts
- Company
- Theriva Biologics, Inc. (AMEX: TOVX)
- News type
- Company Updates
- Primary source
- Theriva Biologics, Inc. 8-K (2026-08-06)
Theriva Biologics, Inc. (NYSE American: TOVX) said on August 6, 2026 that it has dosed the first patient in VIRAGE2, a Phase 2a clinical trial of more frequent repeated dosing of its lead candidate, VCN-01 (zabilugene almadenorepvec). The study enrolls people with newly diagnosed metastatic pancreatic ductal adenocarcinoma, or PDAC, who receive VCN-01 together with standard-of-care gemcitabine/nab-paclitaxel chemotherapy. The company describes it as a small proof-of-concept study.
"The first patient dosed in VIRAGE2 marks an important clinical development milestone," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics, in the press release.
The trial design
The release describes VIRAGE2 as a Phase 2a, single-arm, open-label trial in 6 evaluable patients with histologically confirmed, newly diagnosed metastatic PDAC. It is enrolled at a single site in Spain. Patients are intended to receive at least three macrocycles of VCN-01 with gemcitabine/nab-paclitaxel chemotherapy, followed by standard chemotherapy cycles until the disease progresses. In each macrocycle, VCN-01 is given intravenously on day 1, and chemotherapy follows on days 8, 15, 22, 36, 43, and 50. The macrocycles repeat on days 57 and 113.
The primary objective is to evaluate whether at least 3 doses of VCN-01, given with about 2 months between doses, are well tolerated without adversely affecting VCN-01 pharmacodynamics. The primary endpoints are the adverse event profile and the levels of VCN-01 viral genomes in blood. Secondary endpoints include objective response rate, duration of response, progression free survival, overall survival, and circulating levels of anti-VCN-01 neutralizing antibodies.
The study is designed with 80% power to detect a difference in VCN-01 viral genome levels between the second and first doses, with a two-sided alpha of 0.05. The company says the study is not formally powered for clinical efficacy endpoints. Enrollment is expected to be completed in H2 2026, and initial pharmacodynamic and safety and tolerability data are anticipated by Q3 2027.
Why the dosing question matters
The trial builds on the VIRAGE Phase 2b study in metastatic PDAC. The company says patients in that study who received two doses of VCN-01 with standard chemotherapy had improved overall survival, progression-free survival and duration of response compared with chemotherapy alone, but the release gives no p-values, hazard ratios or patient numbers for that comparison. The company says the European Medicines Agency and the U.S. Food and Drug Administration both recognized the improved survival in the two-dose group. Both agencies also raised the possibility of more frequent, repeated dosing of VCN-01 with standard chemotherapy.
The company and its pipeline
Theriva describes itself as a diversified clinical-stage company developing therapeutics for cancer and related diseases in areas of high unmet need. It moved its focus to oncology in March 2022 by acquiring Theriva Biologics, S.L.
The release says VCN-01 has been given to 143 patients in company and investigator-sponsored trials, including trials in pancreatic cancer, head and neck squamous cell carcinoma, ovarian cancer, colorectal cancer and retinoblastoma. In February 2026 it granted Rasayana Therapeutics, Inc. an exclusive worldwide license to SYN-020. Under that agreement, Rasayana assumes all responsibility and costs for development and commercialization. The company says it is also exploring value creation options for SYN-004, including out-licensing or partnering.
Financial position
The annual report shows research and development expense of $8.6 million for 2025, compared with $12.0 million for 2024. Cash from operations was negative $16.7 million in 2025 and negative $16.9 million in 2024. Cash and cash equivalents were $11.6 million at the end of 2024.
The risks ahead
VIRAGE2 is small: 6 evaluable patients at one site, and the company says it is not formally powered for clinical efficacy. Pharmacodynamic and safety data are not expected until Q3 2027. Cash used in operations of $16.7 million in 2025 was larger than the $11.6 million of cash on hand at the end of 2024. The company says the results will shape the dosing plan for a proposed pivotal Phase 3 trial, which it has not yet begun. The filings also say completion of another trial is pending grant funding or a partnership, and that SYN-004 may be out-licensed or partnered.