--- title: "Theriva receives Spanish authorization for VIRAGE2 trial" url: "https://aibio.space/news/theriva-receives-spanish-authorization-virage2-trial/" publisher: "aibio.space (Biotech Investor Relations News)" date: "2026-07-07" section: "Company Updates" tickers: "AMEX:TOVX" source: "https://www.sec.gov/Archives/edgar/data/894158/000110465926080962/tm2619846d1_ex99-1.htm" summary: "Spain's AEMPS cleared the Phase 2a study of more frequent VCN-01 dosing in first-line metastatic pancreatic cancer." --- By the aibio.space news desk. Sources - [Theriva Biologics, Inc. 8-K (2026-07-07)](https://www.sec.gov/Archives/edgar/data/894158/000110465926080962/tm2619846d1_ex99-1.htm) - [Theriva Biologics, Inc. 10-K (2026-03-12): business](https://www.sec.gov/Archives/edgar/data/894158/000110465926026767/tmb-20251231x10k.htm) - [Theriva Biologics, Inc. financial data (SEC XBRL)](https://www.sec.gov/Archives/edgar/data/894158/000110465926026767/) [TOVX](https://aibio.space/companies/theriva-biologics/) 2026-07-07 # Theriva receives Spanish authorization for VIRAGE2 trial Tickers [TOVX](https://aibio.space/companies/theriva-biologics/) Spain's AEMPS cleared the Phase 2a study of more frequent VCN-01 dosing 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 (2026-07-07)](https://www.sec.gov/Archives/edgar/data/894158/000110465926080962/tm2619846d1_ex99-1.htm) *Laboratory flasks filled with white solution. CC0, via rawpixel. The picture shows the field, not the companies named.* Theriva Biologics, Inc. (NYSE American: [TOVX](https://aibio.space/companies/theriva-biologics/)) said on July 7, 2026 that the Spanish Agency of Medicines and Medical Devices, AEMPS, has authorized it to start the VIRAGE2 clinical trial. The study will test more frequent dosing of VCN-01 (zabilugene almadenorepvec) in combination with gemcitabine/nab-paclitaxel chemotherapy in patients with newly diagnosed metastatic pancreatic cancer. The company's release, filed as Exhibit 99.1 to a Current Report on Form 8-K, calls the trial a Phase IIa, single-arm, single-center, open-label proof-of-concept study. It does not give a date for the first patient to be dosed. ## The earlier study behind the trial VIRAGE2 builds on the VIRAGE Phase 2b trial, which enrolled 112 patients with treatment-naive metastatic pancreatic ductal adenocarcinoma. In that trial, patients who received two doses of VCN-01 given 3 months apart had, in the company's words, significantly improved overall survival, progression-free survival and duration of response compared with patients who received one dose of VCN-01 or standard chemotherapy alone. The release gives no p-values, hazard ratios or per-arm patient numbers. The company says both the European Medicines Agency and the U.S. Food and Drug Administration recognized the improved survival in the two-dose group. Both raised the possibility of more frequent, repeated dosing of VCN-01 with standard chemotherapy to improve clinical outcomes. "We expect more frequent repeated dosing of VCN-01 to enable more potent degradation of the tumor stroma and elicit earlier induction of an antitumor immune response," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. He said the primary objective is to determine whether more frequent repeated dosing is well tolerated and does not adversely affect VCN-01 levels in the body. ## The trial design The release describes VIRAGE2 as a trial in 6 evaluable patients enrolled at a single site in Spain. Patients are intended to receive at least three macrocycles of VCN-01 and gemcitabine/nab-paclitaxel standard-of-care chemotherapy, followed by standard chemotherapy cycles until disease progression. 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 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. Exploratory endpoints include estimates of possible VCN-01 shedding, measured as viral genomes in sputum and stool. The study is designed with 80% power to detect a difference in VCN-01 viral genome levels between the second and first VCN-01 doses, using a two-sided alpha of 0.05. The company says it is not formally powered to evaluate clinical efficacy. ## About VCN-01 and the company VCN-01 is a systemically administered oncolytic adenovirus. The release says VCN-01 has been given to 142 patients to date in company and investigator-sponsored trials, including trials in pancreatic cancer with chemotherapy, head and neck cancer with an immune checkpoint inhibitor, ovarian cancer with CAR-T cell therapy, colorectal cancer and retinoblastoma. Theriva acquired Theriva Biologics, S.L., formerly VCN Biosciences, S.L., in March 2022 and moved its focus to oncology. Its annual report, filed on March 12, 2026, describes VCN-01 as the lead clinical-stage product candidate. ## Financial position The annual report shows research and development expense of $8.6 million for 2025, down from $12.0 million for 2024. Cash from operations was negative $16.7 million in 2025 and negative $16.9 million in 2024. Year-end cash and cash equivalents were $11.6 million at the end of 2024. ## The risks ahead The company has to dose its first patient, and the release gives no date for that. VIRAGE2 is small: 6 evaluable patients at a single site, and the company says it is not formally powered to evaluate clinical efficacy. A pivotal Phase 3 trial is only a possibility that VIRAGE2 results will inform, and the release gives no timetable for it. The annual report shows cash from operations of negative $16.7 million in 2025 and negative $16.9 million in 2024, so the company will need to fund continued trial work. The filings also say it is exploring out-licensing or partnering for SYN-004. [Report an error](https://aibio.space/reputation/#correction) ## Companies in this story TOVX Theriva Biologics, Inc. 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Cite as: aibio.space, "Theriva receives Spanish authorization for VIRAGE2 trial", 2026-07-07, https://aibio.space/news/theriva-receives-spanish-authorization-virage2-trial/