--- title: "Theriva reports Phase 1 head and neck cancer results in journal" url: "https://aibio.space/news/theriva-reports-phase-1-head-neck-cancer-results-journal/" publisher: "aibio.space (Biotech Investor Relations News)" date: "2026-06-11" section: "Company Updates" tickers: "AMEX:TOVX" source: "https://www.sec.gov/Archives/edgar/data/894158/000110465926072633/tm2617564d1_ex99-1.htm" summary: "Clinical Cancer Research published the Phase 1 study of VCN-01 with durvalumab in patients whose cancer was refractory to immunotherapy." --- By the aibio.space news desk. Sources - [Theriva Biologics, Inc. 8-K (2026-06-11)](https://www.sec.gov/Archives/edgar/data/894158/000110465926072633/tm2617564d1_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/) 2026-06-11 # Theriva reports Phase 1 head and neck cancer results in journal Tickers [TOVX](https://aibio.space/companies/theriva-biologics/) Clinical Cancer Research published the Phase 1 study of VCN-01 with durvalumab in patients whose cancer was refractory to immunotherapy. ## Key facts - **Company**: Theriva Biologics, Inc. (AMEX: TOVX) - **News type**: Company Updates - **Primary source**: [Theriva Biologics, Inc. 8-K (2026-06-11)](https://www.sec.gov/Archives/edgar/data/894158/000110465926072633/tm2617564d1_ex99-1.htm) *Researchers loading samples into an automated instrument. Photo: Centers for Disease Control and Prevention, 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 June 11, 2026 that clinical and translational results from the Phase 1 trial of VCN-01 in head and neck cancer have been published online first in the journal Clinical Cancer Research. The paper reports a Phase I trial of intravenous VCN-01 with durvalumab in patients with metastatic head and neck squamous cell carcinoma whose disease no longer responded to immunotherapy. Ricard Mesia of the Catalan Institute of Oncology, the expert on head and neck cancer and coordinating investigator in the study, said: "The trial demonstrates the ability of VCN-01 to resensitize tumors from these heavily pretreated patients to the immune checkpoint inhibitor durvalumab." ## The trial design The trial, registered as NCT03799744, enrolled 20 adult patients with refractory or metastatic head and neck squamous cell carcinoma. All had progressed despite previous therapies, including anti-PD-(L)1 immune checkpoint inhibitors. Six patients joined the concomitant Arm I low-dose group. They received low-dose VCN-01 four hours before a fixed intravenous dose of durvalumab. Eight patients joined the sequential Arm II low-dose group, which received low-dose VCN-01 14 days before durvalumab. Six more patients joined the Arm II high-dose group, which received high-dose VCN-01 14 days before durvalumab. ## The reported results The release lists median progression-free survival of 1.6 months in Arm I low dose, 3.7 months in Arm II low dose and 2.1 months in Arm II high dose. Median overall survival was 10.3 months, 15.5 months and 17.3 months in the same three groups, respectively. The company reports several laboratory findings. Circulating levels of the enzyme PH20, which is expressed during selective VCN-01 replication in tumors, rose significantly after VCN-01 was given in all tested patients. Tumor biopsies showed higher levels of CD8 and IDO, consistent with more activated cytotoxic T cells in the tumor. Biopsies also showed higher PD-1 and PD-L1 expression in most patients after VCN-01, and that expression correlated with survival. The company says these pharmacokinetic, tissue biopsy, radiomic and transcriptomic results support the proposed stroma-degrading and immune-enhancing mode of action of VCN-01. The release says the findings encourage further clinical development of VCN-01 with immune checkpoint inhibitors or other immune modulating anticancer therapies. ## The company and its pipeline It acquired Theriva Biologics, S.L., formerly VCN Biosciences, S.L., in March 2022 and moved its strategic focus to oncology. Its lead candidate, VCN-01, has been evaluated in a Phase 2b study for pancreatic cancer, called VIRAGE, and a Phase 1 study for retinoblastoma. The company's gastrointestinal program continues in a limited form. An exploratory clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant recipients has completed 2 of 3 cohorts. The third cohort depends on additional funding. In February 2026, the company granted Rasayana Therapeutics, Inc. an exclusive worldwide license to SYN-020, and Rasayana assumes responsibility and costs for its development and commercialization. ## Financial position The company's 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. Year-end cash and cash equivalents were $11.6 million at the end of 2024. ## The risks ahead This was a Phase 1 study of 20 patients with no comparison group, split into groups of six, eight and six, so the survival figures rest on very few people. Median progression-free survival in the three groups ran from 1.6 to 3.7 months. The release's data summary reports no response rates and no safety findings, and the biomarker results show changes in tumor tissue, not proof that patients benefited. The release says the findings encourage further development, but it does not set a date for the next trial. Cash from operations was negative $16.7 million in 2025, against year-end 2024 cash and cash equivalents of $11.6 million, so any new trial needs funding. The filings say the third cohort of the SYN-004 study depends on additional funding, and that the company is exploring out-licensing or partnering for that asset. [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 reports Phase 1 head and neck cancer results in journal", 2026-06-11, https://aibio.space/news/theriva-reports-phase-1-head-neck-cancer-results-journal/