ROCKVILLE, Md. - Theriva Biologics Inc. (NYSE American:TOVX) announced today that results from a Phase 1 clinical trial of VCN-01 in head and neck cancer patients have been published in Clinical Cancer Research.
The trial enrolled 20 patients with metastatic head and neck squamous cell carcinoma whose disease had progressed despite previous therapies, including immune checkpoint inhibitors. Patients received intravenous VCN-01, an oncolytic adenovirus, either concomitantly or sequentially with durvalumab, an immune checkpoint inhibitor.
According to the press release statement, median overall survival was 10.3 months for patients receiving low-dose VCN-01 four hours before durvalumab, 15.5 months for those receiving low-dose VCN-01 14 days before durvalumab, and 17.3 months for patients receiving high-dose VCN-01 14 days before durvalumab. Median progression-free survival ranged from 1.6 to 3.7 months across the three treatment arms.
The trial measured circulating levels of hyaluronidase enzyme PH20 and VCN-01 viral genome levels in patient blood samples. Tumor biopsies showed changes in various biomarkers, including upregulation of CD8, IDO, PD-1 and PD-L1, and reduced levels of FoxP3, CD25 and CTLA4.
"The trial demonstrates the ability of VCN-01 to resensitize tumors from these heavily pretreated patients to the immune checkpoint inhibitor durvalumab," said Ricard Mesia of the Catalan Institute of Oncology, coordinating investigator in the study.
The trial, registered as NCT03799744, divided patients into three arms with six patients in the concomitant low-dose arm, eight in the sequential low-dose arm, and six in the sequential high-dose arm.
Theriva Biologics is a clinical-stage company developing cancer therapeutics. The company’s subsidiary Theriva Biologics S.L. is developing the oncolytic adenovirus platform.With a market capitalization of $11.17 million and a current stock price of $0.24, the company trades below its InvestingPro Fair Value, suggesting potential upside for investors. According to InvestingPro Tips, the company holds more cash than debt on its balance sheet, though it is quickly burning through cash—typical characteristics for clinical-stage biotechnology firms. For deeper insights, investors can access TOVX’s comprehensive Pro Research Report, one of 1,400+ available on InvestingPro, which transforms complex data into actionable intelligence.
In other recent news, Theriva Biologics has been in the spotlight with several significant developments. The company announced new data from its VIRAGE Phase 2b clinical trial, which evaluated the combination of VCN-01 and chemotherapy in metastatic pancreatic cancer patients. This data was presented at the American Association for Cancer Research Annual Meeting, highlighting tumor response, biomarker data, and subgroup analyses. Additionally, Theriva Biologics received feedback from the U.S. Food and Drug Administration regarding its proposed Phase 3 trial design for VCN-01, with the FDA generally agreeing with the company’s plan. This trial aims to build on the success of the VIRAGE Phase 2 trial, which showed improved outcomes for patients. In corporate governance news, Theriva Biologics announced it would reschedule its Special Meeting of Stockholders due to a lack of quorum. The meeting was initially intended to address a warrant exercise proposal and an adjournment proposal. The company plans to announce a new meeting date and will provide details through proxy materials filed with the SEC.
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