Theriva Biologics to Present Expanded VCN-01 Data and Next-Generation VCN-12 Oncolytic Adenovirus at Major Medical Conferences
Key Insights
Theriva Biologics will present expanded data from the VIRAGE Phase 2b trial of VCN-01 in metastatic pancreatic cancer (search) at ESMO 2025, building on previous clinical results from 142 patients treated across multiple cancer types.
The company will showcase preclinical data for VCN-12 (search), a next-generation oncolytic adenovirus armed with additional transgenes designed to improve tumor cell lysis and enhance stroma degradation compared to VCN-01.
New preclinical research demonstrates the feasibility of intracranial VCN-01 administration for brain tumor treatment, with investigators concluding the findings provide strong rationale for further development in this indication.
Theriva Biologics will present expanded clinical data from its lead oncolytic adenovirus VCN-01 and unveil preclinical findings for next-generation candidate VCN-12 (search) at upcoming major medical conferences, highlighting the company's advancing pipeline in cancer virotherapy.
VIRAGE Trial Data to Feature at ESMO 2025
The company will present expanded data from the VIRAGE Phase 2b trial investigating VCN-01 (zabilugene almadenorepvec (search)) in metastatic pancreatic ductal adenocarcinoma (search) (mPDAC) at the European Society for Medical Oncology Annual Congress. Dr. Rocío Garcia-Carbonero from Hospital 12 de Octubre (search) in Madrid will deliver the mini-oral presentation on October 20, 2025, detailing results from the randomized, open-label study comparing nab-paclitaxel and gemcitabine with or without intravenous VCN-01.
VCN-01 represents a systemically administered oncolytic adenovirus designed to selectively replicate within tumor cells while degrading the tumor stroma (search) that serves as a physical and immunosuppressive barrier to cancer treatment. The therapeutic exerts multiple antitumor effects by selectively infecting and lysing tumor cells, enhancing access and perfusion of co-administered chemotherapy products, and increasing tumor immunogenicity to expose tumors to the patient's immune system.
To date, VCN-01 has been administered to 142 patients across clinical trials in different cancers, including pancreatic ductal adenocarcinoma in combination with chemotherapy, head and neck squamous cell carcinoma (search) with immune checkpoint inhibitors, ovarian cancer (search) with CAR-T cell therapy, colorectal cancer (search), and retinoblastoma (search) via intravitreal injection.
Next-Generation VCN-12 Platform Advances
At the 32nd Annual Congress of the European Society of Gene & Cell Therapy in Seville, Spain, Dr. Ramón Alemany will present new mechanistic and preclinical data for VCN-12 (search), a next-generation oncolytic adenovirus selected from Theriva's VCN-X discovery program. VCN-12 is derived from VCN-01 and is armed with additional transgenes designed to improve tumor cell lysis, enhance stroma degradation, and augment the antitumor immune response.
Dr. Alemany, co-founder of VCN Biosciences (search) and Head of the Immunotherapy and Virotherapy Group at the ProCURE Program of the Catalan Institute of Oncology, will deliver the presentation titled "Cancer Virotherapy with Armed Oncolytic Adenoviruses" on October 8, 2025.
Brain Tumor Application Shows Promise
A recently published pre-ESGCT meeting monograph details preclinical study results conducted by investigators at the University of Navarra evaluating intracranial administration of VCN-01 for potential brain tumor treatment. The authors highlighted the urgent need to develop new and improved therapies for brain cancers and concluded that their findings "provide a strong rationale for its [VCN-01] further development as a therapeutic option for patients with brain tumors (search)."
SYN-004 Safety Data at IDWeek 2025
Theriva will also present previously disclosed blinded safety and pharmacokinetic data from the ongoing Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant recipients for prevention of acute graft-versus-host-disease (search). Dr. Erik R. Dubberke from Washington University School of Medicine will present the safety and tolerability data at IDWeek 2025 in Atlanta on October 20, 2025.
SYN-004 is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as vancomycin-resistant Enterococci and reducing the incidence and severity of acute graft-versus-host-disease (search) in allogeneic hematopoietic cell transplant recipients.