Theriva Biologics to Present Key VIRAGE Phase 2b Trial Data for VCN-01 in Metastatic Pancreatic Cancer at AACR 2026

Highlights for Investors

• Upcoming Data Presentation: Theriva Biologics (NYSE American: TOVX) will present new data and subgroup analyses from the VIRAGE Phase 2b clinical trial of VCN-01 (zabilugene almadenorepvec) plus gemcitabine/nab-paclitaxel in newly diagnosed metastatic pancreatic cancer (mPDAC) patients at the AACR 2026 Annual Meeting in San Diego.
• Potential Price-Moving News: The company reports improved outcomes in VCN-01 treated patients across multiple subgroups, including those with liver metastases—an area of high unmet medical need and poor prognosis.
• Immune-Mediated Activity: Tumor response, biomarker, and subgroup analyses support an immune-mediated mode of action for VCN-01, potentially differentiating it from standard-of-care treatments.
• Regulatory Progress: Theriva has achieved alignment with both the FDA and EMA on the design of a pivotal Phase 3 trial to evaluate multiple doses of VCN-01 plus chemotherapy in first-line metastatic PDAC. This could significantly de-risk the regulatory pathway.
• Upcoming Studies: The company is planning a small study to assess whether more frequent and extended VCN-01 dosing could further improve patient outcomes.

Details of the AACR 2026 Presentation

• Presenting Author: Dr. Manuel Hidalgo, NYU Langone Health Perlmutter Cancer Center
• Title: Analysis of tumor and biomarker responses in the VIRAGE Trial, a randomized Phase IIb, open-label study of nab-paclitaxel and gemcitabine with/without intravenous VCN-01 in patients with metastatic pancreatic cancer (mPDAC)
• Poster #: CT162
• Date and Time: Monday, April 20, 2026, 2:00–5:00 PM PDT
• Session: PO.CT01.05 – Phase II and Phase III Clinical Trials
• Location: San Diego Convention Center, Hall B, Section 52, Board 26

Clinical and Scientific Significance

According to CEO Steven A. Shallcross, the new data and analyses reinforce confidence in the clinical potential of VCN-01 combined with gemcitabine/nab-paclitaxel to help metastatic PDAC patients. Notably, patients treated with VCN-01 in the VIRAGE trial experienced a significantly prolonged duration of response and longer survival compared to those receiving chemotherapy alone. These findings are particularly noteworthy given the aggressive nature of metastatic pancreatic cancer and the limited treatment options currently available.

The tumor response and biomarker data suggest that VCN-01 may work via immune-mediated mechanisms, offering a novel approach to treatment. This aligns with previous clinical observations of durable responses and survival benefits.

Importantly, Theriva’s alignment with leading regulatory agencies (FDA and EMA) on the pivotal Phase 3 trial design for first-line metastatic PDAC patients reduces regulatory risk. The company is also exploring whether more frequent and extended dosing of VCN-01 could further improve outcomes, which, if successful, could enhance the product’s competitive profile.

About VCN-01

VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus engineered to selectively replicate within tumor cells and degrade the tumor stroma—a major physical and immunosuppressive barrier in cancer treatment. VCN-01 is designed to:

• Infect and lyse tumor cells selectively
• Enhance delivery of co-administered chemotherapy
• Increase tumor immunogenicity, potentially boosting responses to immunotherapy

To date, 142 patients have received VCN-01 in trials for various cancers, including pancreatic ductal adenocarcinoma, head and neck squamous cell carcinoma, ovarian cancer (with CAR-T therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More details are available at Clinicaltrials.gov.

Theriva Biologics: Pipeline and Corporate Overview

Theriva Biologics is a diversified clinical-stage company targeting cancer and related diseases with high unmet needs. Its lead candidate, VCN-01, is being developed both as monotherapy and in combination with other cancer therapies. The company’s platform also includes SYN-004 (ribaxamase), an exploratory program designed to protect the gut microbiome during IV beta-lactam antibiotic treatment and reduce the risk of acute graft-versus-host disease (aGVHD) in certain transplant patients.

Risks and Considerations for Shareholders

• Regulatory Pathway: While alignment with FDA and EMA is a major milestone, successful progression to and through Phase 3, and ultimately regulatory approval, are not guaranteed.
• Development Funding: The company’s ability to secure sufficient funding or partnerships for Phase 3 development and commercialization remains crucial.
• Competitive Landscape: Advances by competitors or changes in the treatment paradigm could impact the market opportunity for VCN-01.
• Clinical Milestones: Timely patient enrollment, robust clinical data, and positive trial outcomes will be key for value creation and share price appreciation.
• Intellectual Property: Maintenance and growth of Theriva’s patent portfolio are essential for sustaining long-term value.

Investor Relations Contact

For further information, investors are encouraged to contact:
Kevin Gardner
LifeSci Advisors, LLC
[email protected]

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from expectations. Investors should review all relevant filings with the SEC and consult with their financial advisors before making investment decisions. Theriva Biologics undertakes no obligation to update forward-looking statements except as required by law.

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