---
title: "Theriva to present VIRAGE trial biomarker data at AACR 2026"
url: "https://aibio.space/news/theriva-present-virage-trial-biomarker-data-aacr-2026/"
publisher: "aibio.space (Biotech Investor Relations News)"
date: "2026-04-17"
section: "Company Updates"
tickers: "AMEX:TOVX"
source: "https://www.sec.gov/Archives/edgar/data/894158/000110465926044906/tm2612012d1_ex99-1.htm"
summary: "A poster on April 20, 2026 will report tumor response, biomarker and subgroup analyses from the VIRAGE Phase 2b trial of VCN-01."
---

By the aibio.space news desk.

Sources

- [Theriva Biologics, Inc. 8-K (2026-04-17)](https://www.sec.gov/Archives/edgar/data/894158/000110465926044906/tm2612012d1_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/)

2026-04-17

# Theriva to present VIRAGE trial biomarker data at AACR 2026

Tickers [TOVX](https://aibio.space/companies/theriva-biologics/)

A poster on April 20, 2026 will report tumor response, biomarker and subgroup analyses from the VIRAGE Phase 2b trial of VCN-01.

## Key facts

- **Company**: Theriva Biologics, Inc. (AMEX: TOVX)

- **News type**: Company Updates

- **Primary source**: [Theriva Biologics, Inc. 8-K (2026-04-17)](https://www.sec.gov/Archives/edgar/data/894158/000110465926044906/tm2612012d1_ex99-1.htm)

*Laboratory flasks filled with white solution. CC0, via rawpixel. The picture shows the field, not the companies named.*

Theriva Biologics (NYSE American: [TOVX](https://aibio.space/companies/theriva-biologics/)) said on April 17, 2026 that it will present new data and subgroup analyses from the VIRAGE Phase 2b clinical trial of VCN-01 at the American Association for Cancer Research Annual Meeting in San Diego, California, held April 17 to 22, 2026. The company's poster covers tumor response, biomarker data and subgroup analyses in patients with metastatic pancreatic ductal adenocarcinoma, or PDAC.

## The poster

The presenting author is Dr. Manuel Hidalgo of the NYU Langone Health Perlmutter Cancer Center in New York. The poster is numbered CT162 and is titled as an analysis of tumor and biomarker responses in the VIRAGE trial. It is set in the session PO.CT01.05, Phase II and Phase III Clinical Trials, on Monday April 20, 2026, from 2:00-5:00 PM US PDT. The location is the San Diego Convention Center, Hall B, Section 52, Board 26.

The release describes VIRAGE as a randomized Phase IIb, open-label study of nab-paclitaxel and gemcitabine with or without intravenous VCN-01 in patients with metastatic pancreatic cancer. The company says the new analyses support an immune-mediated mode of action for VCN-01. It also says they show improved outcomes in VCN-01-treated patients across multiple subgroups, including patients with liver metastases.

"The new data and analyses to be presented at the AACR meeting further reinforce our confidence in the clinical potential of VCN-01 plus gemcitabine/nab-paclitaxel chemotherapy to help metastatic PDAC patients," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics, in the [announcement](https://www.sec.gov/Archives/edgar/data/894158/000110465926044906/tm2612012d1_ex99-1.htm).

## Earlier results and the regulatory path

Shallcross said the data are consistent with previously reported clinical observations. Those showed, the company says, that patients treated with VCN-01 plus gemcitabine and nab-paclitaxel had a significantly longer duration of response, along with a later prolongation of survival, compared with patients who received gemcitabine and nab-paclitaxel alone. The release gives no numbers, p-values or subgroup sizes, and VIRAGE was open-label, meaning patients and doctors knew who received VCN-01.

The company says it has reached alignment with both the U.S. Food and Drug Administration and the European Medicines Agency on a proposed pivotal Phase 3 trial. That trial would evaluate multiple doses of VCN-01 with gemcitabine and nab-paclitaxel in first-line metastatic PDAC patients. The company also plans a small study to assess whether more frequent and extended VCN-01 dosing could improve outcomes further.

## About VCN-01 and the company

VCN-01 is a systemically administered oncolytic adenovirus. The company says it replicates within tumor cells and degrades the tumor stroma, which can act as a physical and immunosuppressive barrier to cancer treatment. The release says VCN-01 has been given to 142 patients to date in clinical trials of different cancers. Those include pancreatic cancer with chemotherapy, head and neck squamous cell carcinoma with an immune checkpoint inhibitor, ovarian cancer with CAR-T cell therapy, colorectal cancer, and retinoblastoma given by intravitreal injection.

Theriva describes itself as a diversified clinical-stage company developing therapeutics for cancer and related diseases. It acquired Theriva Biologics, S.L., formerly VCN Biosciences, S.L., in March 2022. The 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.

## The risks ahead

A poster presents analyses of a completed study, and subgroup findings are not a substitute for a Phase 3 result. The release gives no date for the proposed pivotal trial, and the company has not said how it will fund it. The annual report shows cash from operations of negative $16.7 million in 2025 and negative $16.9 million in 2024. The company says it plans a small study of more frequent VCN-01 dosing. The filings also say a SYN-004 trial depends on funding and that the company is exploring out-licensing or partnering for that asset.

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## Companies in this story

TOVX

Theriva Biologics, Inc.

AMEX · United States

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---
Source page: https://aibio.space/news/theriva-present-virage-trial-biomarker-data-aacr-2026/. Facts in aibio.space stories are checked against company filings and releases; opinion is labelled. Cite as: aibio.space, "Theriva to present VIRAGE trial biomarker data at AACR 2026", 2026-04-17, https://aibio.space/news/theriva-present-virage-trial-biomarker-data-aacr-2026/
