Theriva™ Biologics Announces Upcoming Presentation of Additional Data from the VIRAGE Phase 2b Clinical Trial of VCN-01 in Metastatic Pancreatic Cancer at AACR 2026 Annual Meeting
Rhea-AI Summary
Theriva Biologics (NYSE American: TOVX) will present additional tumor response, biomarker, and subgroup analyses from the VIRAGE Phase 2b trial of VCN-01 plus gemcitabine/nab-paclitaxel at AACR 2026 in San Diego on April 20, 2026.
The poster (CT162) by Dr. Manuel Hidalgo reports data supporting an immune-mediated mode of action and improved outcomes across multiple subgroups, including patients with liver metastases. The company says it has alignment with the FDA and EMA on a proposed pivotal Phase 3 and plans a small dosing study to test more frequent/extended VCN-01 dosing.
AI-generated analysis. Not financial advice.
Positive
- Phase 2b data support immune-mediated mode of action
- Improved outcomes observed in VCN-01 treated patients, including liver metastases
- Alignment with FDA and EMA on proposed pivotal Phase 3
- Planned small study to test more frequent and extended VCN-01 dosing
Negative
- Open-label Phase 2b design may limit blinded efficacy assessment
- Proposed pivotal Phase 3 is aligned but not yet initiated
News Market Reaction – TOVX
On the day this news was published, TOVX gained 59.41%, reflecting a significant positive market reaction. Argus tracked a peak move of +67.9% during that session. Our momentum scanner triggered 53 alerts that day, indicating high trading interest and price volatility. This price movement added approximately $4M to the company's valuation, bringing the market cap to $11.80M at that time. Trading volume was above average at 1.7x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Peer moves appear mixed. The momentum scanner only flagged AZTR with a +1.8% move and no related news, while no other close peers were in momentum and sector headlines were absent.
Previous Conferences,clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 03 | Conference trial update | Positive | +3.4% | Phase 1 VCN-01 retinoblastoma outcomes and safety at APAO 2026. |
| Apr 22 | Conference preclinical data | Positive | -8.3% | Preclinical data on VCN-01 synergy with first-line pancreatic chemo at ASGCT. |
Conference/clinical data presentations for VCN-01 have produced mixed single-digit reactions, with one positive and one negative move.
Over recent conference and clinical data events, Theriva has repeatedly highlighted VCN-01 across solid tumor indications. On Feb 03, 2026, the company announced an invited APAO 2026 presentation of Phase 1 data in refractory retinoblastoma, which was followed by a +3.37% move. Earlier, on Apr 22, 2024, preclinical synergy data for VCN-01 with first-line pancreatic chemotherapy at ASGCT coincided with a -8.3% reaction. Today’s AACR Phase 2b VIRAGE update fits this ongoing data-disclosure cadence.
Historical Comparison
In the past, similar conferences/clinical data releases for VCN-01 led to an average move of -2.47%. Today’s -1.1% reaction to additional VIRAGE Phase 2b data sits within that historical range for this tag.
Historical same-tag events trace VCN-01 from preclinical synergy data in pancreatic cancer to Phase 1 outcomes in retinoblastoma, with the current AACR poster adding deeper Phase 2b biomarker and subgroup insights in metastatic pancreatic cancer.
Regulatory & Risk Context
An effective Form S-3 filed on Nov 07, 2025 covers resale of up to 16,184,560 shares issuable from New Warrants. Theriva is not offering primary shares under this prospectus and receives cash only upon warrant exercise; selling stockholders receive any resale proceeds.
Market Pulse Summary
The stock surged +59.4% in the session following this news. A strong positive reaction aligns with the company’s pattern of using conferences to showcase VCN-01 progress in pancreatic cancer and other tumors. Prior same-tag events produced both gains and losses around -2.47% on average, so a large upside move would have stood out versus history. Investors would have weighed the new biomarker and subgroup data against existing regulatory feedback and the pathway toward the planned Phase 3 trial.
Key Terms
phase 2b medical
phase 3 medical
biomarker medical
metastatic pancreatic cancer medical
immune-mediated medical
mode of action medical
gemcitabine medical
nab-paclitaxel medical
AI-generated analysis. Not financial advice.
- Tumor reponse, biomarker, and subgroup analyses from the VIRAGE Phase 2b clinical trial support a VCN-01 immune-mediated mode of action and demonstrate improved outcomes in VCN-01 treated patients across multiple subgroups, including patients with liver metastases -
- Data to be presented in a poster session at the American Association of Cancer Research (AACR) Annual Meeting in San Diego, California on Monday April 20, 2026-
ROCKVILLE, Md., April 17, 2026 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced an upcoming poster presentation of new data and subgroup analyses from the VIRAGE Phase 2b clinical trial evaluating VCN-01 (zabilugene almadenorepvec) plus gemcitabine/nab-paclitaxel in newly-diagnosed metastatic pancreatic cancer patients. Tumor reponse, biomarker data, and subgroup analyses are to be presented at the American Association for Cancer Research (AACR) Annual Meeting to be held in San Diego, CA from 17-22 April 2026.
Details of the poster presentation are below:
- Presenting author: Dr. Manuel Hidalgo, NYU Langone Health Perlmutter Cancer Center, New York, NY
- 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 US PDT
- Session: PO.CT01.05 - Phase II and Phase III Clinical Trials
- Location: San Diego Convention Center, Hall B, Section 52, Board 26.
“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. “Taken together, the tumor response and biomarker data support an immune-mediated mode of action for VCN-01, which is consistent with the previously reported clinical observations, showing that patients treated with VCN-01 plus gemcitabine/nab-paclitaxel experienced a significantly protracted duration of response concomitant with a later-stage prolongation of survival compared to patients treated with gemcitabine/nab-paclitaxel alone. We have achieved alignment with both the FDA and the EMA on a proposed pivotal Phase 3 clinical trial to evaluate multiple doses of VCN-01 plus gemcitabine/nab-paclitaxel in first-line metastatic PDAC patients, and we are planning a small study to assess whether more frequent and extended VCN-01 dosing could further improve outcomes.”
About Pancreatic Ductal Adenocarcinoma
Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma (“PDAC”) accounts for more than
About VCN-01
VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in clinical trials of different cancers, including pancreatic ductal adenocarcinoma (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.
About Theriva™ Biologics, Inc.
Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s subsidiary Theriva Biologics, S.L. , has been developing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage candidates is VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment. An exploratory clinical trial is also on-going with SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. For more information, please visit Theriva™ Biologics’ website at www.therivabio.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements regarding the Company’s confidence in the clinical potential of VCN-01 plus gemcitabine/nab-paclitaxel chemotherapy to help metastatic PDAC patients; tumor response and biomarker data supporting an immune-mediated mode of action for VCN-01; alignment with the FDA and EMA on a proposed Phase 3 clinical trial evaluating multiple doses of VCN-01 plus gemcitabine/nab-paclitaxel in first-line metastatic PDAC patients; and planning a small study to assess whether more frequent and extended VCN-01 dosing could further improve outcomes. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to finalize the proposed pivotal Phase 3 study protocol and file a BLA; the Company’s ability to obtain development funding and/or partnerships; the Company’s ability to reach clinical milestones when anticipated, including the ability to continue to enroll patients as planned; generating clinical data that establishes VCN-01 may improve patient outcomes in metastatic PDAC patients; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, including approval of VCN-01 to treat patients with PDAC; regulatory limitations relating to the Company’s ability to promote or commercialize their product candidates for the specific indications; acceptance of the Company’s product candidates in the marketplace; the successful development, marketing or sale of the Company’s products; developments by competitors that render such products obsolete or non-competitive; the Company’s ability to maintain license agreements; the continued maintenance and growth of the Company’s patent estate; the ability to continue to remain well financed; and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
For further information, please contact:
Investor Relations:
Kevin Gardner
LifeSci Advisors, LLC
kgardner@lifesciadvisors.com
