SYN Synthetic Biologics

Theriva™ Biologics Announces Upcoming Presentations at Medical Meetings

Theriva™ Biologics Announces Upcoming Presentations at Medical Meetings

- VCN-01 expanded mPDAC data from VIRAGE Phase 2b trial to be presented at ESMO 2025 -

- SYN-004 Interim blinded safety and pharmacokinetic data to be presented at IDWeek 2025 -

Rockville, Md., Oct. 13, 2025 (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 upcoming presentations at the European Society for Medical Oncology (ESMO 2025) Annual Congress and at Infectious Diseases Week (IDWeek) 2025 Annual Meeting.

VCN-01 upcoming mini-oral presentation at ESMO 2025

Expanded data from the VIRAGE trial investigating VCN-01 (zabilugene almadenorepvec) are to be presented at a mini oral session at the ESMO 2025 Congress:

  • Presenting author: Dr. Rocío Garcia-Carbonero, Hospital 12 de Octubre, Madrid, Spain
  • Title: VIRAGE trial: randomized Phase IIb, open-label, study of Nab-Paclitaxel and Gemcitabine with/without intravenous VCN-01 in Patients with Metastatic Pancreatic Cancer (mPDAC)
  • Abstract #: 2216MO
  • Date and time: Monday, October 20, 2025, 09:28 a.m. CEST
  • Session: Mini oral session 2, GI Tumors Upper digestive
  • Location: Bonn Auditorium - Hall 7.1c, Messe Berlin, Berlin, Germany



SYN-004 upcoming poster presentation at IDWeek 2025

Previously disclosed blinded safety and pharmacokinetic (PK) data from the ongoing Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD). These data will be presented at ID Week 2025:

  • Presenting Author: Erik R. Dubberke, MD, Professor of Medicine, Clinical Director, Transplant Infectious Diseases, Washington University School of Medicine in St. Louis
  • Title: Safety and tolerability of SYN-004 in allogeneic haematopoietic cell transplant (HCT) recipients receiving meropenem (MER) or piperacillin/tazobactam (P/T)
  • Abstract #: P-104
  • Date and time: Monday, October 20, 2025 from 12:15 to 1:30 p.m US EDT
  • Location: Poster Hall B4-5, Georgia World Congress Center, Atlanta, Georgia



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 SYN-004 (ribaxamase)

SYN-004 (ribaxamase) is an oral prophylactic therapy designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of Clostridioides difficile infection (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. Allogeneic HCT recipients routinely receive long courses of IV beta-lactam antibiotics to treat infection following conditioning therapy. Antibiotic-mediated damage of the gut microbiome in allogeneic HCT recipients may lead to adverse outcomes including CDI, VRE colonization and potentially fatal bacteremia and aGVHD. A previously completed placebo-controlled Phase 2b clinical trial of 412 patients demonstrated SYN-004 protected the gut microbiome from antibiotic-mediated dysbiosis. Patients who received SYN-004 also demonstrated significantly better maintenance and recovery of the gut microbiome as well as lower incidences of new colonization by opportunistic and potentially pathogenic microorganisms such as VRE.

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 are: (1) 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; (2) 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; and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics’ website at .

For further information, please contact:

Investor Relations:

Kevin Gardner

LifeSci Advisors, LLC



EN
13/10/2025

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Synthetic Biologics

 PRESS RELEASE

Theriva™ Biologics Licenses SYN-020 to Rasayana Therapeutics for Multi...

Theriva™ Biologics Licenses SYN-020 to Rasayana Therapeutics for Multiple Indications - Theriva received a $300,000 upfront payment at signing and is eligible for up to $38M in development, regulatory, and sales milestones along with tiered single-digit royalties on net product sales - - Rasayana to assume all responsibility and costs for SYN-020 development and commercialization - ROCKVILLE, Md., Feb. 18, 2026 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in ...

 PRESS RELEASE

Theriva™ Biologics Announces Upcoming Presentation of Data from VCN-01...

Theriva™ Biologics Announces Upcoming Presentation of Data from VCN-01 Retinoblastoma Phase 1 Clinical Trial at APAO 2026 - Safety and clinical outcomes of Phase 1 study of VCN-01 (zabilugene almadenorepvec) in refractory retinoblastoma patients to be presented in an invited session at the 41st Asia-Pacific Academy of Ophthalmology (APAO) Congress in Hong Kong on Saturday, 07 February 2026 – - Preclinical data will highlight synergistic antitumor activity for the combination of topotecan and VCN-01 that may improve outcomes in refractory retinoblastoma patients with difficult-to-treat vitr...

 PRESS RELEASE

Theriva™ Biologics Announces Positive Scientific Advice from the Europ...

Theriva™ Biologics Announces Positive Scientific Advice from the European Medicines Agency (EMA) on the Design of a Phase 3 Trial of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) - EMA provided overall agreement with the proposed Phase 3 clinical trial of VCN-01 in combination with gemcitabine/nab-paclitaxel for the first-line treatment of metastatic PDAC, including sample size, repeated dosing of VCN-01, and an adaptive design to potentially optimize trial timelines and outcomes - - Theriva to schedule an End-of-Phase 2 meeting with the FDA in H1 2026 to finalize the design...

 PRESS RELEASE

Theriva™ Biologics Reports Third Quarter 2025 Operational Highlights a...

Theriva™ Biologics Reports Third Quarter 2025 Operational Highlights and Financial Results - Expanded data for VCN-01 (zabilugene almadenorepvec) in metastatic pancreatic ductal adenocarcinoma (PDAC) from the VIRAGE Phase 2b trial presented at the European Society for Medical Oncology (ESMO) Annual Congress 2025 - - Next generation oncolytic virus VCN-12 preclinical data presented at the 32nd Annual Congress European Society of Gene & Cell Therapy (ESGCT) - - Cash and cash equivalents of $7.5 millon as of September 30, 2025; recent capital raises increase cash to $15.5 million as of Novem...

 PRESS RELEASE

Theriva Biologics Provides Response to Unusual Market Action

Theriva Biologics Provides Response to Unusual Market Action ROCKVILLE, Md., Oct. 24, 2025 (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, announced today that the Company had become aware of unusual trading activity in its common stock on the NYSE American (the “NYSE”) on October 24, 2025. The Company is issuing this press release pursuant to Section 401(d) of the NYSE Company Guide. The Company has made inquir...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch