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Theriva™ Biologics to Discuss the Trial Design for VIRAGE - a Phase 2b Clinical Study of Systemically Administered VCN-01 in Combination with Chemotherapy in Pancreatic Ductal Adenocarcinoma - at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

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Theriva™ Biologics (TOVX) announced the acceptance of VIRAGE trial design for a Phase 2b clinical study at the 2024 ASCO Annual Meeting. The study involves VCN-01 in combination with chemotherapy for pancreatic ductal adenocarcinoma.
Theriva™ Biologics (TOVX) ha annunciato l'accettazione del disegno dello studio VIRAGE per uno studio clinico di Fase 2b durante l'incontro annuale ASCO del 2024. Lo studio coinvolge VCN-01 in combinazione con la chemioterapia per il carcinoma duttale del pancreas.
Theriva™ Biologics (TOVX) anunció la aceptación del diseño del ensayo VIRAGE para un estudio clínico de fase 2b en la Reunión Anual de ASCO 2024. El estudio involucra a VCN-01 en combinación con quimioterapia para el adenocarcinoma ductal pancreático.
Theriva™ Biologics (TOVX)는 2024년 ASCO 연례 회의에서 2b상 임상 연구를 위한 VIRAGE 시험 디자인의 승인을 발표했습니다. 이 연구는 췌장의 관상 동맥 암에 대한 화학 요법과 함께 VCN-01을 결합한 것을 다룹니다.
Theriva™ Biologics (TOVX) a annoncé l'acceptation de la conception de l'essai VIRAGE pour une étude clinique de phase 2b lors de la Réunion Annuelle de l'ASCO 2024. L'étude implique VCN-01 en combinaison avec une chimiothérapie pour l'adénocarcinome ductal pancréatique.
Theriva™ Biologics (TOVX) gab die Akzeptanz des Designs der VIRAGE-Studie für eine klinische Studie der Phase 2b auf der ASCO-Jahrestagung 2024 bekannt. Die Studie beinhaltet VCN-01 in Kombination mit Chemotherapie für duktalen Pankreaskarzinom.
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ROCKVILLE, Md., April 25, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that, based on the strength of the science and its relevance, VIRAGE - the Phase 2b randomized, open-label, placebo-controlled, multicenter clinical trial of systemically administered VCN-01 in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) - has been accepted for presentation as a trial-in-progress poster at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL, from May 31-June 4.

ASCO Presentation Details

  • Title: VIRAGE: A Phase IIb, Open-label, Randomized Study of Nab-Paclitaxel and Gemcitabine plus/minus VCN-01 in Patients with Metastatic Pancreatic Cancer
  • Presenter: Dr. Rocío García-Carbonero
  • Session Title: Poster Session – Gastrointestinal Cancer: Gastroesophageal, Pancreatic, and Hepatobiliary
  • Poster Session Date and Time: 01 June 2024, 1:30 PM-4:30 PM US CDT
  • Abstract Number: TPS4210

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 is advancing 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 candidates are: (1) VCN-01, 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 www.therivabio.com.

For further information, please contact:
Investor Relations:
Chris Calabrese
LifeSci Advisors, LLC
ccalabrese@lifesciadvisors.com 
917-680-5608
Source: Theriva Biologics, Inc.


FAQ

What is the purpose of the Phase 2b clinical study VIRAGE by Theriva™ Biologics (TOVX)?

The purpose is to evaluate systemically administered VCN-01 in combination with standard-of-care chemotherapy for newly-diagnosed metastatic pancreatic ductal adenocarcinoma.

When and where will the presentation of VIRAGE trial design take place?

The presentation will be at the 2024 ASCO Annual Meeting in Chicago, IL, from May 31-June 4, 2024.

Who is the presenter of the VIRAGE trial design at the ASCO Annual Meeting?

Dr. Rocío García-Carbonero will be the presenter of the VIRAGE trial design at the ASCO Annual Meeting.

What is the session title for the presentation of the VIRAGE trial design?

The session title is Poster Session – Gastrointestinal Cancer: Gastroesophageal, Pancreatic, and Hepatobiliary.

What is the abstract number for the VIRAGE trial design presentation?

The abstract number is TPS4210.

Theriva Biologics, Inc.

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About TOVX

synthetic biologics, inc. (nyse mkt: syn) is a late-stage clinical company developing therapeutics designed to preserve the microbiome to protect and restore the health of patients. the company's lead candidates poised for phase 3 development are: (1) syn-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (ibs-c), and (2) syn-004 (ribaxamase) which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (iv) beta-lactam antibiotics for the prevention of c. difficile infection (cdi), antibiotic-associated diarrhea (aad) and the emergence of antimicrobial-resistance (amr). the company is also developing preclinical stage monoclonal antibody therapies for the prevention and treatment of pertussis and novel discovery stage biotherapeutics for the treatment of phenylketonuria (pku).