Theriva Biologics Receives FDA Guidance on Phase 3 Study Design for VCN-01 in Pancreatic Cancer Treatment

Theriva Biologics, Inc. recently disclosed the outcomes of a Type D meeting with the U.S. Food and Drug Administration (FDA), outlining details regarding the design of a Phase 3 clinical study involving lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy to address metastatic pancreatic adenocarcinoma (PDAC). The announcement follows the completion of the target enrollment into the multinational VIRAGE Phase 2b clinical study evaluating intravenous VCN-01 paired with gemcitabine/nab-paclitaxel as a first-line therapy for PDAC patients on December 5, 2024.

Type D meetings such as this focus on specific issues critical to decision-making points in drug development programs, providing crucial feedback for progression. The FDA advised against expanding the ongoing VIRAGE Phase 2b study into a Phase 3 study. Instead, the optimal approach for the VCN-01 PDAC program involves conducting a stand-alone Phase 3 study of VCN-01 with gemcitabine/nab-paclitaxel. The FDA supported the company’s proposed Phase 3 study design, emphasizing that additional standard-of-care chemotherapy for PDAC was unnecessary as it could complicate the study and analysis process. The FDA also outlined preferences regarding statistical elements in confirmatory clinical studies, including methods for sample size estimation and the study population(s) for data analysis.

It is important to note that the information disclosed in the press release and Form 8-K shall not be considered filed for purposes of the Securities Exchange Act of 1934 or incorporated into any future filings with the U.S. Securities and Exchange Commission by the company.

In a statement by Theriva Biologics’ Chief Executive Officer, Steven A. Shallcross, he highlighted the significance of the FDA’s guidance on elements for a potential confirmatory Phase 3 study, emphasizing the importance of this information as they plan for the next steps in the development of VCN-01.

A follow-up meeting with the FDA will be requested after the VIRAGE study’s completion to further discuss the details of the proposed Phase 3 study protocol for VCN-01.

VCN-01 is an oncolytic adenovirus aimed at selectively replicating in tumor cells and breaking down tumor stroma, which acts as a physical and immunosuppressive barrier to cancer treatment. The company’s approach encompasses triggering tumor cell death, enhancing access to co-administered therapies, and prompting a robust anti-tumor response by the patient’s immune system, affecting both primary tumors and metastases.

Theriva Biologics (NYSE American: TOVX) is a clinical-stage company focused on developing therapeutics for cancer and related diseases. The company is advancing an oncolytic adenovirus platform designed for intravenous, intravitreal, and antitumoral delivery to address tumor cell death and improve the patient’s immune response against tumors.

This press release contains forward-looking statements that are subject to various risks and uncertainties. Theriva Biologics undertakes no obligation to update such statements conveyed in this release, except as required by law.

For more information, please contact Investor Relations at LifeSci Advisors, LLC.

Source: Theriva Biologics, Inc.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Synthetic Biologics’s 8K filing here.

About Synthetic Biologics

Synthetic Biologics, Inc, a clinical-stage company, develops therapeutics to treat diseases in areas of high unmet need. The company's lead product candidates include SYN-004 designed to degrade various commonly used intravenous beta-lactam antibiotics in gastrointestinal (GI) tract for the prevention of microbiome damage, clostridium 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 recipients; and SYN-020, a recombinant oral formulation for the enzyme intestinal alkaline phosphatase to treat both local GI and systemic diseases.