Theriva Biologics' VCN-01 Receives FDA Fast Track for Metastatic Pancreatic Cancer

ROCKVILLE, Md., May 23, 2024 - Theriva Biologics (NYSE American: TOVX), a clinical-stage company developing innovative treatments for cancer and related diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its lead clinical candidate, VCN-01. This designation applies to the combination of VCN-01 with gemcitabine and nab-paclitaxel for improving progression-free survival and overall survival in patients suffering from metastatic pancreatic adenocarcinoma.

The multinational Phase 2b clinical study, known as VIRAGE, is currently underway, assessing the combination of intravenous VCN-01 with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first-line therapy for pancreatic ductal adenocarcinoma (PDAC) patients. Prior to this, VCN-01 had already received orphan drug designation from the FDA for the treatment of PDAC.

Steven A. Shallcross, Chief Executive Officer of Theriva Biologics, emphasized the significance of the FDA's decision, highlighting the critical need for new treatment options for PDAC, which is the fourth leading cause of cancer-related deaths in the U.S. and Europe. Shallcross noted that the Phase 2b trial is progressing well, with patient enrollment expected to be completed by the third quarter of 2024. He added that the Fast Track Designation would facilitate the expedited review of VCN-01, enabling Theriva Biologics to build on the promising clinical data supporting the therapeutic potential of VCN-01 in combination with chemotherapy or immunotherapy. 

The Fast Track Designation is designed to accelerate the development and review of therapies that show potential for treating serious conditions and fulfilling unmet medical needs. Programs granted FTD benefit from early and frequent interactions with the FDA during the clinical development process, and if specific criteria are met, portions of a marketing application may be reviewed before the complete application is submitted.

Pancreatic Ductal Adenocarcinoma (PDAC) is the most prevalent type of pancreatic cancer, accounting for over 90% of pancreatic tumors. It can be located in the head or the bodytail of the pancreas and often metastasizes to the liver and peritoneum. Due to the lack of early characteristic symptoms, PDAC is typically diagnosed in advanced stages, making surgical resection and curative treatment challenging. Only 10% of cases are resectable at diagnosis, while 30-40% present at an advanced/unresectable stage, and 50-60% with distant metastases.

VCN-01 is an oncolytic adenovirus administered systemically, designed to replicate selectively within tumor cells and degrade the tumor stroma, an immunosuppressive barrier to cancer treatment. This unique mode-of-action allows VCN-01 to exert multiple anti-tumor effects by infecting and lysing tumor cells, enhancing the access of co-administered chemotherapy, and increasing tumor immunogenicity. VCN-01 has been evaluated in over 80 patients in Phase 1 and investigator-sponsored trials for various cancers, including PDAC, head and neck squamous cell carcinoma, ovarian cancer, colorectal cancer, and retinoblastoma.

Theriva Biologics is advancing a new oncolytic adenovirus platform aimed at triggering tumor cell death, enhancing the efficacy of co-administered cancer therapies, and promoting a strong anti-tumor response from the patient's immune system. The company's pipeline includes VCN-01, SYN-004 (ribaxamase), and SYN-020, each targeting different cancer-related conditions.

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