US FDA Awards Fast Track Designation To Theriva Biologic's VCN-01

The US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. Theriva Biologics is a diversified clinical-stage company that develops therapeutics designed to treat cancer and related diseases in areas of high unmet need. 

“The FDA’s decision to grant FTD to VCN-01 highlights the urgent need for new treatment options for PDAC, which accounts for the 4th highest cause of cancer-associated deaths in the US and Europe,” said Steven A. Shallcross, chief executive officer of Theriva Biologics. “VIRAGE, our phase 2b trial evaluating VCN-01 in metastatic PDAC continues to progress, with enrollment expected to complete in the third quarter of 2024. FTD is an important step that furthers our ability to expedite the review of, and build upon the compelling clinical data that underscores VCN-01’s multiple modes of action and therapeutic potential in combination with chemotherapy or immunotherapy. We will continue to deliver on our mission to advance new therapeutic options for these patients.”

FTD is intended to help medications reach patients more quickly by streamlining the development and review of therapies with the potential to address serious illnesses and meet an unmet medical need. FTD benefits programs by allowing for early and regular engagement with the FDA during the clinical development process. Additionally, if appropriate criteria are met, the FDA may examine elements of a marketing application before the sponsor submits the entire application.