Theriva Biologics Reports that the FDA Granted VCN-01 Fast Track Designation

DENVER, Colo., May 23, 2024 ( Theriva Biologics (NYSE:TOVX) reported that the U.S. Food and Drug Administration (FDA) granted its lead clinical candidate VCN-01 Fast Track Designation (FTD) in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma.

“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,” commented Theriva’s Chief Executive Officer, Steven A. Shallcross. “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.”

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