Theriva Biologics's VCN-01 Secures FDA's Oprhan Drug Designation

(RTTNews) - Theriva Biologics (TOVX), a clinical-stage company developing therapeutics designed to treat cancer and related diseases, Tuesday announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to lead clinical candidate VCN-01 for the treatment of pancreatic cancer.

In the ongoing multinational Phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with pancreatic ductal adenocarcinoma (PDAC).

Previously, the FDA granted orphan drug designation to VCN-01 for treatment of retinoblastoma.

"The FDA's decision to grant orphan drug designation to VCN-01 highlights the urgent need for new treatment options for patients with PDAC, which has one of the lowest survival rates among all cancers," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics.