BRIEF—Theriva gets FDA Rare Pediatric Drug designation for VCN-01

US clinical-stage caner drug developer Theriva Biologics revealed that the US Food and Drug Administration (FDA) has granted Rare Pediatric Drug designation (RPDD) for VCN-01 for the treatment of retinoblastoma.

VCN-01, Theriva’s lead product candidate, is a systemic, selective, stroma-degrading oncolytic adenovirus. Previously, the FDA granted orphan drug designation to VCN-01 for treatment of retinoblastoma, a rare malignant tumor of the retina affecting young children.

“The FDA’s decision to grant rare pediatric drug designation to VCN-01 highlights the urgent need for new treatment options for pediatric patients with retinoblastoma,” said Steven Shallcross, chief executive of Theriva Biologics.