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# VCN-01 Orphan Status for Pancreatic Cancer
- URL: https://www.fdaweb.com/vcn-01-orphan-status-for-pancreatic-cancer/
- Published: 2023-06-30T12:00:00.000Z
- Updated: 2026-09-14T18:42:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154807

FDA has granted Theriva Biologics an orphan drug designation for VCN-01, a systemic, selective, stroma-degrading oncolytic adenovirus for treating pancreatic cancer. In the Phase 2b VIRAGE 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. Previously, the agency granted an orphan drug designation to VCN-01 for treating retinoblastoma.

The company says VCN-01 is designed to “selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (**i**) selectively infecting and lysing tumor cells; (**ii**) enhancing the access and perfusion of co-administered chemotherapy products; and (**iii**) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products.”