The drug was developed by Canadian-based Viventia Bio Inc. The company was acquired by Cambridge(MA)-based Eleven Biotherapeutics in 2016, which then changed its name to Sesen Bio.[2]
In 2019 Sesen Bio reported updated, preliminary primary and secondary endpoint data from the company's Phase 3 VISTA trial further supporting the strong benefit-risk profile of Vicineum for the potential treatment of patients with high-risk, bacillus Calmette-Guérin(BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC).[3] The Company applied for approval of Vicineum by the United States Food and Drug Administration and the European Medicines Agency.