Vicinium™ is Viventia Biotechnologies Inc. (“Viventia”) mAb product candidate for the treatment of non-muscle invasive transitional cell carcinoma (TCC) of the bladder, the second most common malignancy of the genitourinary system.  Vicinium™ is based upon Viventia’s Armed Antibody™ technology, containing the active pharmaceutical ingredient (API) VB4-845, a recombinant fusion protein produced in Escherichia coli (E. coli). The tumor-targeting component of VB4-845 comprises a humanized, single-chain antibody fragment specific for the EpCAM antigen. The antibody fragment is recombinantly fused to a truncated form of Pseudomonas exotoxin A, ETA_(252-608), engineered to lack the cell binding domain, but to retain the active domains necessary to induce cell death.

Vicinium™ has been evaluated in several preclinical studies, an exploratory Phase I/II clinical trial, and a Phase II trial to assess safety, tolerability and efficacy. A dose dependent relationship was established, with patients in the high dose group achieving the highest overall response rate. Efficacy and safety results demonstrate that:

• Vicinium™ is effective in a BCG refractory patient population with Carcinoma in Situ (CIS)
• Vicinium™ is safe and very well tolerated
• Vicinium warrants further development not only for refractory patients with CIS but also for the early treatment of all stages of TCC