Eleven Biotherapeutics

Vicinium™ (VB4-845):
Recombinant fusion protein in clinical development for the treatment of high-grade non-muscle invasive bladder cancer

Vicinium is Eleven’s Phase 3 product candidate based on the company’s Targeted Protein Therapeutics (TPT) platform. Vicinium consists of a single chain anti-EpCAM (epithelial cell adhesion molecule) antibody fragment fused with a potent cytotoxin, designed to be an optimized therapeutic for local tumor administration (via intratumoral injection) for the treatment of non-muscle invasive bladder cancer (NMIBC).

The pivotal Phase 3 trial of Vicinium is ongoing, and topline data is expected in 2018. To date, Vicinium has been evaluated in over 100 subjects. In a Phase 2 clinical trial, Vicinium demonstrated a complete response (CR) rate of 40% at 3 months , with no drug-related serious adverse events (SAEs) observed in the trial.

Vicinium is designed to avoid healthy cells and specifically target cancer cells expressing EpCAM, which internalize the TPT once it is bound. Within the cell, the payload dissociates from the single chain antibody fragment and is then able to exert its cell-killing activity.

Vicinium's Mechanism of Action

Bladder cancer is a disease with unmet need, and Vicinium™ represents a new approach to treating bladder cancer. The VISTA clinical study is evaluating Vicinium for the treatment of high-grade non-muscle invasive bladder cancer. For more information on bladder cancer research and the VISTA clinical study, please visit www.mybladdercancer.com.