Target and Technology
Enfortumab vedotin is an antibody-drug conjugate (ADC) composed of an anti-Nectin-4 monoclonal antibody attached to our synthetic cell-killing agent, monomethyl auristatin E (MMAE), a microtubule-disrupting agent, using our proprietary linker technology. Enfortumab vedotin is the first agent to target Nectin-4, which is expressed on many solid tumors, with especially uniform expression on bladder cancers. Preclinical studies showed that enfortumab vedotin effectively binds to target cells, internalizes and induces cell-killing activity. We are co-developing enfortumab vedotin with Astellas.
In March 2019, Seattle Genetics and Astellas announced positive topline results from the first cohort of patients in the pivotal phase 2 single-arm clinical trial of enfortumab vedotin known as EV-201. In March 2018, we received FDA Breakthrough Therapy Designation based on interim results from the phase 1 study examining enfortumab vedotin as monotherapy treatment for patients with metastatic urothelial cancer who were previously treated with checkpoint inhibitors.
Our ADC technology combines the specificity of monoclonal antibodies, innovative linker systems, and the cell killing power of potent cytotoxic agents to treat cancer. Using our proprietary industry-leading technology, we are able to optimize each ADC to potentially improve outcomes for patients.
See the Pipeline section for information on the ongoing clinical studies evaluating enfortumab vedotin in solid tumors.
Proposed Mechanism of Action
Enfortumab vedotin (ASG-22ME) is an investigational agent, and its safety and efficacy have not yet been established.