Target and Technology
Enfortumab vedotin (ASG-22ME) 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 data demonstrate that enfortumab vedotin effectively binds to target cells, internalizes and induces cell-killing activity. We are co-developing enfortumab vedotin with Astellas.
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.
Clinical Development Status
- EV-201: Pivotal phase 2 trial of single-agent enfortumab vedotin for metastatic urothelial cancer patients who have been previously treated with a checkpoint inhibitor therapy. This includes patients who have not received platinum-containing regimens for their locally advanced or metastatic disease, and are ineligible for treatment with cisplatin.
- EV-103: Phase 1b trial of enfortumab vedotin in combination with checkpoint inhibitor therapies in patients with metastatic urothelial cancer (bladder cancer)
Proposed Mechanism of Action
Enfortumab vedotin (ASG-22ME) is an investigational agent, and its safety and efficacy have not yet been established.