Background:Enfortumab vedotin is an antibody-drug conjugate ADC designed for the treatment of cancer expressing Nectin-4. It was developed through two main lines, hybridoma ASG-22ME and Chinese hamster ovary ASG-22CE. Enfortumab refers to the fully humanized from mouse monoclonal antibody mAb created by scientists at Agensys part of Astellas using Amgen’s transgenic system XenoMouse, it is the first agent to target Nectin-4 that expressed on many solid tumors especially on bladder cancers. Vedotin refers to the payload drug microtubule-disrupting agent monomethyl auristatin E MMAE and the linker. The linker technology holding the antibody and the toxin together was provided by and licensed from Seattle Genetics. Preclinical studies showed that enfortumab vedotin effectively binds to target cells, internalizes and induces cell-killing activity. Mouse and patient xenograft models were used to test enfortumab vedotin’s antitumor activity in human breast, bladder, pancreatic and lung cancers. In March 2018, Seattle Genetics and Astellas received the U.S. Food and Drug Administration FDA Breakthrough Therapy Designation for enfortumab vedotin 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.
Alternative Names:AGS-22CE, AGS-22M, AGS-22M6E, unconjugated : AGS-22C3 or AGSM6,