Samsung Bioepis wins FDA Fast Track for 1st anticancer drug candidate

Samsung Bioepis has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for SBE303, an anticancer drug candidate based on antibody-drug conjugate (ADC) technology, the company said Wednesday. SBE303 is the first novel drug candidate in Samsung Bioepis' pipeline. It is an ADC, a type of biopharmaceutical drug designed to deliver powerful cancer-killing agents directly to cancer cells while minimizing damage to healthy tissues. ADCs are oftentimes referred to as "biological missiles" because of their targeted approach. SBE303 targets Nectin-4, a cell adhesion protein expressed in several types of cancer, including urothelial, lung and breast cancers. Existing ADCs targeting Nectin-4 face limitations because of their narrow therapeutic window, meaning the difference between an effective dose and a dose that causes serious side effects is relatively small. Samsung Bioepis designed SBE303 to address these limitations by combining an antibody that specifically targets Nectin-4 with a potent anticancer agent known as a topoisomerase I inhibitor, using its own linker