Samsung Bioepis Receives FDA Fast Track Designation for SBE303

Samsung Bioepis headquarters in Incheon. Samsung Bioepis Co., Ltd. today announced that the company’s antibody-drug conjugate (ADC) candidate, SBE303, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). "The FDA’s Fast Track designation for SBE303 reflects the critical unmet medical need in patients with advanced solid tumors and recognizes the therapeutic rationale of targeting Nectin-4 with our next-generation ADC candidate,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “This designation establishes an important regulatory framework for our program, enabling closer dialogue and more frequent interactions with the Agency as our global Phase 1 study advances. We look forward to working collaboratively with the FDA to guide our clinical development program efficiently and advance SBE303 through each stage of evaluation." The FDA’s Fast Track process is designed to facilitate the development and expedite the review of investigational medicines intended to treat serious or life-threatening conditions and address unmet medical needs. The designation provides Samsung Bioepis with opportunities for enhanced engagement with the FDA throughout the clinical development continuum, including more frequent interactions with the agency, eligibility for rolling review, and, if criteria are met, Priority Review and Accelerated Approval, supporting an efficient development and regulatory path. SBE303 is Samsung Bioepis’s first novel ADC engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer.[2] Currently available Nectin-4 targeting ADCs are often limited by narrow therapeutic index and dose-limiting toxicities. SBE303 is engineered to improve the therapeutic window by combining a highly specific anti-Nectin-4 antibody conjugated with a potent novel topoisomerase I inhibitor via a proprietary linker. SBE303 is currently under Phase I clinical development (NCT07524348).