Samsung Bioepis Receives FDA Fast Track Designation for SBE303

Samsung Bioepis Co., Ltd. announced today that its antibody-drug conjugate (ADC) candidate, SBE303, has received Fast Track designation from the U.S. Food and Drug Administration (FDA). The designation highlights the urgent medical need for patients with advanced solid tumors and acknowledges the unique approach of targeting Nectin-4 with this next-generation ADC.

Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, stated that this FDA designation establishes a crucial regulatory framework for the program, facilitating increased communication and regular interactions with the agency as the global Phase 1 study progresses. Samsung Bioepis is eager to work closely with the FDA to efficiently guide the clinical development program and advance SBE303 through each stage of evaluation.

The FDA's Fast Track process is designed to expedite the review of investigational medicines for serious or life-threatening conditions, offering opportunities for enhanced engagement with the FDA, eligibility for rolling review, and, if criteria are met, Priority Review and Accelerated Approval. SBE303 is Samsung Bioepis's first novel ADC, engineered to bind to Nectin-4, an adhesion protein expressed specifically in tumor cells, including urothelial cancer, lung cancer, and breast cancer.

Current Nectin-4 targeting ADCs often face limitations in therapeutic index and encounter dose-limiting toxicities. SBE303 addresses these challenges by combining a highly specific anti-Nectin-4 antibody with a potent novel topoisomerase I inhibitor through a proprietary linker. Currently, SBE303 is in Phase I clinical development (NCT07524348).