Samsung Bioepis wins FDA Fast Track for 1st anticancer drug candidate
Samsung Bioepis office in Incheon / Courtesy of Samsung Bioepis
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 technology. SBE303 is currently undergoing Phase 1 clinical development.
The FDA's Fast Track program is designed to expedite the development and review of drugs that show potential to treat serious diseases for which existing treatments are inadequate.
The designation allows Samsung Bioepis to engage more frequently with the FDA throughout the clinical development process. SBE303 may also qualify for rolling review, priority review and accelerated approval if the relevant criteria are met.
"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,” Samsung Bioepis Vice President Jung Byoung-in said.
“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."