Samsung Bioepis, led by CEO and President Kim Kyung-ah, announced on the 21st that its investigational cancer drug SBE303 has received Fast Track designation from the U.S. Food and Drug Administration (FDA).
SBE303 is an antibody-drug conjugate (ADC) that targets Nectin-4, a protein overexpressed in tumor cells. It is the first novel drug candidate in Samsung Bioepis’ development pipeline.
Nectin-4 is a protein involved in cell-to-cell adhesion and is known to be expressed at higher levels in certain cancer cells, including bladder cancer, than in normal tissue. This characteristic makes it a target protein that can help direct cancer treatments selectively toward tumor cells.
The Fast Track designation applies to the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a Nectin-4-targeted therapy.
The FDA’s Fast Track program is designed to identify investigational drugs with the potential to treat serious conditions for which existing treatments have limitations. Candidates are selected based on evidence supporting their potential, including findings from early studies such as animal testing.
One of the main benefits of Fast Track designation is increased opportunities for direct communication with regulators. As a result, Samsung Bioepis has gained opportunities to strengthen risk management and refine development processes for SBE303 from the early stages of its development.
“The FDA’s Fast Track designation recognizes SBE303’s potential to address unmet medical needs as a treatment for a serious disease,” said Jung Byung-in, head of regulatory affairs at Samsung Bioepis. “It also demonstrates that Samsung Bioepis has research and development capabilities at a global level in novel drug development.”