Samsung Bioepis said on the 21st that it unveiled preclinical data for the new antibody-drug conjugate (ADC) SBE303 for the first time at the American Association for Cancer Research (AACR 2026) annual meeting in San Diego.
SBE303 is a next-generation ADC anticancer drug candidate that targets nectin-4, a protein overexpressed in tumor cells. It is the first new drug pipeline (candidate) that Samsung Bioepis is developing through joint research and license agreements with Korea-based IntoCell and China-based Frontline under its open innovation strategy.
According to the preclinical results the company presented during an on-site poster session on the 20th (local time), SBE303 showed improved antibody binding specificity to tumor cells and enhanced intracellular drug delivery efficiency compared with existing nectin-4–targeted therapies.
In particular, in the safety assessment, it showed improved results in skin toxicity tests, a common adverse reaction with existing nectin-4–targeted therapies. Interstitial lung disease (ILD), which causes irreversible damage as a serious side effect, was also not observed.
The highest non-severely toxic dose (HNSTD), the maximum dose at which no in vivo toxic response is observed, was 40 mg/kg, confirming the potential for clinical application of SBE303 through securing a wide therapeutic index.
Shin Dong-hoon, head of clinical medicine and executive vice president at Samsung Bioepis, said, "With these study results, we once again confirmed our antibody drug development capabilities, and through subsequent clinical studies of SBE303, we plan to continue verifying the potential to meet diverse unmet medical needs by developing a next-generation ADC anticancer therapy with efficacy and safety."
Samsung Bioepis has begun global phase 1 clinical trials of SBE303 in the United States, Korea, and elsewhere, and from Mar. this year through Jul. 2030, it plans to evaluate drug safety and initial efficacy in 149 patients with advanced refractory solid tumors.
Meanwhile, after a spin-off from Samsung Biologics, which operates a CDMO business, Samsung Bioepis was incorporated as a subsidiary of the newly established biotech investment holding company Samsung Epis Holdings last year.