Samsung Bioepis Unveils Preclinical Results for Its First New Drug at U.S. Cancer Research Association

Samsung Bioepis announced on April 21 that it has released research data on its antibody-drug conjugate (ADC) new drug "SBE303" for the first time at the American Association for Cancer Research (AACR 2026) Annual Meeting, held in San Diego, United States, from April 17 to 22.

SBE303 is a next-generation ADC anticancer drug targeting the Nectin-4 protein, which is overexpressed in tumor cells. This is the first new drug pipeline developed by Samsung Bioepis through joint research and license agreements with domestic and international partners, including IntoCell and Frontline, as part of its open innovation strategy.

A representative from Samsung Bioepis is participating in a U.S. conference to explain the preclinical research results of the antibody-drug conjugate (ADC) new drug "SBE303." Samsung Bioepis

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According to preclinical results unveiled by Samsung Bioepis during an on-site poster presentation session on April 20 local time, SBE303 demonstrated improved tumor cell binding specificity of the antibody and more efficient intracellular drug delivery compared to existing Nectin-4 targeted therapies.

Notably, in the safety assessment, SBE303 showed improved results in skin toxicity tests, which are common adverse reactions with existing Nectin-4 targeted therapies. In addition, no cases of interstitial lung disease (ILD), a severe side effect that can cause irreversible damage, were observed.

Furthermore, the "Highest Non-Severely Toxic Dose (HNSTD)"-the maximum dose at which no in vivo toxic reactions were observed-was found to be 40 mg/kg, confirming the potential for clinical application of SBE303 through a wide therapeutic index.

Donghoon Shin, Executive Vice President and Head of Clinical Medicine at Samsung Bioepis, stated, "These research results once again demonstrate our capacity to develop antibody drugs. Through subsequent clinical studies of SBE303, we will continue to verify the potential of developing next-generation ADC anticancer drugs with both efficacy and safety, addressing various unmet medical needs."

Meanwhile, Samsung Bioepis has begun Phase 1 global clinical trials of SBE303 in the United States, Korea, and other countries. From March 2026 to July 2030, the company plans to evaluate drug safety and initial efficacy in 149 patients with progressive, refractory solid tumors.

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