Samsung Bioepis Unveils Preclinical Data on First New Cancer Drug Candidate at AACR 2026

Samsung Bioepis said it has disclosed preclinical data for SBE303, a next-generation antibody-drug conjugate (ADC) cancer drug candidate, for the first time at the American Association for Cancer Research’s AACR 2026 annual meeting, as it moves beyond biosimilars to accelerate development of its own new medicines.

The company said the data were presented at the meeting in San Diego, held April 17-22 (local time).

SBE303 is a next-generation ADC designed to target nectin-4, a protein overexpressed in tumor cells. Samsung Bioepis said it is its first new-drug pipeline developed through joint research and licensing agreements under an open-innovation strategy with domestic and overseas partners Intocell (South Korea) and Frontline (China).

According to preclinical results presented in an on-site poster session on April 20 (local time), SBE303 showed improved tumor-cell binding specificity and more efficient intracellular drug delivery compared with existing nectin-4-targeted therapies, the company said.

In safety assessments, Samsung Bioepis said SBE303 produced improved results in tests for skin toxicity, a common adverse reaction associated with nectin-4-targeted therapies. It also said no interstitial lung disease (ILD), a serious side effect that can cause irreversible damage, was observed.

The company said the highest non-severely toxic dose (HNSTD) was 40 mg/kg, adding that the finding supports the potential for clinical use by securing a wide therapeutic safety margin.

Samsung Bioepis said it has begun global Phase 1 clinical trials of SBE303 in the United States and South Korea. It said it plans to evaluate drug safety and early efficacy in 149 patients with advanced refractory solid tumors from March this year through July 2030.



* This article has been translated by AI.

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