Samsung Bioepis said it has disclosed preclinical data for its next-generation antibody-drug conjugate, or ADC, cancer drug candidate SBE303 for the first time at the American Association for Cancer Research annual meeting, AACR 2026, as it moves beyond biosimilars toward developing its own new medicines.
The company said it presented the data at the meeting being held April 17-22 (local time) in San Diego.
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 partner companies Intocell in South Korea and Frontline in China.
According to the preclinical results presented in an on-site poster session on April 20 (local time), SBE303 showed improved antibody binding specificity to tumor cells and more efficient intracellular drug delivery compared with existing nectin-4-targeted therapies.
In safety assessments, the company said SBE303 showed improved results in tests for skin toxicity, a common adverse reaction associated with existing nectin-4-targeted therapies. It also said no interstitial lung disease, or ILD, which can cause irreversible damage as a serious side effect, was observed.
Samsung Bioepis said the highest non-severely toxic dose, or HNSTD, was 40 mg/kg. The company said the finding suggests 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, South Korea and other countries. 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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