Ÿ   Under the agreement, Samsung Bioepis will obtain exclusive commercial licensing rights to SBE303, an ADC candidate currently in joint development

Ÿ   This agreement marks the first commercial license agreement to be signed between the two parties under the collaboration to jointly develop up to five ADC candidates

Ÿ   IntoCell has been providing its proprietary linker-payload technology to Samsung Bioepis for the evaluation and validation of ADC candidates

Samsung Bioepis Co., Ltd. announced that it has entered into a commercial license agreement with IntoCell, Inc. for SBE303, one of the antibody-drug conjugate (ADC) candidates that the two companies are jointly developing. Samsung Bioepis has been collaborating with IntoCell since December 2023 when the companies entered into a research collaboration agreement to apply IntoCell’s proprietary linker-payload technology for the development of up to five ADC candidates.

Under the agreement, Samsung Bioepis will obtain exclusive commercial rights to SBE303, Samsung Bioepis’ first novel ADC candidate engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer. The financial terms of the agreement remain confidential.

“This agreement marks an important milestone in the continued expansion of our pipeline beyond biosimilars,” said Kyung-Ah Kim, President and Chief Executive Officer, Samsung Bioepis. “By securing the commercial rights to this promising ADC candidate, we are strengthening our presence in the rapidly evolving oncology landscape while advancing our commitment to bringing innovative treatment options to patients worldwide. We look forward to realizing the commercial potential of this program together.”

The Nectin-4 targeting ADCs available today are often limited by narrow therapeutic index (TI) and dose-limiting toxicities. SBE303 is engineered to improve the therapeutic window by combining a highly specific anti-Nectin-4 antibody conjugated with a potent novel topoisomerase I inhibitor. SBE303 is currently in Phase 1 clinical trial in an open‑label, multi-center, first‑in‑human trial to evaluate the safety, tolerability and efficacy of SBE303 in participants with advanced refractory solid tumors (NCT07524348).