Hangzhou Sumgen Biotech Co., Ltd. (hereinafter referred to as "Sumgen Biotech") announced today that the phase I clinical study of its self-developed first-in-class anti-CD38/CD47 bispecific antibody SG2501 successfully completed the dosing of first subject in the U.S.
Dr. Ming Lv, Chairman of Sumgen Biotech, said: "CSG-2501-101 is the company's first clinical study conducted in the United States. The successful initiation of this study and the completion of dosing for the first patient lay the foundation for the internationalization of our innovative product pipeline, marking another significant milestone in the company's development."
SG2501 is the world's first anti-CD38/CD47 bispecific antibody developed based on Sumgen Biotech BIMA bispecific antibody platform. It can specifically bind CD38/CD47 molecules at the same time. On the one hand, it mediates antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell phagocytosis (ADCP) and inhibits CD38 cyclase activity through the CD38 end. On the other hand, it blocks the CD47/SIRPα immune inhibitory pathway and activates macrophage activity through its CD47 end, exerting a synergistic anti-tumor effect. Preclinical studies show that SG2501 has a clear anti-tumor effect and controllable safety profile.
About the CSG-2501-101 study
CSG-2501-101 (NCT05293912) is a phase I clinical study of SG2501 in patients with relapsed or refractory malignant hematologic tumors conducted in the U.S. The purpose of this study is to explore the safety, tolerability and preliminary efficacy of SG2501 monotherapy.
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