Hangzhou Sumgen Biotech Co., Ltd. (hereinafter referred to as Sumgen) announced today that its self-developed Chinese clinical study of anti-CD38 monoclonal antibody SG301 injection successfully completed the first subject medication in Chaoyang Hospital affiliated to Capital Medical University. This study will recruit patients with malignant hematological tumors and evaluate their safety, tolerance, PK/PD and anti-tumor efficacy.
CD38 is a single-stranded transmembrane type II glycoprotein, which is normally expressed in plasma cells, natural killer cells, monocytes and other immune cells. CD38 is highly expressed in multiple myeloma, lymphoma, leukemia and other malignant hematological tumors. Monoclonal antibodies targeting CD38 have been clinically verified and approved for marketing in the treatment of multiple myeloma and other diseases.
SG301 is a humanized anti-CD38 monoclonal antibody with unique epitope, specifically binds to CD38 on tumor cells, and exerts anti-tumor effects through antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cell phagocytosis (ADCP), Fc receptor-mediated Cross-linking-induced apoptosis and inhibition of CD38 cyclase activity. SG301 showed good anti-tumor activity in various preclinical hematological tumor models. Compared with the marketed antibody drugs with the same target, SG301 shows stronger anti-tumor activity at both in vitro and in vivo levels. SG301 was first approved by FDA in October 2020 to start clinical study.
Study on CSG-301-101
CSG-301-101 study (registration number: CTR20211029) is clinical study on recombinant humanized anti-CD38 monoclonal antibody injection (SG301 injection) in patients with malignant hematological tumors conducted in China. The purpose of this study is to explore the safety, tolerance and preliminary efficacy of SG301. The lead unit of this clinical research is Chaoyang Hospital affiliated to Capital Medical University, and the principle investigator is Professor Chen Wenming.
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