Hangzhou Sumgen Biotech Co., Ltd. (hereinafter referred to as ‘Sumgen Biotech’) has announced today that the phase I clinical study of the proprietary anti-CD47/PD-L1 bispecific antibody SG12473 has been initiated at the Guangdong General Hospital and dosing of the first subject has been successfully completed. This study will recruit patients with solid tumors and hematologic tumors to evaluate the safety, tolerability, PK/PD, and antitumor efficacy of SG12473 monotherapy.
Dr. Lv Ming, CEO of Sumgen, stated that SG12473 is the first bispecific antibody project of Sumgen Biotech that has been approved for clinical trials, and its clinical study has been approved by both the NMPA and FDA at the end of April of this year. The ability to overcome the impact of the COVID pandemic in Guangzhou and the rapid initiation and progression of this project would not have been possible without the strong support of Deans Wu Yilong and Zhou Qing of the Guangdong General Hospital as well as the joint effort of the project team.
SG12473 is a bispecific antibody targeted against both PD-L1 and CD47, which can simultaneously activate T cells by blocking the PD-1/PD-L1 signaling pathway and macrophages by blocking the CD47/SIRPα signaling pathway, thus producing a synergistic antitumor effect. SG12473 has exhibited good antitumor activity in a variety of solid tumors and hematological tumor models in the non-clinical stage.
CD47/SIRPα is one of the most important targets in the field of tumor immunity in the post-PD-1/PD-L1 era. Preliminary clinical studies and a large number of non-clinical studies of CD47-targeting drugs have indicated that anti-CD47 monotherapy or combination therapy with other drugs has potent antitumor activity in hematologic tumors and various solid tumors. However, due to the expression of CD47 on the surface of senescent red blood cells, CD47-targeting antibodies may result in side effects such as severe anemia. During the molecular design of SG12473, the affinity of anti-PD-L1 antibody and CD47 inhibitor is differentiated such that the high affinity of the anti-PD-L1 antibody can "redirect" the product to the tumor, which not only allows the bi-specific antibody to exert synergistic antitumor effects but also reduces its impact on red blood cells.
About the CSG-12473-101 study (Registration no.: CTR20211029)
CSG-12473-101 is a phase I clinical study of SG12473 injection in advanced malignant tumors in China. The objective of the study is to explore the safety, tolerability, and preliminary efficacy of SG12473 monotherapy. This clinical study is led by Guangdong General Hospital and the principal investigator is Professor Zhou Qing.
About Sumgen Biotech
Sumgen Biotech, a biopharmaceutical enterprise currently at the clinical development stage, is devoted to the R&D and commercialization of innovative antibody drugs for major diseases such as cancer. The team of Sumgen has extensive experience in the R&D, industrialization, and international clinical development of new antibody drugs. Sumgen has numerous product pipelines in the field of tumor and several products have been simultaneously approved for clinical trials by the US Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA). Sumgen Biotech is striving to become a world-leading biopharmaceutical enterprise with continuous innovation capabilities and provide effective treatments for cancer patients.
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