Hangzhou Sumgen Biotech Co., Ltd. (hereinafter referred to as Sumgen) announced today that the Phase I clinical study of its self-developed anti-CD47/PD-L1 bispecific antibody SG12473 was launched in Guangdong Provincial People's Hospital and successfully completed the dosing of first subject. This study will recruit patients with solid tumors and hematological tumors, and evaluate the safety, tolerance, PK/PD and anti-tumor efficacy of monotherapy.
Dr. Lv Ming, Chairman of Sumgen, said that SG12473 was the first bispecific antibody project of Sumgen, which was approved by NMPA and FDA for clinical study at the end of April this year. This project can overcome the influence of COVID-19 pandemic in Guangzhou, start and advance quickly. Special thanks to Dean Wu Yilong, Dean Zhou Qing and leaders at all levels of Guangdong Provincial People's Hospital for their strong support, and thanks to the joint efforts of the project team.
SG12473 is a bispecific antibody targeting PD-L1 and CD47, which can activate T cells by blocking PD-1/PD-L1 signaling pathway and macrophages by blocking CD47/SIRP α signaling pathway, and play a synergistic anti-tumor role. SG12473 exhibits good antitumor activity in preclinical solid tumor and hematological tumor models.
CD47/SIRP α is one of the most important targets in the field of tumor immunology in the post PD-1/PD-L1 era. Preliminary clinical studies and a large number of preclinical studies show that anti-CD47 drugs alone or in combination with other drugs show positive anti-tumor activity in hematological tumors and various solid tumors. However, due to the expression of CD47 molecules on the surface of aging red blood cells, anti-CD47 drugs cause severe anemia and other side effects. In the molecular design process, SG12473 differentiates the affinity between anti-PD-L1 antibody and CD47 inhibitor, in order to "redirect" the bispecific antibodies to the tumor area by means of the high affinity characteristics of anti-PD-L1 antibody, and reduce the influence on red blood cells while exerting synergistic anti-tumor effect.
Study on CSG-12473-101 (registration number: CTR20211029)
CSG-12473-101 is a phase I clinical study of SG12473 for injection in patients with advanced malignant tumors conducted in China. The purpose of this study is to explore the safety, tolerance and preliminary efficacy of SG12473. The lead unit of the clinical research is Guangdong Provincial People's Hospital, and the principle investigators of the project are Dean Wu Yilong and Dean Zhou Qing.
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