On February 11, 2021, Hangzhou Sumgen Biotech Co., Ltd. (hereinafter referred to as Sumgen）announced that its self-developed CD47 targeting project SG404 was approved by FDA to preceed the Phase I clinical trial. The purpose of this study is to explore the safety and preliminary efficacy of SG404 alone in patients with advanced malignant tumors, and to evaluate the safety, tolerance, pharmacokinetic characteristics and preliminary effectiveness of SG404 alone and different combination regiments in patients with advanced hematological and solid tumors.
CD47/SIRPα is one of the most important targets in the field of tumor immunotherapy in the post PD-1/PD-L1 era. Blocking CD47/SIRPα signaling pathway with specific antibodies or other drugs can relieve immunosuppression, restore phagocytic activity of macrophages to tumor cells, relieve "don't eat me" signal, and exert strong tumor immunotherapy effect. The preliminary clinical trial results of anti-CD47 drugs and a large number of preclinical evidences 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 antibody drugs will cause severe anemia and other side effects.
SG404 developed by Sumgen is a fusion protein of SIRPα mutant isolated by optimized screening for the purpose of balancing the effectiveness and safety of CD47 antibody drugs. No hemolysis and erythrocyte agglutination were found in preclinical studies, which demonstrated differentiated advantages. SG404 project was approved by NMPA of China in November 2020 to carry out clinical trials, and the first patient in China was administered in January 2021. The clinical research was currently carried out smoothly. Dr. Ming Lv, founder and CEO of Sumgen, stated that: "SG404 was approved by FDA during the clinical study in China, which laid the foundation for the internationalization of this project. The company will take the opportunity to expand clinical research in China and the United States simultaneously".
Sumgen has a deep layout on the signaling pathway of CD47/SIRPa. Except for SG404 project, many innovative bispecific antibodies based on CD47 target are progressing smoothly, and the application for phase I clinical trial of CD47/PD-L1 bispecific antibodies has been accepted by CDE.
SG404
SG404 is a recombinant human SIRP α-Fc fusion protein for injection obtained by affinity optimization. By specifically binding to CD47 on the surface of tumor cells, SG404 can effectively block the interaction between CD47 and SIRP α, relieve the immunosuppression of macrophages, activate the phagocytosis of macrophages on tumor cells, and exert the immunotherapy effect of tumor. SG404 is intended to be used alone or in combination with various therapeutic strategies for the treatment of different hematological tumors and solid tumors.
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