On Jan. 19, 2021, CNBG Sumgen Biopharmaceutical (Hangzhou) Co., Ltd. (hereinafter “CNBG Sumgen”) announced the successful completion of dosing in the first patient of the phase I clinical study of its proprietary anti-CD47 injection SG404 in the Peking University Cancer Hospital.
The phase I clinical study is aimed to explore the safety and preliminary efficacy of SG404 in patients with advanced malignancies and to assess the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SG404 alone and SG404 combination regimens in patients with advanced hematologic or solid tumor.
CD47/SIRPα is one of the most important tumor targets in the post-PD-1/PD-L1 era. Blockade of CD47/SIRPα signaling by specific antibodies can restore the phagocytic functions of macrophages, remove the “don’t eat me” signal, and enhance the efficacy of immunotherapy. Preliminary clinical trial results and increasing non-clinical evidence demonstrated that anti-CD47 alone or combination treatments exhibit active antitumor activities in hematologic tumors and various solid tumors.
Lu Qiying, chief medical officer/senior vice president of Sumgen, stated that “SG404 is an important product in the oncology pipelines of Sumgen. SG404 was approved by the NMPA for clinical trial in Nov. 2020, and we were able to complete all clinical preparations within just two months under the support of PIs and researchers at various clinical centers. Today, we have successfully completed the enrollment and dosing of the first patient, which is an important milestone for the SG404 project. Meanwhile, Sumgen has submitted a clinical trial application to the FDA on Jan. 12, 2021, which will serve as a foundation for the launch of China-US joint clinical studies. We have optimized the molecular structure of SG404 and did not observe erythrocyte agglutination in the non-clinical study, which suggests that SGS404 has a differential advantage over other similar products. We are confident in the rapid progression of our clinical study and will strive to provide a better treatment regimen for cancer patients. In addition, Sumgen has already developed a detailed strategic plan for its CD47-based products. Specifically, the CD47/PD-L1 bispecific antibody is currently in the phase of preparation for clinical study. The enrollment of the first patient is expected to be completed in Australia in the first quarter of this year.
SG404
SG404 is a recombinant human SIRPα-Fc fusion protein with optimized affinity. SG404 can specifically bind to CD47 on the surface of tumor cells to effectively block the interaction between CD47 and SIRPα, which in turn removes the immunosuppression of macrophages, activates macrophage-mediated phagocytosis of tumor cells, and thereby exerts tumor immunotherapeutic effects. SG404 is intended for the treatment of various hematologic and solid tumors.
CSG-404-101 study
(Registration number: CTR20202489)
CSG-404-101 study is a phase I clinical study of SG404 for injection in Chinese patients with advanced malignant tumors. This study aims to explore the safety and preliminary efficacy of SG404 alone, and assess the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic characteristics, and preliminary efficacy of SG404 alone and combination therapies in patients with advanced malignant tumors. This study is led by the clinical PIs Shen Lin (director of the department of gastrointestinal tumors) and Song Yuqin (director of the department of lymphoma) at the Peking University Cancer Hospital.
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