Sumgen Announces FDA Clearance of IND Application for SG2501, First-in-class CD47/CD38 Bispecific Antibody

date:2021-11-22      source:

Hangzhou Sumgen Biotech Co., Ltd. (hereinafter referred to as Sumgen) recently announced that the world's first anti-CD38/CD47 bispecific antibody SG2501 developed by Sumgen has been approved by FDA for clinical study.

About 2501 bispecific antibody

SG2501 is the world's first anti-CD38/CD47 bispecific antibody developed based on Sumgen BIMA bispecific antibody platform. It can specifically bind CD38/CD47 molecules at the same time, mediate antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cell phagocytosis (ADCP), inhibit CD38 cyclase activity, and exert synergistic anti-tumor effect. Preclinical studies show that SG2501 has clear anti-tumor effect and controllable safety. The clinical approval of SG2501 by FDA is an important milestone in the gradual internationalization of the company. The clinical preparations for this project in the United States are progressing steadily, and clinical enrollment will be started in the near future.

BIMA platform is a macrophage-associated bispecific antibody platform developed by the company. In the early stage, based on computer-aided design and mammalian cell display technology, the company screened and obtained a series of SIRPa mutants with different biological activities, which can meet the requirements of bispecific antibody development involving various tumor-related antigens and optimize the activity of bispecific antibodies. As an important part of the company's dual-target antibody development platform, based on BIMA platform, the company has laid out a number of "1+1 > 2" bispecific antibody projects, of which 2 have been approved for clinical study, and many projects are in the preclinical research stage.

CD38 target

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.

CD47 target

CD47/SIRP α is one of the most important targets in the field of tumor immunity in the post PD-1/PD-L1 era. Blocking CD47/SIRP α signaling pathway with specific antibodies and 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. More than 30 drugs have been developed in clinical stage for CD47-SIRP α pathway in the world, and positive progress has been made in combination with various tumor treatment strategies.

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