IASO Bio Announces NMPA IND Clearance for Fully Human Anti-CD19 Monoclonal Antibody IASO-782 for Systemic Lupus Erythematosus
IASO Biotechnology
Cancer Treatment New Drug Developer
July 25, 2024, Nanjing, Shanghai, China, and San Jose, California, USA — IASO Bio, a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative cell therapies, announcedThe IND application for IASO-782 Injection, a fully human anti-CD19 monoclonal antibody independently developed by the company, has received tacit approval from the National Medical Products Administration (NMPA) for the proposed treatment of Systemic Lupus Erythematosus (SLE).。
Previously, the IASO-782 injection had received IND approval in both China and the U.S. for indications including Immune Thrombocytopenia (ITP) and Warm Antibody Autoimmune Hemolytic Anemia (wAIHA). The recent approval for the SLE indication further expands the therapeutic scope of the IASO-782 injection, once again demonstrating IASO Bio's innovative strength in the biopharmaceutical field and deep understanding of patient needs.
Dr. Jie Chen, Chief Medical Officer of IASO BioIndicates:"The field of autoimmune diseases is a key focus of IASO Bio's strategic development. Since last year, IASO-782 injection has successfully obtained three IND approvals in both China and the United States."In addition, the clinical trial application for IASO Bio's CAR-T cell product, Equecabtagene Autoleucel Injection, to treat neuromyelitis optica spectrum disorders and refractory generalized myasthenia gravis, has also received tacit approval from the National Medical Products Administration.In addition, our partner Cabaletta Bio has developed a CAR-T cell therapy using the CD19 sequence licensed from us to treat autoimmune diseases and has received IND approval from the U.S. Food and Drug Administration for four autoimmune diseases, including systemic lupus erythematosus.IASO Bio will continue to collaborate with industry peers to further drive innovation and progress in the treatment of autoimmune diseases, bringing significant clinical benefits to patients through innovative therapies.”
About Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disease and one of the earliest human diseases discovered to be associated with abnormal subsets of B lymphocytes. Its primary clinical features include involvement of multiple systems and organs, an unpredictable course characterized by alternating periods of flare-ups and remission, and the presence of numerous autoantibodies in the body. Without timely treatment, irreversible damage to affected organs may occur, ultimately leading to patient death. According to a Frost & Sullivan report, there were approximately 8.049 million SLE patients globally in 2023, of which about 1.048 million were in China. The male-to-female ratio of affected individuals is 1:10~12.[1]。
About IASO-782 Injection
IASO-782 is a fully human monoclonal antibody targeting CD19, with Fc mutations to enhance antibody-dependent cell-mediated cytotoxicity while maintaining other Fc functions (such as antibody-dependent cell-mediated phagocytosis). The B-cell surface antigen CD19 is expressed during B-cell development, from pre-B cells through plasmablasts and some plasma cells. Many autoimmune diseases, such as ITP and wAIHA, are primarily mediated by pathogenic B cells and plasma cells producing autoreactive antibodies. IASO-782 can effectively deplete CD19-positive B cells, plasmablasts, and some plasma cells in the human body, thereby reducing or eliminating autoreactive antibodies produced by these cells. IASO-782 has the potential to treat a range of autoimmune diseases associated with autoreactive antibodies. Additionally, as a fully human antibody, IASO-782 has low immunogenicity and is less likely to induce anti-drug antibodies with repeated dosing, offering potential advantages for treating autoimmune conditions that require long-term, repeated administration.
