IASO Bio Secures NMPA Approval to Begin Trials for IASO-782 in Systemic Lupus Erythematosus (SLE)
Friday, July 26, 2024
IASO Biotechnology ("IASO Bio"), a company specializing in advanced cell therapy and antibody products, has received approval from the National Medical Products Administration (NMPA) for its investigational new drug (IND) application for IASO-782 Injection. This fully human monoclonal antibody, targeting human CD19, is now approved for treating systemic lupus erythematosus (SLE), marking a significant expansion of its therapeutic use.
Previously, IASO-782 Injection had secured IND approval in both China and the U.S. for immune thrombocytopenic purpura (ITP) and warm autoimmune hemolytic anemia (wAIHA). The recent approval for SLE highlights IASO Bio's innovative approach and its dedication to addressing a broad range of autoimmune conditions.
IASO Bio emphasized: "Our focus on autoimmune diseases continues with IASO-782 Injection, which has now gained IND approval for three different indications in China and the U.S. Additionally, our CAR T therapy, Equecabtagene Autoleucel Injection, has received NMPA IND approval for neuromyelitis optica spectrum disorder and refractory generalized myasthenia gravis. Cabaletta Bio, our partner, has licensed our CD19 binder to develop CD19-targeting CAR-T therapies for autoimmune diseases, including SLE, with IND approval from the FDA. We are committed to collaborating with industry partners to advance innovative treatments for autoimmune diseases and improve patient outcomes."
Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder involving multiple organs and systems, characterized by alternating periods of flare-ups and remission. It is associated with abnormalities in B lymphocytes and autoimmunity, leading to the production of a wide range of autoantibodies. Without effective treatment, SLE can cause severe and irreversible organ damage. According to Frost & Sullivan, there were around 8.049 million SLE cases worldwide in 2023, with approximately 1.048 million in China. The condition predominantly affects females, with a prevalence ratio of about 1:10-12 compared to males.
IASO-782 Injection is a fully human monoclonal antibody that targets CD19, designed with modifications to enhance antibody-dependent cellular cytotoxicity (ADCC) while maintaining other Fc functions, such as antibody-dependent cellular phagocytosis (ADCP). CD19 is present throughout B cell development and in some plasma cells. IASO-782 effectively reduces CD19+ B cells, plasmablasts, and certain plasma cells, diminishing or eliminating auto-reactive antibodies. As a fully human antibody, IASO-782 is likely to have lower immunogenicity and reduced risk of inducing anti-drug antibodies, making it suitable for long-term treatments of autoimmune diseases.
Source: iasobio.com
