FDA Approves IASO Bio's IND Application for IASO-782 as a Treatment for Autoimmune Disease
Saturday, June 17, 2023
IASO Bio, a clinical-stage biopharmaceutical company specializing in cell therapies and antibody products, has received FDA approval for its Investigational New Drug (IND) application for IASO-782 Injection. This approval allows the company to conduct clinical trials in the United States for the treatment of autoimmune hematological disorders, including primary immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA).
The IND approval for IASO-782 Injection is a significant milestone for IASO Bio, following the recent FDA approval of their in-house developed CT103A for relapsed/refractory multiple myeloma (RRMM) clinical trials. This achievement marks an important step in the company's international expansion strategy, as it aims to accelerate overseas clinical trial programs and develop innovative immunotherapy drugs to benefit patients globally.
IASO-782 Injection is a fully human monoclonal antibody that specifically targets CD19, a surface antigen found on B cells throughout their development stages. Many autoimmune diseases, including ITP and AIHA, are primarily driven by auto-reactive antibodies produced by pathogenic B and plasma cells. IASO-782 has demonstrated the ability to efficiently deplete CD19+ B cells, plasmablast cells, and certain plasma cells, thereby reducing or eliminating the production of auto-reactive antibodies. This mechanism of action holds promise for the treatment of various autoimmune diseases associated with such antibodies.
ITP is a rare disorder characterized by impaired blood clotting due to low platelet levels, with a higher prevalence among females. In the United States, the incidence and prevalence of ITP are estimated to be 6.0 and 20.3 per 100,000, respectively. In China, the incidence and prevalence are approximately 2.9 and 11.02 per 100,000, respectively, with the primary type accounting for about 79% of cases. In 2022, it is estimated that there will be 68,000 and 156,000 ITP patients in China and the United States, respectively.
Warm autoimmune hemolytic anemia (wAIHA) is the most common form of autoimmune hemolytic anemia, representing 70% to 80% of cases. The incidence of wAIHA ranges from 0.1 to 0.5 per 100,000, with a prevalence of about 0.3 to 1 per 100,000 in Asian populations and 1.77 per 100,000 with a prevalence of approximately 17 per 100,000 in European populations.
The FDA's approval of IASO Bio's IND application for IASO-782 Injection sets the stage for further clinical development and potential treatment options for patients with autoimmune hematological disorders on a global scale.