IASO Bio Initiates Phase I Clinical Trial of Fully Human Anti-CD19 Monoclonal Antibody IASO-782 in Patients with Autoimmune Hematological Diseases

Aug 09, 2024 11:20 CST Updated 11:20

IASO Biotechnology

Cancer Treatment New Drug Developer

On August 8, the patient enrollment initiation meeting for the Phase I clinical study of IASO-782 injection, a fully human CD19 monoclonal antibody product independently developed by IASO Bio, targeting autoimmune hematological diseases—including immune thrombocytopenia (ITP) and warm antibody autoimmune hemolytic anemia (wAIHA)—was successfully held in the Hematology Department of Wuhan Union Hospital, Huazhong University of Science and Technology (hereinafter referred to as "Wuhan Union Hospital"), marking...Phase I Clinical Study of IASO-782 Injection for Patients Officially LaunchedThe IND application for this new drug received implicit approval from the National Medical Products Administration (NMPA) in June 2023. Notably, the IND for the additional indication of systemic lupus erythematosus (SLE) also received implicit approval from the NMPA in July of this year.

Dr. Chen Jie

Chief Medical Officer of IASO Bio

Antibody drugs and hematological tumor cell therapies are the two core drivers of IASO Bio. Autoimmune diseases are our key strategic focus. IASO-782 Injection, as the first antibody product from IASO Bio, targets multiple autoimmune indications. We will fully advance its clinical development to complement our CAR-T products, comprehensively position ourselves in the autoimmune market, and provide patients with more diversified treatment options.

About IASO-782 Injection

IASO-782 Injection is a fully human anti-CD19 monoclonal antibody that enhances antibody-dependent cell-mediated cytotoxicity (ADCC) through modifications to the crystallizable fragment (Fc) of the antibody. It eliminates CD19+ B cells and plasma cells via ADCC and antibody-dependent cellular phagocytosis (ADCP), thereby reducing the production of autoantibodies to treat antibody- or B cell-mediated autoimmune diseases. Meanwhile, as a fully human antibody, IASO-782 has low immunogenicity potential, making it less likely to induce anti-drug antibodies with repeated dosing, offering a potential advantage for treating autoimmune diseases requiring long-term, repeated administration.

About IASO Bio

IASO Bio is a biopharmaceutical company dedicated to the research, production, and sales of cell-based innovative drugs. With a focus on developing cellular therapies for hematological malignancies and antibody drugs as its innovation cornerstone, the company has expanded into autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire process from early discovery, clinical development, regulatory submission, to commercial-scale production.

The company currently has more than 10 innovative drug candidates at various stages of development. Among them, the injection of Ixazomib (a fully human BCMA CAR-T product) has been approved for marketing by the National Medical Products Administration (NMPA) in China and has received permission from the U.S. FDA to conduct registration clinical trials for the treatment of relapsed/refractory multiple myeloma.

IASO Bio, with its strong management team, innovative product pipeline, self-owned GMP manufacturing, and robust clinical development capabilities, aims to provide transformative and curative innovative therapies, bringing hope of a cure to patients in China and around the world.

For more information, please visit the company's official website: www.iasobio.com or LinkedIn account: www.linkedin.com/company/iasobiotherapeutics.