预约演示

IASO Bio Announces NMPA Approval of IND Application for IASO-782 for Treatment of New Indication -- Systemic Lupus Erythematosus (SLE)

2024-07-25

交易

临床申请免疫疗法细胞疗法上市批准临床研究

SHANGHAI, NANJING, China and SAN JOSE, Calif. , July 25, 2024 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing innovative cell therapy and antibody products, hereby announces that

the investigational new drug (IND) application for IASO-782 Injection, a fully human monoclonal antibody targeting human CD19, has been approved by the National Medical Products Administration (NMPA) for the treatment of a new indication — systemic lupus erythematosus (SLE).

Prior to this approval, the IASO-782 Injection has received IND approval in both China and the U.S. for the treatment of immune thrombocytopenic purpura (ITP) and warm autoimmune hemolytic anemia (wAIHA). The latest approval for the indication of SLE further expands the therapeutic scope of the IASO-782 Injection, once again demonstrated IASO Bio's innovative capabilities in the biopharmaceutical field and its profound understanding of patient needs.

Dr. Jie Chen, Chief Medical Officer of IASO Bio, stated: "Autoimmune diseases are the strategic focus for IASO Bio. Since last year, IASO-782 Injection has successfully received approval for three INDs in China and the U.S respectively The CAR T therapy Equecabtagene Autoleucel Injection has also received NMPA IND approval for the treatment of neuromyelitis optica spectrum disorder and refractory generalized myasthenia gravis. Cabaletta Bio, one of IASO Bio's partners, licensed IASO's CD19 binder and developed CD19-targeting CAR-T to treat autoimmune diseases. It has received IND approval from the US Food and Drug Administration for the treatment of four autoimmune indications, including SLE. IASO Bio will continue to collaborate with our peers to further promote innovation and development in the treatment of autoimmune diseases, so as to bring significant clinical benefits to patients through innovative therapies."

About Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosus (SLE) is a systemic autoimmune disease. It is one of the earliest human diseases identified to be associated with abnormalities in B lymphocytes and autoimmunity. SLE is characterized by the involvement of multiple systems and organs, with a natural course marked by alternating periods of exacerbation and remission, and the presence of numerous autoantibodies. If not treated promptly, SLE may cause irreversible damage to the organs involved, ultimately leading to death. According to the Frost & Sullivan report, there were approximately 8.049 million SLE patients worldwide in 2023, with approximately 1.048 million SLE patients in China. The prevalence ratio of SLE between males and females is about 1:10-12 [1].

About IASO-782 Injection

IASO-782 Injection is a fully human monoclonal antibody targeting human CD19, with Fc mutations to enhance ADCC function while keeping the other Fc functions, such as ADCP, intact. The B cell surface antigen CD19 is expressed throughout B cell development, from pre-B cells through plasmablasts. It is also expressed in some plasma cells. Many autoimmune diseases, such as ITP and AIHA, are mainly mediated by auto-reactive antibodies produced by pathogenic B & plasma cells. IASO-782 can efficiently deplete CD19+ B cells, plasmablasts, and some plasma cells, thus reducing or completely eliminating auto-reactive antibodies produced by these cells. IASO-782 has the potential to treat a range of autoimmune diseases associated with auto-reactive antibodies. As IASO-782 is a fully human antibody, it has potentially low immunogenicity and is less likely to induce anti-drug antibodies after repeated administration. This provides a potential advantage for the treatment of autoimmune diseases that require long-term, repeated administration.

REFERENCE

1. Zhang Xiao, et al. '2020 Chinese guidelines for the diagnosis and treatment of systemic lupus erythematosus'. Rheumatology and Immunology Research 1, no. 1 (1 December 2020): 5–23. https://doi.org/10.2478/rir-2020-0009.

About IASO Bio

IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercial production.

The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of R/RMM.

Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit http://www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics.

SOURCE IASO Bio