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.
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SOURCE IASO Bio