Cancer Treatment New Drug Developer

July 24, 2024, Nanjing, Shanghai, China, San Jose, California, USA — IASO Bio, a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative cell therapies, announced thatThe Investigational New Drug (IND) application for the self-developed fully human BCMA-targeted chimeric antigen receptor autologous T-cell injection (Equecabtagene Autoleucel Injection) has received tacit approval from the U.S. Food and Drug Administration (FDA) for the proposed treatment of Multiple Sclerosis (MS).). This is the second autoimmune disease indication IND for IASO Bio's equecabtagene autoleucel injection successfully approved by the FDA in 2024, following refractory generalized myasthenia gravis (gMG).
IASO Bio's Chief Scientific Officer, Dr. Yongke Zhang, stated:"IASO Bio's Icarosel Injection has been validated as effective in up to six autoimmune diseases in an investigator-initiated clinical study conducted in China. The recent FDA's tacit approval for the clinical trial application of Icarosel Injection for the treatment of multiple sclerosis is strong evidence of IASO Bio's continuous efforts and technological breakthroughs in the field of autoimmune disease treatment. We will always adhere to a research and development philosophy guided by clinical value, addressing unmet clinical needs, and place high importance on the implementation of a global strategy. Through close collaboration and in-depth exchanges with international clinical research institutions, we will accelerate the development and market launch of more innovative drugs, bringing greater benefits to patients worldwide."
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About Multiple Sclerosis (MS)
Multiple sclerosis is a neuroinflammatory disease that affects the central nervous system (CNS), leading to demyelination and neuronal damage. It is one of the most common causes of non-traumatic disability in young adults (aged 18 to 40).[1]According to the Frost & Sullivan report, there were approximately 3.07 million patients with multiple sclerosis globally in 2023, including about 400,000 in the United States. The prevalence of multiple sclerosis shows significant gender differences, with an overall female-to-male ratio of 3:1.[2]。
Multiple sclerosis is characterized by localized lymphocytic infiltration of the central nervous system, leading to demyelination and axonal damage, which result in neurological syndromes and physical disability.[3]The clinical manifestations of multiple sclerosis depend on the location of damage in the central nervous system. Common symptoms include sensory and visual disturbances, motor and coordination disorders, as well as spasticity, fatigue, pain, and cognitive deficits.[4]Approximately 85% to 90% of patients with multiple sclerosis experience a relapsing-remitting course, characterized by acute exacerbations followed by periods of remission. However, as the disease progresses and recovery becomes incomplete, about 50% of patients eventually develop secondary progressive multiple sclerosis, which is marked by the gradual and irreversible accumulation of neurological dysfunction.[5]。
About IASO Bio
References
[1] Thompson AJ, Baranzini SE, Geurts J, Hemmer B, Ciccarelli O. Multiple sclerosis. Lancet 2018; 391: 1622–36.
[2] GBD 2016 Multiple Sclerosis Collaborators. Global, regional, and national burden of multiple sclerosis 1990-2016: a systematic analysis for the Global Burden of Disease
Study 2016. Lancet Neurol 2019;18: 269–85.
[3] Compston A, Coles A. 2008. Multiple sclerosis. Lancet 372(9648):1502–17.
[4] BDendrou CA, Fugger L, Friese MA. 2015. Immunopathology of multiple sclerosis. Nat.Rev. Immunol.15(9):545–58.
[5] Sospedra M, Martin R. 2016. Immunology of multiple sclerosis. Semin. Neurol. 36:115–27.
