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IASO Bio Secures FDA Approval for Equecabtagene Autoleucel IND Application to Treat Multiple Sclerosis

NextEdge Admin

25 Jul 2024

3 min 2 sec

IASO Biotechnology ("IASO Bio"), a biopharmaceutical company specializing in innovative cell therapy and antibody products, announced that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application for their fully human anti-BCMA chimeric antigen receptor autologous T cell injection (Equecabtagene Autoleucel, Eque-cel) for treating multiple sclerosis (MS). This marks the second FDA IND approval for Eque-cel in 2024, following approval for refractory generalized myasthenia gravis (gMG).

Dr. Yongke Zhang, Chief Scientific Officer of IASO Bio, highlighted Eque-cel's promising efficacy in six autoimmune diseases during a China-based investigator-initiated trial (IIT). He emphasized that the IND approval for MS demonstrates IASO Bio's commitment to advancing autoimmune disease treatments. IASO Bio aims to address unmet clinical needs through a global strategy, collaborating closely with international clinical research institutions to accelerate drug development and commercialization, ultimately benefiting patients worldwide.

Multiple sclerosis (MS) is a neuroinflammatory disease of the central nervous system (CNS) that leads to demyelination and neuronal injury, commonly causing non-traumatic disability in young adults. In 2023, Frost & Sullivan reported that approximately 3.07 million people worldwide, including 400,000 in the U.S., suffered from MS. The disease predominantly affects women (3:1 ratio) and is characterized by lymphocytic CNS infiltration, leading to myelin destruction and axonal damage. Symptoms vary depending on lesion location in the CNS and can include sensory and visual disturbances, motor impairment, spasticity, fatigue, pain, and cognitive deficits. Most MS patients experience a relapsing-remitting form of the disease, with around 50% eventually developing secondary progressive MS.

IASO Bio is dedicated to discovering and developing novel cell therapies and biologics for oncology and autoimmune diseases, boasting a diverse pipeline of over 10 innovative products, including Eque-cel. With strong management, GMP production capabilities, and comprehensive drug development processes, IASO Bio aims to provide transformative, affordable therapies to patients in China and globally.