IASO Bio's Equecabtagene Autoleucel IND Approved by U.S. FDA for Multiple Sclerosis

IASO Biotechnology (IASO Bio), a biopharmaceutical company focused on cell therapy and antibody products, has announced that the U.S. Food and Drug Administration (FDA) has approved their investigational new drug (IND) application for Equecabtagene Autoleucel (Eque-cel) for treating multiple sclerosis (MS). This marks the second FDA IND approval for Eque-cel in 2024, following its approval for refractory generalized myasthenia gravis (gMG).

Dr. Yongke Zhang, Chief Scientific Officer of IASO Bio, highlighted the promising efficacy of Eque-cel in treating six autoimmune diseases in an investigator-initiated trial (IIT) conducted in China. He emphasized that the FDA's IND approval for the treatment of MS underscores IASO Bio's commitment to addressing autoimmune diseases through innovative therapies. Dr. Zhang stated that the company aims to prioritize clinical value and global strategy, striving for collaboration with international clinical research institutions to accelerate the development and commercialization of new drugs worldwide.

Multiple sclerosis (MS) is a neuroinflammatory disease of the central nervous system (CNS) that leads to demyelination and neuronal injury. It is one of the most prevalent causes of non-traumatic disability among young adults aged 18 to 40 years. In 2023, approximately 3.07 million people globally suffered from MS, with about 400,000 cases in the United States. The disease shows a significant gender disparity, with a female-to-male ratio of 3:1.

MS is marked by focal lymphocytic infiltration in the CNS, resulting in myelin destruction and axonal damage. This leads to various neurological syndromes and physical disabilities. The clinical manifestations of MS depend on lesion locations in the CNS and can include sensory and visual disturbances, motor and coordination impairments, spasticity, fatigue, pain, and cognitive deficits. Around 85% to 90% of MS patients experience a relapsing-remitting form of the disease, characterized by periods of symptom exacerbation followed by remission. As MS progresses, recovery from symptoms becomes incomplete, and approximately 50% of patients may develop secondary progressive MS, which involves the progressive, irreversible accumulation of neurological disability.

IASO Bio is a biopharmaceutical company dedicated to creating and developing advanced cell therapies and biologics for oncology and autoimmune diseases. The company has a robust pipeline that includes over ten novel products, such as Equecabtagene Autoleucel, a fully human BCMA CAR-T injection. This drug has received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for treating relapsed/refractory multiple myeloma (R/RMM).

IASO Bio leverages its strong management team and innovative product pipeline, along with GMP production and integrated clinical capabilities, to develop transformative and affordable therapies that meet unmet medical needs. The company aims to deliver these therapies to patients in China and internationally, improving patient outcomes and overall health.

IASO Bio's recent achievements, including the FDA's IND approval for Eque-cel in treating MS, signify its ongoing efforts to advance medical treatments for autoimmune diseases. The company remains dedicated to enhancing clinical value and pursuing a global strategy to benefit patients worldwide.