Iaso Bio's BCMA-Targeting CAR-T Therapy Receives FDA IND Clearance for Multiple Sclerosis Six Months After Prior Autoimmune Indication

　　【Pharmaceutical Network Product InformationOn July 24, IASO Bio announced good news: the Investigational New Drug (IND) application for its 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). It is intended for the treatment of multiple sclerosis.
 

Multiple Sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system, with the immune system involved in its onset and progression, and is listed in China's rare disease catalog. Relevant data shows that there are approximately 2.9 million people worldwide living with multiple sclerosis. Currently, there is no drug that can cure MS, but existing treatments can alter the course of the disease, leaving a significant unmet treatment need for many patients. If IASO Bio's Equecabtagene Autoleucel Injection successfully receives FDA approval in the future, it will bring new treatment options to patients.
 

Notably, this is the second IND approval for IASO Bio's equecabtagene autoleucel injection for autoimmune disease indications from the FDA this year.
 

According to reports, in January this year, the Investigational New Drug (IND) application for Ixcellen Injection was granted tacit approval by the U.S. Food and Drug Administration (FDA) for the treatment of refractory generalized myasthenia gravis (gMG). The IND for this indication in China was approved by the NMPA in January this year.
 

Myasthenia Gravis (MG) is a disease mediated by autoantibodies that disrupt neuromuscular junction transmission. Its main clinical manifestations include reduced muscle strength in local or systemic muscles, affecting important muscle groups such as ocular, respiratory, and limb muscles, significantly negatively impacting the patient's quality of life. Moreover, myasthenic crisis-induced swallowing or breathing difficulties can be life-threatening. The primary pathogenic antibodies in MG include AChR, MuSK, and LRP4 antibodies, while a small number of patients have no detectable levels of the aforementioned antibodies in their serum. According to relevant research, it is estimated that there will be approximately 10,000 new cases of MG in the United States in 2023, with about 124,000 total cases.
 

In China, Idecabtagene Vicleucel Injection was officially approved for marketing by the National Medical Products Administration (NMPA) on June 30, 2023. It has become the world's first commercially available fully human CAR-T product, as well as China’s first self-developed and fully in-house manufactured CAR-T cell therapy, the first domestically approved BCMA-targeted CAR-T product, and the first cell therapy product approved in China for the treatment of multiple myeloma. On March 28, 2024, the Investigational New Drug (IND) application for this medicine was again approved, with plans to expand its indications to treat patients with relapsed/refractory multiple myeloma who have undergone 1-2 prior lines of therapy and are lenalidomide-resistant.
 

Public information shows that IASO Bio is a biopharmaceutical company dedicated to the research, production, and sales of innovative cell drugs. With the development of hematological tumor cell-based drugs and antibody drugs as its innovative foundation, the company has expanded into autoimmune diseases and possesses comprehensive capabilities across the entire process from early discovery, clinical development, regulatory submission, to commercial-scale production.
 

The company currently has more than 10 innovative drug candidates at different stages of development. Among them, the injection of Equecabtagene Autoleucel (a fully human BCMA CAR-T product) has been approved by the National Medical Products Administration (NMPA) for marketing in China to treat relapsed/refractory multiple myeloma. Meanwhile, this product has also received FDA approval to conduct clinical trials in the United States, showing potential for future growth.
 

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