Eque-cel CAR-T Cleared for Multiple Sclerosis Trial
IASO also received IND clearance for a trial in myasthenia gravis in April 2024.
Yongke Zhang, PhD
Credit: IASO Bio
The FDA has cleared IASO Bio’s investigational new drug (IND) application for its chimeric antigen receptor (CAR) T-cell therapy equecabtagene autoleucel (eque-cel) for the potential treatment of multiple sclerosis (MS).1
"In an investigator initiated trial (IIT) conducted in China, Eque-cel has shown promising efficacy in 6 autoimmune diseases. The IND approval of Eque-cel in the treatment of MS from the FDA is another strong evidence of IASO Bio's ongoing dedication and technological advancements in the treatment of autoimmune diseases. We will continue to adhere to the research and development philosophy that prioritizes clinical value to address unmet clinical needs and will place great importance on implementing a global strategy. Through close collaboration and in-depth exchanges with international clinical research institutions, we aim to accelerate the development and commercialization of more innovative drugs, bringing greater benefits to patients worldwide,” Yongke Zhang, PhD, Chief Scientific Officer, IASO Bio, said in a statement.1
Eque-cel is an independently developed fully human anti-BCMA CAR T-cell therapy initially investigated for treating multiple myeloma. IASO Bio has been exploring its use for treating central nervous system autoimmunity. The company recently reported on eque-cel's use in neuromyelitis optica spectrum disorder (NMOSD), myasthenia gravis (MG), and immune-mediated necrotizing myopathy (IMNM), and also received IND clearance for a trial in generalized myasthenia gravis (gMG) in April 2024.2,3,4,5
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The recent case reports are part of a clinical phase 1 program (NCT04561557) investigating eque-cel in nervous system autoimmunity indications. In 2 patients with MG, clinical symptoms were reported to continue to improve over the 18 months following infusion of the CAR-T product. Furthermore, significant improvements in limb strength and vital capacity were observed at 3 months posttreatment, as were sustained improvements on instruments including the Myasthenia Gravis-Activities of Daily Living Score, Quantitative Myasthenia Gravis Score, Myasthenia Gravis-Quality of Life Score, and Modified Rankin Score.2
“MG has a long course, is difficult to cure, and is prone to recurrence. Current treatment with traditional medications, although is able to improve symptoms of MG to a certain extent, is deficient in terms of disease control and long-term safety, and there is an urgent need for patients to have a better clinical outcome and treatment modality. In our study, it is gratifying to see that BCMA CAR-T cell therapy can prevent MG disease progression and show signs of reversal of the disease, which is expected to change the MG treatment landscape and bring hope for a cure to patients,” principal investigator Professor Wei Wang from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, said in a statement.2
