Iaso Bio Announces Promising Clinical Results of BCMA-Targeted CAR-T Therapy Eque-cel in Progressive Multiple Sclerosis

　　【Pharmaceutical Network Enterprise News] At the recently held 11th annual meeting of the European Academy of Neurology (EAN), a clinical study (IIT) on the treatment of multiple sclerosis (MS) using IASO Bio's supported BCMA-targeted CAR-T cell therapy, Ixmyelocel-T injection, was presented in the form of an online oral report, showcasing new research data.
 

Multiple sclerosis is an immune-mediated chronic inflammatory demyelinating disease of the central nervous system, which can affect multiple areas such as the periventricular region, near cortex, optic nerve, spinal cord, brainstem, and cerebellum. Its etiology and pathogenesis remain unclear and may be related to viral infections, genetic factors, and environmental factors. Patients exhibit diverse clinical manifestations, with common symptoms including limb weakness, sensory abnormalities, decreased vision, and diplopia, significantly impacting quality of life. Currently, the treatment of MS faces numerous challenges, especially for progressive MS, where patients often show poor response to existing treatments, creating an urgent need for new therapeutic approaches.
 

Eque-cel (Idecabtagene Vicleucel) Injection is a CAR-T cell therapy targeting B-cell maturation antigen (BCMA). It uses lentivirus as a gene vector to transfect autologous T cells. The CAR comprises a fully human scFv, CD8a hinge and transmembrane domain, 4-1BB co-stimulatory molecule, and CD3ζ activation domain. Based on stringent molecular structure screening and comprehensive in vivo and in vitro functional evaluation, Eque-cel injection demonstrates rapid and potent efficacy with remarkable in vivo persistence, enabling patients to achieve deep and sustained remission. Previously, Eque-cel injection has been approved for treating adult patients with relapsed or refractory multiple myeloma (R/R MM), and its exploration in the field of autoimmune diseases has also gained significant attention.
 

This report is based on the results of an investigator-initiated exploratory clinical study (NCT04561557) evaluating the efficacy and safety of infusing Icaritin Celastrol Injection for the treatment of progressive multiple sclerosis (MS). As of December 31, 2024, the study enrolled three patients with severe progressive MS (two with secondary progressive MS and one with primary progressive MS), with baseline EDSS scores (Expanded Disability Status Scale) reaching 6-7 points, all of whom had previously failed biologic treatments. After receiving a single infusion of Icaritin Celastrol Injection (1.0×10^6 cells/kg), the patients demonstrated rapid and sustained clinical improvement. At the last follow-up, all patients showed significant improvement in EDSS scores from baseline; upper limb dexterity (Nine-Hole Peg Test) and lower limb walking ability (25-foot walk test) were notably enhanced. Additionally, biomarker negativity was observed as cerebrospinal fluid oligoclonal bands (OCBs) completely disappeared, and K free light chain levels significantly decreased. In terms of radiological stability, MRI reexamination revealed no new or enlarging gadolinium-enhanced T1 lesions or T2 hyperintense lesions.
 

Relevant experts noted that the data from this study is encouraging. The Icarusel injection has shown great potential in treating progressive multiple sclerosis. It not only improved patients' physical functions but also turned key biomarkers negative, bringing new hope to MS patients.
 

Data shows that IASO Bio, as a biopharmaceutical company dedicated to the research, production, and sales of innovative cell and antibody drugs, has been actively promoting the study of Equecabtagene Autoleucel Injection across various disease areas. The company currently has more than 10 innovative drug candidates at different stages of development. In addition to making progress in multiple myeloma and MS, its dual-target (CD19/CD22) product CT120 for lymphoma is about to enter Phase II clinical trials. The GPRC5D-targeting product IASO118 for the treatment of relapsed or refractory multiple myeloma has received IND approval in China. Additionally, the fully human anti-CD19 antibody product IASO-782 has obtained IND approval in both China and the United States for the treatment of multiple autoimmune diseases.
 

The research findings of IASO Bio's Ixazomib Injection for the treatment of MS debuted at the EAN Annual Meeting, injecting new vitality into the global MS treatment field. With ongoing in-depth research and expansion, Ixazomib Injection is expected to offer effective treatment options for more patients with refractory autoimmune diseases, transforming the treatment landscape of autoimmune diseases.
 

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