IASO Bio presents promising efficacy of Equecabtagene Autoleucel in patients with Multiple Sclerosis in IIT study at the 11th Congress of the European Academy of Neurology (EAN)

SHANGHAI and NANJING, China and SAN FRANCISCO, June 23, 2025 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, today announced that results from an investigator-initiated (IIT) study evaluating its anti-BCMA CAR-T product, Equecabtagene Autoleucel, for the treatment of multiple sclerosis (MS) were presented as an e-presentation at the 11th Congress of the European Academy of Neurology (EAN). The study has demonstrated that Equecabtagene Autoleucel are well tolerated and highly effective in treating progressive MS.

Title: Anti-BCMA CAR T cell therapy in patients with Multiple Sclerosis

Type: E-presentation

Time: 14:00 – 14:05 (Eastern European Summer Time), June 22, 2025

Location: Helsinki, Finland
Abstract ID: A-25-13667
Presenter: Prof. Chuan Qin, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

This presentation is based on findings from an investigator-initiated clinical study (NCT04561557) evaluating the efficacy and safety of Equecabtagene Autoleucel in the treatment of progressive multiple sclerosis. The study is currently being conducted at Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, which is led by Professor Wei Wang's team from the Department of Neurology.

Efficacy: As of December 31, 2024, the study enrolled 3 patients with progressive multiple sclerosis (MS) (2 with secondary progressive MS and 1 with primary progressive MS), with baseline Expanded Disability Status Scale (EDSS) scores of 6-7 and failed with prior biologic therapy. Following a single infusion of Eque-cel (1.0×10^6 cells/kg), the patients demonstrated rapid and sustained clinical improvement:

• Functional Improvement: All patients showed significant EDSS score decrease compared with baseline, with improved upper limb dexterity (9-Hole Peg Test) and lower limb walking ability (25-Foot Walk Test).
• All patients showed resolution of oligoclonal bands and significant reduction of free light chain kappa in cerebrospinal fluid (CSF).
• MRI revealed no new or enlarged T1 gadolinium-enhancing lesions or T2 hyperintense lesions were found in all patients.

Safety:

• All patients experienced transient grade 1 CRS. No ICANS or other neurologic toxic effects were observed post infusion.
• All grade ≥3 cytopenias occurred within 30 days after CAR-T infusion. Only grade ≥3 neutropenia and Lymphopenia were observed, with no occurrence of grade ≥3 anemia or thrombocytopenia.

Conclusion: Equecabtagene Autoleucel is well tolerated and highly effective in treating progressive MS, demonstrated by the improvement in physical function and the resolution of oligoclonal bands (OCBs) in CSF.

About Multiple Sclerosis

Multiple sclerosis (MS), a neuroinflammatory disease of the central nervous system (CNS) that causes demyelination and neuronal injury, is one of the most common causes of non-traumatic disability among young adults (aged 18–40 years)^[1]. According to Frost & Sullivan, in 2023, about 3.07 million patients suffered from MS worldwide, of which approximately 400 thousand were in the United States. MS prevalence differs substantially between sexes, with a female to male ratio of 3:1^[2].

MS is characterized by focal lymphocytic CNS infiltration leading to myelin destruction and axonal damage, which result in neurologic syndromes and physical disability^[3]. MS clinical manifestations depend on the location of lesions in the CNS. Symptoms may include sensory and visual disturbances; motor and coordination impairment; and spasticity, fatigue, pain, and cognitive deficits^[4]. About 85%–90% of MS patients develop a relapsing-remitting form of the disease, which is characterized by periods of symptom exacerbation followed by remission. As the disease evolves, the recovery from symptoms is incomplete, and around 50% of patients eventually develop a form of the disease known as secondary progressive MS, which is characterized by the progressive, irreversible accumulation of neurologic disability^[5].

About Equecabtagene Autoleucel (Eque-cel)

Equecabtagene Autoleucel (Eque-cel) is an innovative fully human anti-BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully human scFv, CD8a hinge and transmembrane, and 4-1BB co-stimulatory and CD3ζactivation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, Eque-cel demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve higher and deeper responses.

About IASO Bio

IASO Bio is a biopharmaceutical company focused on the discovery and development of innovative cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercialization.

Its pipeline includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received Biologics License Application (BLA) approval from China's National Medical Products Administration (NMPA) in June 2023and U.S. FDA IND approval for the treatment of R/RMM in December 2022.

Leveraging its strong management team, innovative product pipeline, as well as integrated and high quality manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China and around the world. For more information, please visit http://www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics. 

Reference

1. Thompson AJ, Baranzini SE, Geurts J, Hemmer B, Ciccarelli O. Multiple sclerosis. Lancet 2018; 391: 1622–36.

2. GBD 2016 Multiple Sclerosis Collaborators. Global, regional, and national burden of multiple sclerosis 1990-2016: a systematic analysis for the Global Burden of Disease

Study 2016. Lancet Neurol 2019;18: 269–85.

3. Compston A, Coles A. 2008. Multiple sclerosis. Lancet 372(9648):1502–17.

4. BDendrou CA, Fugger L, Friese MA. 2015. Immunopathology of multiple sclerosis. Nat.Rev. Immunol.15(9):545–58.

5. Sospedra M, Martin R. 2016. Immunology of multiple sclerosis. Semin. Neurol. 36:115–27.