EAN Annual Meeting Highlights: IASO Bio's Eque-cel (Idecabtagene Vicleucel) Demonstrates Promising Efficacy and Safety in Progressive Multiple Sclerosis

Jun 23, 2025 09:30 CST Updated 09:30

IASO Biotechnology

Cancer Treatment New Drug Developer

On June 22, the investigator-initiated clinical study (IIT) supported by IASO Bio on the treatment of multiple sclerosis (MS) with the BCMA-targeted CAR-T cell therapy injection drug Equecabtagene Autoleucel was presented as an online oral report at the 11th annual meeting of the European Academy of Neurology (EAN). The latest research data was showcased. The research results showed,Iasoten InjectionShowed good tolerance and significant efficacy in patients with progressive multiple sclerosis.

Report Title:Targeted BCMA CAR-T Cell Therapy for the Treatment of Multiple Sclerosis Patients

Report Type:Online Oral Report

Report Time:June 22, 2025, 14:00-14:05 (EEST)

Reporting Location:Helsinki, Finland

Abstract Number:A-25-13667

Reporter:Professor Qin Chuan from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

This report is based on the results of an investigator-initiated exploratory clinical study (NCT04561557) evaluating the efficacy and safety of infusing Icarus Bio's Iciclenin injection for the treatment of progressive multiple sclerosis (MS). The study is being conducted at Tongji Hospital, affiliated with Tongji Medical College of Huazhong University of Science and Technology, by a research team led by Professor Wei Wang from the Department of Neurology at Tongji Hospital.

Efficacy

As of December 31, 2024, the study enrolled three patients with advanced 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 therapy. After receiving a single infusion of Icarus cell injection (1.0×10^6 cells/kg),The patient showed rapid and sustained clinical improvement:

Functional Improvement:At the last follow-up, all patients showed significant improvement in EDSS scores compared to baseline; upper limb dexterity (Nine-Hole Peg Test) and lower limb walking ability (25-Foot Walk Test) were significantly enhanced.

Biomarker Turned Negative:Complete disappearance of oligoclonal bands (OCBs) in cerebrospinal fluid; significant reduction in K free light chain levels;

Radiographic Stability:MRI复查未发现新发或扩大的钆增强T1病灶及T2高信号病灶。

Safety

All patients experienced transient Grade 1 cytokine release syndrome (CRS), and no immune effector cell-associated neurotoxicity syndrome (ICANS) or other neurotoxicity reactions were observed post-infusion.

≥Grade 3 cytopenia occurred within 30 days after CAR-T cell infusion, with only ≥Grade 3 neutropenia and lymphocyte count reduction observed; no cases of ≥Grade 3 anemia or thrombocytopenia were reported.

Conclusion:Idecabtagene Vicleucel Injection Demonstrates Good Tolerability and Significant Efficacy in the Treatment of Multiple Sclerosis, Specifically Improving Physical Function and Eliminating Oligoclonal Bands (OCBs) in Cerebrospinal Fluid.

References:

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.

About Multiple Sclerosis (MS)

Multiple sclerosis is a neuroinflammatory disease that affects the central nervous system (CNS), leading to demyelination and neuronal damage. It is one of the most common causes of non-traumatic disability in young adults (18 to 40 years old).¹According to the Frost & Sullivan report, there were approximately 3.07 million patients with multiple sclerosis globally in 2023, including about 400,000 in the United States. The prevalence of multiple sclerosis shows significant gender differences, with an overall female-to-male ratio of 3:1.²Multiple sclerosis is characterized by localized lymphocytic infiltration of the central nervous system, leading to myelin destruction and axonal damage, which can result in neurological syndromes and physical disability.³The clinical manifestations of multiple sclerosis depend on the location of damage in the central nervous system. Common symptoms include sensory and visual disturbances, motor and coordination disorders, as well as spasticity, fatigue, pain, and cognitive deficits.⁴Approximately 85% to 90% of patients with multiple sclerosis experience a relapsing-remitting course, characterized by acute exacerbations followed by periods of remission. However, as the disease progresses and recovery becomes incomplete, about 50% of patients eventually develop secondary progressive multiple sclerosis, marked by the gradual and irreversible accumulation of neurological disability.⁵。

About Eque-cel Injection

Eque-cel 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...With rapid and potent efficacy, as well as remarkable persistence in the body, it can provide patients with deep and lasting relief.

About IASO Bio

IASO Bio, established in 2017, is a leading biopharmaceutical company focusing on the research, production, and sales of innovative cell therapies. The company has built its innovative foundation on developing cellular drugs for hematological tumors and expanded into autoimmune diseases and antibody-based drugs. It possesses comprehensive full-process capabilities from early drug discovery, clinical development, regulatory submission to commercialization. IASO Bio currently has more than 10 innovative drug candidates at various stages of development, including the world’s first fully human CAR-T product, an anti-BCMA injectable named Equecabtagene Autoleucel (brand name: Focasux).^®) was approved for marketing by the China National Medical Products Administration (NMPA) in June 2023 for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent). Its frontline indication for the treatment of 2-3 line multiple myeloma (MM) has entered Phase III clinical trials. In addition, Ixalocel injection has received multiple Investigational New Drug (IND) approvals in both China and the United States for various autoimmune diseases.

At the same time, the dual-target (CD19/CD22) product CT120 for lymphoma is about to enter Phase II clinical trials. Another product targeting GPRC5D for the treatment of relapsed and refractory multiple myeloma, IASO118, has received IND approval in China. In addition to cell therapy products, the company's fully human anti-CD19 antibody product, IASO-782, has received IND approval in both China and the United States for the treatment of multiple autoimmune diseases, while still exploring additional indications for autoimmune diseases. The company has successively partnered with overseas cell therapy company Sana.Therapeutics, Cabaletta Bio, and Umoja Biopharma have reached global commercial expansion authorization or research and development cooperation, actively exploring the development of next-generation cell therapy products. Relying on its strong management team, innovative product pipeline, self-owned GMP manufacturing, and advanced clinical development capabilities, IASO Bio is fully committed to bringing transformative, accessible innovative therapies and the hope of a cure to patients in China and around the world. For more information, please visit the company's official website: www.iasobio.com or LinkedIn page: www.linkedin.com/company/iasobiotherapeutics.