IASO Bio Receives U.S. FDA Approval of Investigational New Drug Application for Equecabtagene Autoleucel for Multiple Sclerosis

SHANGHAI, NANJING, China and SAN JOSE, Calif., July 24, 2024 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing innovative cell therapy and antibody products, announced that the investigational new drug (IND) application for the independently developed fully human anti-BCMA chimeric antigen receptor autologous T cell injection (Equecabtagene Autoleucel, Eque-cel) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple sclerosis (MS). This is the second FDA IND approval of Eque-cel for the treatment of autoimmune diseases in 2024, following refractory generalized myasthenia gravis (gMG).

Dr. Yongke Zhang, Chief Scientific Officer of IASO Bio, stated: "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. "

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, about3.07 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 IASO Bio

IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel 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 commercial production.

The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of R/RMM.

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

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.