SHANGHAI, NANJING,
China and SAN JOSE, Calif., July 23,
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.
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SOURCE IASO Bio