IASO Bio Announces NMPA Approval of IND Application for Equecabtagene Autoleucel (CT103A) in Generalized Myasthenia Gravis

Nanjing, Shanghai, and San Jose, California, USAJanuary 26, 2024/PR Newswire/ --IASO BioNanjing IASO Biotherapeutics Co., Ltd., a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative cell therapies, announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has officially approved the Investigational New Drug (IND) application (acceptance number: CXSL2300759) for its fully human BCMA-targeted chimeric antigen receptor autologous T-cell injection (Equecabtagene Autoleucel Injection, R&D code CT103A) for the expanded indication of refractory generalized Myasthenia Gravis (Myasthenia Gravis, MG).

Equecabtagene Autoleucel Injection (Trade Name: Fokesu)^®) was approved for marketing by the National Medical Products Administration on June 30, 2023, for the treatment of relapsed or refractory multiple myeloma. The approval of this IND for myasthenia gravis further expands the indications for Idecabtagene Vicleucel Injection, marking its second approved IND in the autoimmune field following neuromyelitis optica spectrum disorder (NMOSD). IASO Bio is the first company in China to apply CAR-T products for autoimmune indications, which is expected to transform the treatment landscape of autoimmune diseases.

About Myasthenia Gravis

Myasthenia Gravis (MG) is a disease mediated by autoantibodies that impairs neuromuscular junction transmission. The main clinical manifestations of MG include reduced muscle strength in localized or generalized muscles, affecting important muscle groups such as the eye muscles, respiratory muscles, and limb muscles, significantly negatively impacting the patient's quality of life. Moreover, myasthenic crisis-induced swallowing or breathing difficulties can be life-threatening. The primary pathogenic antibodies in MG include AChR, MuSK, and LRP4 antibodies. A small number of patients have no detectable levels of the aforementioned antibodies in their serum and are referred to as seronegative MG.¹MG can occur at any age, with a slightly higher prevalence in women than in men.²According to relevant research, the number of new MG cases in China in 2022 was approximately 9,600, with the total number of patients being approximately 282,000.^2,3Currently, the drugs for treating MG in China are mostly hormones or non-hormonal immunosuppressants, but the existing therapies can only provide relief and have shortcomings in disease control and long-term safety.⁴。

Ms. Jinhua Zhang, Founder and Chief Executive Officer of IASO Bio, stated:"For a long time, the treatment of patients with generalized myasthenia gravis has mainly relied on expert judgment and traditional treatment options. Existing drug therapies are not effective for all patients, and clinically, 10%-15% of MG patients have refractory disease."⁴, The treatment of these refractory MG patients and those potentially developing into crisis poses an important clinical challenge. There is an urgent need for safe and effective innovative therapies to address these issues. In our IIT study, we are pleased to see that the injection of Equecabtagene Autoleucel can halt disease progression and shows early signs of disease reversal, which is expected to change the treatment landscape of MG. IASO Bio will initiate and complete clinical trials as soon as possible, bringing hope of a cure to Chinese patients with myasthenia gravis."

About IASO Bio

IASO Bio is a biopharmaceutical company dedicated to the research, production, and sales of innovative cell-based drugs. With a focus on developing cellular therapies and antibody drugs for hematological malignancies as its innovative foundation, the company has expanded into autoimmune diseases, possessing comprehensive capabilities across the entire process from early discovery, clinical development, regulatory submission, to commercial-scale manufacturing.

The company currently has more than 10 innovative drug candidates at various stages of development. Among them, the injection of Ixazomib (a fully human BCMA CAR-T product) has been approved for marketing by the National Medical Products Administration (NMPA) and has received FDA approval for registration clinical trials in the United States for the treatment of relapsed/refractory multiple myeloma.

IASO Bio, with its strong management team, innovative product pipeline, self-owned GMP manufacturing, and powerful clinical development capabilities, aims to provide transformative and curative innovative therapies, bringing hope of a cure to patients in China and around the world.

For more information, please visit the company's official website:www.iasobio.comOr LinkedIn account:www.linkedin.com/company/iasobiotherapeutics。

References

1. Guidelines for the Diagnosis and Treatment of Myasthenia Gravis in China (2020) Edition

2.  Incidence, mortality, and economic burden of myasthenia gravis in China: A nationwide population-based study - The Lancet Regional Health – Western Pacific.

3.  Hospital and healthcare insurance system record–based epidemiological study of myasthenia gravis in southern and northern China  |  Neurological Sciences.

4. "2023 NCN Expert Interview | Breakthrough Therapies and Clinical Applications for Refractory Myasthenia Gravis," Neurology Channel of Medicine, September 11, 2023