▎Edited by the WuXi AppTec content teamOn January 25, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that IASO Bio's BCMA-targeted CAR-T product, Equecabtagene Autoleucel Injection, has been approved for clinical trials for a new indication, intended for the treatment ofRefractory Generalized Myasthenia Gravis. Public information shows that IASO Bio's product was approved for marketing in China in June 2023, for the treatment of relapsed/refractoryMultiple Myeloma（MM）。This Case of Myasthenia GravisInvestigational New Drug Application (IND)The approval further expands the indications range of IASO Bio's injectable drug, following its previous...Neuromyelitis Optica Spectrum Disorders（NMOSD) The second autoimmune indication approved for IND.Screenshot source: CDE official website
Myasthenia Gravis（MG) is a type ofAutoantibody-Mediated Neuromuscular Junction Transmission Disorder，Is a rareChronic Autoimmune DiseaseDiseaseThe main clinical manifestations of MG include muscle weakness in local or systemic muscles, which can affect important muscle groups such as ocular, respiratory, and limb muscles, significantly negatively impacting the patient's quality of life. Moreover, myasthenic crisis-induced swallowing or respiratory difficulties can be life-threatening. The main pathogenic antibodies of MG include AChR, MuSK, and LRP4 antibodies. A small number of patients have no detectable serum antibodies mentioned above and are referred to as seronegative MG. This disease can occur at any age, with a slightly higher prevalence in women than in men. According to relevant research, the number of new MG cases in China in 2022 was approximately 9,600, with about 282,000 people living with the condition. Currently, most drugs for MG treatment are hormonal or non-hormonal immunosuppressants, but existing therapies only provide relief and fall short in terms of disease control and long-term safety.Idecabtagene Vicleucel Injection is aFully Human Targeted BCMA CAR-T Innovative Candidate Product. The candidate product uses lentivirus as a gene vector to transfect autologous T cells. The CAR comprises a fully human scFv, CD8a hinge and transmembrane, 4-1BB co-stimulatory, and CD3ζ activation domains. According to a previous press release from IASO Bio,Clearance of Plasma Cells Through BCMA-CART Cell Therapy，Provides New Treatment Strategies for a Major Class of Autoimmune Diseases Caused by Autoreactive Antibodies Produced by Plasma Cells。Ms. Jin Hua Zhang, founder and CEO of IASO Bio, stated: "For a long time, the treatment of patients with generalized myasthenia gravis (MG) has mainly relied on expert judgment and traditional treatment methods. Existing drug therapies are not effective for all patients. Clinically, 10%-15% of MG patients have refractory disease. The treatment of these refractory MG patients and those potentially progressing to myasthenic crisis presents a significant clinical challenge, urgently requiring safe and effective innovative treatments 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 reversing the disease, which is expected to transform the treatment landscape for MG. IASO Bio will expedite the initiation and completion of clinical trials, bringing hope of a cure to Chinese patients with severe myasthenia gravis."References:
[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Jan 25, 2024, fromhttps://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
[2] IASO Bio's Icarosel Injection Receives Approval for New Autoimmune Indication IND Application. Retrieved Jan 25, 2024, from https://mp.weixin.qq.com/s/TRZLYHd1JP_cK1UIGxugzg
This article was compiled and edited by the WuXi AppTec content team based on publicly available information. Individuals are welcome to share it on their social media feeds. For authorization to repost, please leave a message on the "MedView" WeChat Official Account to contact us. For other collaboration inquiries, please contact wuxi_media@wuxiapptec.com.
Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange purposes only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it indicate that WuXi AppTec supports or opposes these views. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.
