Precision Bio Announces IND Approval for Its First Autoimmune CAR-T Therapy MC-1-50 Targeting Refractory Systemic Lupus Erythematosus
Precision Biotech
Gene and Cell Therapy Developer
September 20, 2024
eMedClub News
On September 19, Chongqing Precision Biotech Co., Ltd. announced that the new indication for its injectable MC-1-50 cell preparation has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).Intended for the treatment of adult refractory systemic lupus erythematosus (SLE). This indication is the first innovative drug pipeline that the company has applied for in the field of autoimmune diseases.
SLE is a chronic autoimmune disease that affects multiple organ systems, known as the "uncurable cancer," impacting the health and quality of life of millions of people in China, especially women of childbearing age between 20 and 40. Traditional treatments mainly focus on controlling disease activity, improving clinical symptoms, and preventing and reducing relapses. Less than 1% of patients achieve complete disease remission without medication, often accompanied by severe side effects. With the successful application of CAR-T in the autoimmune field, it is expected to become a crucial treatment for SLE, improving the therapeutic challenges faced by SLE patients.
MC-1-50 is a proprietary product developed by the company based on PRIMCAR.®The second-generation CD19-targeted CAR-T cell therapy developed by the platform is a novel, faster, and more efficient CAR-T preparation solution. The product features a lower dosage, fewer side effects, and longer persistence. The MC-1-50 autoimmune indication is the third indication following B-cell acute lymphoblastic leukemia and non-Hodgkin lymphoma.
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MC-1-50 is currently conducting an IIT clinical study treating refractory SLE patients. Among the two patients who have completed infusion, DORIS remission (SLE Disease Activity Index score of 0) was achieved at 2 months and 6 months post-infusion, respectively. Neither patient resumed the use of hormones or immunosuppressants, and other SLE treatment drugs were also discontinued. Both patients only experienced grade 1 CRS, fully demonstrating the potential of PRIMCAR.®The excellent safety, efficacy, and persistence of the CAR-T cells produced by the platform are expected to bring a cure hope for SLE patients.
Autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, and antiphospholipid antibody syndrome, are the second largest disease category globally, only after cancer, and have always represented significant opportunities. In 2023, three out of the top ten best-selling drugs worldwide were for autoimmune diseases. According to data from Frost & Sullivan, by 2030, the global market size for autoimmune disease drugs is expected to reach $176 billion, while the market size in China is projected to reach $25 billion, becoming an important source of growth in the global autoimmune disease drug market.
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