August 13, 2024
eMedClub News
August 12, 2024, Nanjing, Shanghai, China, San Jose, California, USA — IASO Bio, a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative cell therapies, announced that the companyThe Investigational New Drug (IND) application for the self-developed fully human BCMA-targeted chimeric antigen receptor autologous T-cell injection (Icarus-lenalidomide injection) has received tacit approval from the U.S. Food and Drug Administration (FDA). It is intended for the treatment of non-renal Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN)., which is the fifth clinical approval that this product has received in the field of autoimmune diseases in both China and the United States.
Chief of IASO BioScienceOfficial
"We are pleased that the U.S. FDA has approved the IND for the two new indications, SLE and LN, further demonstrating the potential of Eque-cel as a therapeutic product for autoimmune diseases."
Clinical trial data in China has demonstrated the significant efficacy and safety of Eque-cel in treating relapsed/refractory self-antibody-mediated neurological diseases. We believe it will offer similar therapeutic potential for systemic lupus erythematosus (SLE), lupus nephritis (LN), and other autoimmune diseases where self-antibodies are a primary pathogenic factor. We will continue to fully advance the development of this innovative therapy to benefit more patients with autoimmune diseases in China and globally."
To date, IASO Bio's Equecabtagene Autoleucel Injection has received three IND approvals from the U.S. FDA for autoimmune disease indications, targeting Myasthenia Gravis (MG), Multiple Sclerosis (MS), and now Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN). In China, the product has also received two implied IND approvals from the National Medical Products Administration (NMPA) for autoimmune disease indications, targeting Neuromyelitis Optica Spectrum Disorder (NMOSD) and MG. Additionally, Equecabtagene Autoleucel Injection (brand name: Focuxin®) was approved by the NMPA in June 2023 for the treatment of adult patients with relapsed or refractory multiple myeloma who have progressed after at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent).
About Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disease and one of the earliest discovered human diseases associated with abnormal B lymphocyte subpopulations. The main symptoms in patients manifest as involvement of multiple systems and organs throughout the body, with a high presence of autoantibodies, and the natural course of the disease typically involves alternating periods of flare-ups and remission. Without timely treatment, irreversible damage to the affected organs can occur, ultimately leading to patient death. According to Frost & Sullivan, there were approximately 8.049 million SLE patients globally in 2023, including around 289,000 in the United States.
Regarding Lupus Nephritis (LN)
Lupus Nephritis (LN) is the most common severe complication of SLE, and studies have shown that 60% of SLE patients will develop LN during the course of their disease.[1], is the main reason for the high mortality rate in SLE patients. The current standard treatment regimen, while able to alleviate symptoms, cannot cure the disease, and as many as 14% to 33% of LN patients do not respond to treatment.[2,3]。
About IASO Bio's Equecabtagene Autoleucel Injection
Idecabtagene Vicleucel Injection is a personalized, gene-modified autologous T-cell immunotherapy (CAR-T) product targeting B-cell maturation antigen (BCMA), capable of recognizing and eliminating cells expressing BCMA. Based on an in-depth understanding of the pathogenic mechanisms of SLE, particularly the critical roles played by B cells and pathogenic antibodies in the disease, Idecabtagene Vicleucel utilizes second-generation CAR technology to precisely identify and eliminate BCMA-expressing B cells and plasma cells. This achieves the goal of clearing pathogenic cells and autoantibodies, suppressing autoimmune inflammation, and reducing disease activity.
IASO Bio is a biopharmaceutical company dedicated to the research, production, and commercialization of innovative cell-based drugs. With a focus on developing cellular therapies and antibody drugs for hematological malignancies as its innovation cornerstone, 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) in China and has received permission from the U.S. FDA to conduct registration clinical trials for the treatment of relapsed/refractory multiple myeloma.
IASO Bio, with its strong management team, innovative product pipeline, self-owned GMP manufacturing, and robust 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.com or LinkedIn account: www.linkedin.com/company/iasobiotherapeutics.
1. Saxena R, Mahajan T, Mohan C. Lupus nephritis: current update. Arthritis Res Ther. 2011;13(5):240.
2. Anders HJ, Hiepe F. Treatment options for refractory lupus nephritis. Clin J Am Soc Nephrol. 2019;14:653–655. [PubMed: 30979714]
3. Moroni G, Ponticelli C. The multifaceted aspects of refractory lupus nephritis. Expert Rev Clin Immunol. 2015;11:281–8. [PubMed: 25487410]
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