IASO Bio Gets FDA Nod for Equecabtagene Autoleucel in Two New Autoimmune Diseases

IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on innovative cell therapy and antibody products, has announced that its investigational new drug (IND) application for Equecabtagene Autoleucel (Eque-cel) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of Non-renal Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN). This milestone marks the fifth IND approval for Eque-cel for autoimmune diseases in both China and the United States.

Dr. Yongke Zhang, Chief Scientific Officer of IASO Bio, expressed excitement over the approval, emphasizing Eque-cel’s potential for treating autoimmune diseases. Clinical trial data from China have shown significant efficacy and safety of Eque-cel in treating relapsed/refractory autoantibody-mediated neurological diseases, and similar promise is expected for SLE and LN. Dr. Zhang highlighted the eagerness to expedite the development of this innovative therapy to benefit more patients globally.

To date, Eque-cel has received three IND approvals from the U.S. FDA for autoimmune indications, including Myasthenia Gravis (MG), Multiple Sclerosis (MS), and now SLE/LN. In China, the product has also garnered two IND approvals from the National Medical Products Administration (NMPA) for Neuromyelitis Optica Spectrum Disorder (NMOSD) and MG. Furthermore, Eque-cel, marketed as FUCASO®, received marketing approval from the NMPA in June 2023 for treating patients with relapsed and/or refractory Multiple Myeloma (R/RMM) who have undergone at least three lines of prior therapies.

Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disease that involves multiple systems and organs, with a significant presence of autoantibodies. The disease course typically alternates between exacerbation and remission, and if untreated, can lead to irreversible organ damage and potentially death. As of 2023, there were approximately 8.049 million SLE patients worldwide, including 289,000 in the United States.

Lupus Nephritis (LN) is a severe complication of SLE, affecting about 60% of SLE patients during their disease course, making it a leading cause of high mortality among SLE patients. Current treatments for SLE have limited efficacy, with a considerable percentage of LN patients showing no response to standard-of-care treatments.

Equecabtagene Autoleucel is a personalized, BCMA-targeted genetically modified autologous T cell immunotherapy product that identifies and eradicates BCMA-expressing cells. It uses second-generation CAR technology to accurately target and eliminate cells expressing BCMA, thus reducing pathogenic cells and autoantibodies. This mechanism helps in suppressing autoimmune inflammation and alleviating disease symptoms in SLE patients.

IASO Bio is a biopharmaceutical company specializing in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. The company covers the entire drug development process from early discovery to clinical development, regulatory approval, and commercialization. Its product pipeline includes over 10 novel products, with Equecabtagene Autoleucel (a fully human BCMA CAR-T injection) being a key component. Equecabtagene Autoleucel received Biologics License Application (BLA) approval from China's NMPA in June 2023 and U.S. FDA IND approval for treating R/RMM in December 2022.

IASO Bio aims to deliver transformative and affordable therapies to meet unmet medical needs, leveraging its strong management team, innovative product pipeline, and integrated manufacturing and clinical capabilities. The company is focused on making a significant impact on patients' lives in China and globally.