IASO Bio's CAR-T Therapy Eque-cel Receives FDA IND Clearance for Two New Autoimmune Indications: Systemic Lupus Erythematosus and Lupus Nephritis
IASO Biotechnology
Cancer Treatment New Drug Developer
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-lentuximab autoleucel 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.
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 obtained two implied IND approvals from the National Medical Products Administration (NMPA) for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) and MG. Meanwhile, Equecabtagene Autoleucel Injection (Foleucin)®) has been approved by the National Medical Products Administration 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).
References:
