IASO Bio Gains U.S. FDA Approval for Investigational New Drug Application of Equecabtagene Autoleucel for Two New Autoimmune Disease Indications
Monday, August 12, 2024
IASO Biotherapeutics, a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing innovative cell therapy and antibody products, today announced that the investigational new drug (IND) application for its fully human anti-BCMA chimeric antigen receptor autologous T cell injection (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 is the fifth IND approval obtained for Eque-cel for autoimmune diseases in China and the United States.
"We are delighted that the IND for the two new indications—SLE and LN—has been approved by the U.S. FDA, further highlighting Eque-cel's potential as a product for autoimmune diseases," said Yongke Zhang, M.D., Chief Scientific Officer of IASO Bio. "Clinical trial data from China have demonstrated Eque-cel's significant efficacy and safety in treating relapsed/refractory autoantibody-mediated neurological diseases. We believe it holds similar promise for other autoimmune diseases, such as SLE and LN, where autoantibodies play key pathogenic roles. We are eager to accelerate this innovative therapy to benefit more patients with autoimmune diseases in China and globally."
To date, Eque-cel has received three IND approvals from the U.S. FDA for autoimmune indications, including the treatment of Myasthenia Gravis (MG), Multiple Sclerosis (MS), and SLE/LN. In China, the product has also received two IND approvals from the National Medical Products Administration (NMPA) for autoimmune indications Neuromyelitis Optica Spectrum Disorder (NMOSD) and MG. Additionally, Eque-cel (FUCASO®) received marketing approval by the NMPA in June 2023 for the treatment of patients with relapsed and/or refractory Multiple Myeloma (R/RMM) who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent.
Source: prnewswire.com
