IASO Bio Receives U.S. FDA Approval of Investigational New Drug Application for Equecabtagene Autoleucel for Two New Autoimmune Disease Indications

SHANGHAI, NANJING, China and SAN JOSE, Calif., Aug. 12, 2024 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), 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.

About Systemic Lupus Erythematosus (SLE)

SLE is a systemic autoimmune disease and is one of the earliest discovered human autoimmune diseases related to the abnormalities of the B lymphocyte subpopulation. The main symptoms of patients are characterized by involvement of multiple systems and organs throughout the body, with a large amount of autoantibodies present in the body, and the natural course of the disease is mostly an alternation of exacerbation and remission. If not treated in time, it can cause irreversible damage to the affected organs, ultimately leading to the death of the patient. According to Frost & Sullivan, there were about 8.049 million SLE patients worldwide in 2023, including 289,000 in the United States.

About 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], making it a major cause of high mortality in SLE patients. Current standard-of-care treatments for SLE have limited efficacy, with 14%–33% of LN patients showing no response to treatment^[2,3]。

About Equecabtagene Autoleucel

Equecabtagene Autoleucel is an individually tailored, BCMA-targeted genetically modified autologous T cell immunotherapy product that identifies and eliminates BCMA-expressing cells. Based on the understanding of the pathological mechanisms of SLE, particularly the pivotal role played by B cells and pathogenic antibodies in the disease, Equecabtagene Autoleucel employs second-generation CAR technology to precisely identify and eliminate cells expressing BCMA. By clearing the activated B cells and plasma cells from the body of the SLE patients, it reduces the pathogenic cells and  autoantibodies, thereby suppressing autoimmune inflammation and alleviate the disease.

About IASO Bio

IASO Bio is a biopharmaceutical company focused on the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercialization.

Its pipeline includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received Biologics License Application (BLA) approval from China's National Medical Products Administration (NMPA) in June 2023and U.S. FDA IND approval for the treatment of R/RMM in December 2022.

Leveraging its strong management team, innovative product pipeline, as well as integrated and high quality manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China and around the world. For more information, please visit http://www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics.