IASO Biotherapeutics has secured US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for equecabtagene autoleucel (Eque-cel) aimed at two autoimmune disease indications.
The indications are non-renal systemic lupus erythematosus (SLE) and lupus nephritis (LN).
This is the fifth IND approval for Eque-cel in the treatment of autoimmune ailments across China and the US.
The therapy has previously been approved for myasthenia gravis (MG), multiple sclerosis (MS), and SLE/LN in the US, and for neuromyelitis optica spectrum disorder and MG in China.
In addition to these IND approvals, Eque-cel, also marketed as FUCASO, received marketing approval from China’s National Medical Products Administration in June 2023.
This approval allows the treatment of patients with relapsed and/or refractory multiple myeloma who have undergone at least three lines of prior therapies, including a proteasome inhibitor and an immunomodulatory agent.
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Eque-cel, a fully human anti-BCMA [B cell maturation antigen] CAR T cell injection, is a personalised immunotherapy that targets and eliminates BCMA-expressing cells.
It utilises second-generation CAR technology to address the pathological mechanisms of SLE, where B cells and pathogenic antibodies play a crucial role.
By targeting BCMA, the injection aims to remove activated B cells and plasma cells in SLE patients, reducing pathogenic cells and autoantibodies. This process suppresses autoimmune inflammation and alleviates the disease’s symptoms.
IASO Bio chief scientific officer Yongke Zhang stated: “We are delighted that the IND for the two new indications — SLE and LN — has been approved by the US FDA, further highlighting Eque-cel’s potential as a product for autoimmune diseases.
“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.”
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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