FDA approves IND application for Eque-cel T-cell therapy in SLE, lupus nephritis
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Key takeaways:
- The FDA has cleared an investigational new drug application for Eque-cel in patients with SLE and lupus nephritis.
- The autologous T-cell injection has now received three IND clearances from the FDA for autoimmune diseases.
The FDA has approved an investigational new drug application for Eque-cel, an autologous T-cell injection, in patients with systemic lupus erythematosus and lupus nephritis, according to a press release from the manufacturer.
Eque-cel (equecabtagene autoleucel, IASO Biotherapeutics), a fully human anti-BCMA autologous chimeric antigen receptor (CAR) T-cell therapy, has previously received IND-application clearances for the treatment of myasthenia gravis and multiple sclerosis. The FDA IND clearance allows for the drug to be administered in human trials.
“Clinical trial data from China have demonstrated Eque-cel’s significant efficacy and safety in treating relapsed/refractory autoantibody-mediated neurological diseases,” Yongke Zhang, MD, chief scientific officer at IASO, said in the release. “We believe it holds similar promise for other autoimmune diseases, such as SLE and lupus nephritis, 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.”
Equecabtagene autoleucel uses “second-generation CAR technology” to precisely eliminate BCMA-expressing B cells, resulting in suppressed inflammation and less disease, according to the press release.
In China, Eque-cel has received marketing approval for the treatment of patients with relapsed and/or refractory multiple myeloma who received at least three lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent.
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