NEW YORK – The US Food and Drug Administration has granted Iaso Biotherapeutics permission to begin clinical trials of its autologous BCMA-targeted CAR T-cell therapy equecabtagene autoleucel (eque-cel) in two new autoimmune diseases, the biopharma company said this week.
Nanjing, China-based Iaso Bio plans to begin testing eque-cel in patients with non-renal systemic lupus erythematosus (SLE) and lupus nephritis (LN).
"Clinical trial data from China have demonstrated eque-cel's significant efficacy and safety in treating relapsed/refractory autoantibody-mediated neurological diseases," Iaso Bio CSO Yongke Zhang said in a statement. "We believe it holds similar promise for other autoimmune diseases, such as SLE and LN, where autoantibodies play key pathogenic roles."
In China, eque-cel, branded as Fucaso, received marketing approval from the National Medical Products Administration last year as a treatment for certain patients with relapsed and/or refractory multiple myeloma. The firm has also received permission to clinically test eque-cel in two autoimmune indications: neuromyelitis optica spectrum disorder and myasthenia gravis.
In the US, the FDA has also approved investigational new drug (IND) applications allowing the company to test the cell therapy in myasthenia gravis and multiple sclerosis.