The U.S. Food and Drug Administration (FDA) has granted fast track designation to CAR T-cell therapy ADI-001 as a potential treatment for lupus nephritis, a lupus complication marked by kidney damage and inflammation. The FDA gives fast track status to experimental treatments that have the potential to fill unmet…
GRI Bio announced what it called “encouraging preclinical data” on two systemic lupus erythematosus (SLE) treatment candidates. SLE is the most common form of lupus. GRI-0124, an oral small molecule being developed to activate natural killer T-cells, or NKT cells, and keep autoimmune attacks in check eased inflammation…
A dual-target CAR T-cell therapy from iCell Gene Therapeutics safely led to medication-free disease remission for systemic lupus erythematosus (SLE) patients in a small Phase 1 study. For patients with lupus nephritis (LN), a common and serious SLE manifestation involving the kidneys, renal function also was improved. Based…
The U.S. Food and Drug Administration (FDA) has approved the use of Benlysta (belimumab) in a prefilled autoinjector as an add-on treatment for children ages 5 and older with systemic lupus erythematosus (SLE), the most common form of lupus. This is the first time children with active disease…
Different combinations and elevated levels of antiviral immune signaling proteins, called interferons (IFNs), were associated with differences in the symptoms and severity of systemic lupus erythematosus (SLE), a study shows. While IFNs are known to play a role in the disease, increases in IFN levels don ‘t explain many…
A 27-year-old woman with hard-to-treat systemic lupus erythematosus (SLE), the most common type of lupus, became the first patient treated in an early clinical trial evaluating FT819, Fate Therapeutics’ off-the-shelf CAR T-cell therapy candidate. The Phase 1 study (NCT06308978), taking place at the University of Minnesota Medical…
Inflammatory macrophages, a type of immune cell tasked with clearing the body of harmful invaders and dead cells, may be linked to more severe lupus nephritis in children with systemic lupus erythematosus, a small study suggests. Those immune cells, called M1-like macrophages, appear to play a more important role…
About 91% of lupus patients report they are currently taking or had been using oral steroids to manage their symptoms, according to a global survey of more than 7,700 patients. The World Lupus Federation (WLF) released findings from the survey ahead of World Lupus Day, observed…
The U.S. Food and Drug Administration (FDA) has updated the prescribing label for Lupkynis (voclosporin), which is approved to treat a severe manifestation of lupus called lupus nephritis, to include data that shows it continues to safely preserve kidney function for up to three years. The data came…
Note: This story was updated May 6, 2024, to correct that Cullinan Therapeutics continues to pursue its oncology platform while also expanding into treatments for autoimmune diseases including lupus. Cullinan Therapeutics has announced its plans to exclusively pursue the development of its T-cell-engager CLN-978 as a treatment for…