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 from AURORA 2 (NCT03597464), a two-year extension to the one-year Phase 3 AURORA 1 trial (NCT03021499) that looked at how safe Lupkynis is and how well it works in adults with lupus nephritis when given on top of mycophenolate mofetil (MMF) and low-dose corticosteroids. After three years, more pat ..read more

Cullinan Therapeutics has announced its plans to exclusively pursue the development of its T-cell-engager CLN-978 as a treatment for autoimmune disorders, beginning with systemic lupus erythematosus (SLE). The goal, according to the company, is to transform CLN-978 into a safe, first-in-class disease-modifying therapy. The Massachusetts-based biopharmaceutical, formerly known as Cullinan Oncology, intends to submit an investigational new drug application to the U.S. Food and Drug Administration (FDA) later this year seeking authorization to test CLN-978 in patients with SLE, the most common f ..read more

For this Lupus Awareness Month, marked each May, the focus is on educating people about the autoimmune disorder thought to affect about 1.5 million U.S. residents and more than 5 million individuals globally. World Lupus Day, bringing disease warriors worldwide together, will be observed on May 10. In addition to the general public, the event is aimed at lawmakers, industry representatives, public authorities, health professionals, and scientists. Recommended Reading March 6, 2024 by Candace J. Semien How an afternoon tea led me to my rare disease communities Supporters asked to wear pu ..read more

The first patient has been dosed in the U.S. as part of a clinical trial testing AlloNK, an experimental natural killer (NK) cell therapy candidate, in patients with lupus nephritis, one of the most common and severe complications of lupus. The open-label Phase 1 trial (NCT06265220) is running as a collaboration between Lupus Therapeutics and Artiva Biotherapeutics, and will test the safety and efficacy of AlloNK in adults whose lupus nephritis has returned or didn’t respond to standard-of-care treatments. Artiva said participants will receive AlloNK in combination with rituximab (sold as Rit ..read more

The U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is joining the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to focus on CAR T-cell treatments and other engineered cell therapies, a promising new therapeutic field now being explored for lupus. “We are delighted to have the Center for Biologics Evaluation and Research join Lupus ABC at this important juncture in the development of engineered cell therapies for lupus to help us accelerate their clinical evaluation,” Teodora Staeva, PhD, vice president and chief scientific officer of th ..read more

Depression is highly prevalent among people with systemic lupus erythematosus (SLE), but often goes undiagnosed, according to a single center study in Pakistan. The “treatment of depression is a vital component in the management of these patients and should be offered where appropriate,” the researchers wrote in “Undiagnosed Depression and Its Effects on Patients With Systemic Lupus Erythematosus,” which also found the intensity of depression was associated with SLE disease activity and severity. The study was published in Cureus. SLE is the most common form of lupus. People with lupus a ..read more

The U.S. Food and Drug Administration (FDA) has cleared a clinical trial to evaluate the safety and preliminary effectiveness of CB-010, Caribou Biosciences’ investigational CAR T-cell therapy, for lupus that affects the kidneys and other organs. The multicenter Phase 1 trial, dubbed GALLOP, should begin by the end of the year, according to the company. CB-010 is being developed for people with lupus nephritis, the most common complication of lupus that’s marked by kidney damage and inflammation, along with extrarenal lupus, where other organs are affected. Immune B-cells, which normally prod ..read more

Treatment with the investigational injection therapy itolizumab significantly reduced urine protein levels, a marker of kidney dysfunction, in people with active lupus nephritis, a serious lupus complication marked by kidney damage and inflammation. That’s according to top-line results from a Phase 1b trial called EQUALISE (NCT04128579) that were recently announced by the therapy’s developer, Equillium. “Physicians want to rapidly and safely reduce the levels of proteinuria [urine protein levels] in patients with lupus nephritis, as this has been associated with improved long-term outcomes, s ..read more

FibroBiologics, a biopharmaceutical company that seeks to develop and commercialize fibroblast cell-based therapies, has filed an application with the United States Patent and Trademark Office covering the use of its technology to potentially treat lupus. Using its proprietary fibroblast platform, the Houston-based company aims to develop cures and treatments for a number of chronic conditions, including lupus. “Our scientists continue to explore clinical opportunities to treat chronic diseases using fibroblast cells, which are natural immune modulators,” Pete O’Heeron, FibroBiologics’ founde ..read more

The U.S. Food and Drug Administration (FDA) has approved a clinical trial to evaluate the safety and effectiveness of Synthekine‘s two-component immunotherapy for the treatment of certain patients with lupus, without using lymphodepletion, a process in which chemotherapy is used beforehand to eliminate disease-causing immune cells. The multicenter, dose escalation Phase 1 clinical trial will assess the safety and effectiveness of SYNCAR-001 plus STK-009 in systemic lupus erythematosus (SLE) patients without kidney involvement, as well as in those with lupus nephritis, a lupus complicatio ..read more