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Cartesian Therapeutics Announces Positive Updated Results from Phase 2b Trial of Descartes-08 in Participants with Myasthenia Gravis and Outlines Design of Planned Phase 3 Trial
Phase 3 AURORA trial on track to commence in 1H2025; Primary endpoint to assess proportion of Descartes-08-treated participants with myasthenia gravis
About this update from Cartesian Therapeutics, Inc.
[{"type":"text","content":"Phase 3 AURORA trial on track to commence in 1H2025; Primary endpoint to assess proportion of Descartes-08-treated participants with myasthenia gravis demonstrating an MG-ADL improvement of ≥3 points at Month 4 relative to placebo Deepening responses observed over time in Phase 2b trial, with Descartes-08-treated participants observed to have a 5.5-point reduction in MG-ADL at Month 4 Durable responses observed through Month 12 in Phase 2b trial Safety profile consistent with previously reported data and continues to support outpatient administration Company to host conference call and webcast with key opinion leader today at 7:30 a.m. ET FREDERICK, Md., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced updated efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with generalized myasthenia gravis (MG) and provided details on the design of its planned Phase 3 AURORA trial. The updated data will be presented today at the 2nd Annual Cell Therapy for Autoimmune Disease Summit being held in Philadelphia. Descartes-08, Cartesian’s lead mRNA cell therapy candidate, is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T) product candidate targeting B-cell maturation antigen (BCMA). Descartes-08 is designed to be administered without preconditioning chemotherapy and does not use integrating vectors. Descartes-08 was previously granted Regenerative Medicine Advanced Therapy (RMAT) Designation and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of MG. “Current standards of care are associated with broad immunosuppression and limited efficacy, and patients with MG, which is a rare and incurable autoimmune disorder, are in dire need of new treatment options,” said James F. Howard Jr., M.D., Professor of Neurology, Medicine, and Allied Health at the University of North Carolina School of Medicine, and investigator in the Phase 2b trial. “These updated results continue to show deep responses durable for months after cessation of treatment in both heavily pre-treated participants and, notably, participants without prior exposure to biologic drugs, underscoring the potential for Descartes-08 to ...