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Cartesian Therapeutics Announces Presentation of Results from Phase 2b Trial of Descartes-08 in Patients with Myasthenia Gravis at the 2024 MGFA Scientific Session of the AANEM Annual Meeting
Company continues to expect to hold an End-of-Phase 2 meeting with the FDA by year-end GAITHERSBURG, Md., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Cartesian
About this update from Cartesian Therapeutics, Inc.
[{"type":"text","content":"Company continues to expect to hold an End-of-Phase 2 meeting with the FDA by year-end\nGAITHERSBURG, Md., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced the presentation of data from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG) during the 2024 Myasthenia Gravis Foundation of America (MGFA) Scientific Session of the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting being held today in Savannah, Georgia. Positive topline results from the trial were previously announced in July 2024. A copy of today’s presentation will be available in the Publications and Presentations section of the Company’s website. 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. “Descartes-08 has strong potential for deep and durable improvements in patients with MG treated in the convenient outpatient setting without preconditioning chemotherapy and with no observed-to-date increased risk of infection,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “We look forward to continuing to collaborate with the FDA to determine next steps for the Descartes-08 program for MG and plan to hold an End-of-Phase 2 meeting by the end of this year. We are steadfast in our commitment to advancing our pipeline of innovative mRNA cell therapy candidates to extend the reach of this powerful modality to patients with autoimmune conditions.” Trial Overview and Topline Results In the Phase 2b double-blind, placebo-controlled, crossover trial, a total of 36 heavily pre-treated, highly symptomatic patients with MG were randomized 1:1 to receive either Descartes-08 or placebo administered as six weekly outpatient infusions without preconditioning chemo...