Cartesian Begins Phase 3 Trial of New Cell Therapy for Myasthenia Gravis Without Chemo

Cartesian Therapeutics, Inc. (NASDAQ:RNAC) ("Cartesian" or the "Company"), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced that the first participant has been enrolled in its Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG).

Descartes-08, Cartesian's lead cell therapy candidate, is an autologous engineered chimeric antigen receptor T-cell therapy (CAR-T) product candidate targeting B-cell maturation antigen (BCMA). Descartes-08 is designed to be administered without preconditioning chemotherapy in an outpatient setting and does not use integrating vectors.

"With the first participant now successfully enrolled, commencement of our Phase 3 AURORA trial represents a significant milestone in our mission to deliver a differentiated, durable treatment option to patients with MG," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. "With sustained benefits observed through 12 months in our Phase 2b trial, we believe Descartes-08 has the potential to transform the current MG treatment paradigm with just a single course of therapy."

"Marked by chronic use of steroids and other immunosuppressants while often delivering only limited efficacy, the current standard of care for patients with MG is inadequate," said James (Chip) F. Howard, Jr., M.D., Cartesian Clinical Advisor and Professor of Neurology, Medicine, and Allied Health at the University of North Carolina School of Medicine. "Supported by compelling results from the Phase 2b trial, I firmly believe that Descartes-08 has the potential to serve as a safe, flexible, and durable treatment option for patients with MG. I look forward to helping advance this important study."

The Phase 3 AURORA trial is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 participants with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo.