Business
Cartesian Therapeutics Announces Positive Topline Results from Phase 2b Trial of Descartes-08 in Patients with Myasthenia Gravis
Trial met primary endpoint with statistical significance, with 71% of myasthenia gravis patients treated with Descartes-08 observed to have a clinically
About this update from Cartesian Therapeutics, Inc.
[{"type":"text","content":"Trial met primary endpoint with statistical significance, with 71% of myasthenia gravis patients treated with Descartes-08 observed to have a clinically meaningful improvement in MGC score at Month 3 compared to 25% for placebo Deep and durable responses up to at least six months observed in patients treated with Descartes-08 Safety profile continues to support outpatient administration Company expects to hold End-of-Phase 2 meeting with the FDA by year-end Company to host conference call today at 8:00 a.m. ET GAITHERSBURG, Md., July 02, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“Cartesian” or the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced positive topline results from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG). Descartes-08, Cartesian’s lead product candidate, is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T) directed against the B cell maturation antigen (BCMA). It is designed to be administered as an outpatient treatment without the need for lymphodepleting chemotherapy required to achieve activity with conventional CAR-T cell therapies. 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. “We believe the positive data presented today demonstrate clinical proof-of-concept of our novel mRNA platform and highlight the potential of Descartes-08 to provide deep and durable improvements for patients with MG,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Our recently granted RMAT designation supports the continued development of Descartes-08 in collaboration with the FDA, with plans to hold an End-of-Phase 2 meeting by the end of the year. The results also exemplify what we hope to obtain with other assets in our existing and future pipeline.” “MG is a devastating, rare autoimmune disorder with high unmet need for short-course treatments. The current standard of care, chronic use of steroids and other immunosuppressants, is often associated with broad immunosuppression and limited efficacy,” said Tahseen Mozaffar, M.D., Professor of Neurology, Pathology and Laboratory Medicin...