FDA grants rare pediatric status for Cartesian’s Descartes-08

US clinical-stage biotech Cartesian Therapeutics (Nasdaq: RNAC) today announced that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM).

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.

“We are pleased that the FDA recognizes the potential of Descartes-08 to serve as a meaningful therapeutic option for this underserved pediatric patient population,” said Carsten Brunn, president and chief executive of Cartesian. “Leveraging our novel mRNA platform, we are committed to our mission of expanding the reach of cell therapy to patients with autoimmune diseases. We remain on track to file an Investigational New Drug application for a Phase II pediatric basket study focused on neurology and rheumatology autoimmune indications, including JDM, by year-end.”