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US FDA Grants Rare Paediatric Disease Designation to Cartesian Therapeutics’ Descartes-08

11 Sep 2024
Admin
News Article

US FDA Grants Rare Paediatric Disease Designation to Cartesian Therapeutics’ Descartes-08

US FDA grants rare paediatric disease designation to Cartesian Therapeutics’ Descartes-08 to treat juvenile dermatomyositis

Overview

Cartesian Therapeutics, Inc., a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, announced that the US Food and Drug Administration (FDA) has granted Rare Paediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM).

About Descartes-08

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.

Words from CEO: Cartesian

“We are pleased that the FDA recognizes the potential of Descartes-08 to serve as a meaningful therapeutic option for this underserved paediatric patient population,” said Carsten Brunn, Ph.D., president and chief executive officer 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 2 paediatric basket study focused on neurology and rheumatology autoimmune indications, including JDM, by year-end.”

RPD Disease

The FDA grants Rare Paediatric Disease Designation for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the United States.
Under the FDA’s Rare Pediatric Disease Designation and Voucher Programme, if Decartes-08 is approved for marketing in JDM, Cartesian may qualify for a priority review voucher that can be redeemed to receive priority review of a subsequent marketing application for a different product.

About Juvenile Dermatomyositis

Juvenile Dermatomyositis (JDM) is a rare paediatric autoimmune disorder marked by pathognomonic skin rash and muscle inflammation affecting multiple organ systems including the joints, heart, lungs, kidneys, eyes, and gastrointestinal systems.
The symptoms of JDM can range from mild to life-threatening and symptoms often include fatigue, joint pain, muscle weakness and fever.
JDM impacts approximately 4,000 people in the United States.

Cartesian Therapeutics

Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapies for the treatment of autoimmune diseases.
The company’s lead asset, Descartes-08, is an mRNA CAR-T in Phase 2b clinical development for patients with generalized myasthenia gravis and phase 2 development for systematic lupus erythematosus, with a phase 2 basket trial planned in additional autoimmune indications.