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Cartesian Initiates CAR-T Clinical Trial in Myasthenia Gravis

First CAR-T to enter clinical development for an autoimmune disease

Descartes-08 engineered to have a defined, predictable half-life, enabling repeat dosing to maximize potential for potency while minimizing risk of toxicity

Gaithersburg, MD, November 5, 2019 – Cartesian Therapeutics, a fully integrated, clinical-stage biopharmaceutical company developing cell and gene therapies for cancer and autoimmune diseases, today announced that it has initiated a Phase 1/2 clinical trial (NCT04146051) of its lead CAR-T candidate, Descartes-08, in patients with generalized myasthenia gravis (GMG).  To the company’s knowledge, the program is the first CAR-T investigational candidate to enter clinical development for an autoimmune disease.

“Patients with severe GMG have limited treatment options and are often dependent on nonselective, chronic immunosuppressive therapies (ISTs) that have long-term toxicities,” said Volkan Granit, MD, the trial’s principal investigator and Assistant Professor of Neurology at the University of Miami Miller School of Medicine. “Cartesian’s CAR-T technology selectively targets the primary culprit in the disease:  antibody-producing plasma cells.  Such selective targeting would be a first in GMG and could help patients discontinue use of chronic ISTs.”

“An increasing trend in the treatment of myasthenia gravis is the development of more targeted therapies,” said Michael Benatar, MD, PhD, Professor of Neurology, Chief of the Neuromuscular Division at the University of Miami Miller School of Medicine, and co-investigator on the study.  “The strategy of targeting for elimination the aberrant long-lived plasma cells that produce these autoantibodies with CAR-T cells is a novel and very promising approach.”

Descartes-08 is a CD8+ CAR-T investigational therapy that targets cells expressing B-cell Maturation Antigen (BCMA), a protein expressed by all plasma cells. “Unlike conventional CAR-T, which has the potential for uncontrolled proliferation and ensuing severe toxicity, Descartes-08 is engineered to have a defined and predictable half-life, enabling repeat dosing to maximize potency while minimizing risk of toxicity,” said Metin Kurtoglu, MD, PhD, Chief Medical Officer at Cartesian.  “Descartes-08’s enhanced safety features enable use for of a wide range of diseases, from multiple myeloma and other cancers to autoimmune diseases.”

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