First Patient Dosed in Phase 2 Trial of Descartes-08 for Systemic Lupus Erythematosus

GAITHERSBURG, Md., July 02, 2024 – Artesian Therapeutics, Inc. (the “Company”), a clinical-stage biotechnology firm known for pioneering mRNA cell therapy for autoimmune disorders, has announced the commencement of its Phase 2 open-label clinical trial. The trial will evaluate Descartes-08 in patients suffering from systemic lupus erythematosus (SLE).

Descartes-08, the company's premier mRNA cell therapy candidate, is a potential breakthrough mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T). This autologous mRNA CAR-T product targets B-cell maturation antigen (BCMA). Unlike traditional DNA-based CAR-T cell therapies, mRNA CAR-T does not require preconditioning chemotherapy and is not expected to pose the risk of genomic integration that could lead to cancerous transformations.

Previously, Descartes-08 was administered to patients in a Phase 2 clinical trial for myasthenia gravis (MG). The safety profile from this trial supports outpatient administration with minimal observation, a significant advancement in the field.

Carsten Brunn, Ph.D., President and CEO of Cartesian, emphasized the ongoing challenges faced by SLE patients despite recent treatment advancements. "Many patients still experience severe symptoms and disease progression," he stated. Brunn elaborated that Descartes-08 aims to address the limitations of conventional, costly DNA-engineered CAR-T cell therapies for autoimmune diseases. He expressed hope that Descartes-08 could offer a safer and more effective outpatient treatment option for SLE patients for whom existing therapies are insufficient.

Susan Manzi, M.D., M.P.H., Chair of the Medicine Institute at Allegheny Health Network and Medical Director for the Lupus Foundation of America, also expressed optimism. She described the dosing of the first patient with Cartesian’s mRNA CAR-T cell therapy as a significant achievement for the lupus patient community. Manzi highlighted the inadequacy of current treatment options for lupus patients and expressed hope that Descartes-08 would show early and sustained clinical benefits for those with B cell-mediated autoimmune diseases like lupus.

The Phase 2 open-label trial (NCT06038474) aims to enroll up to 30 adult patients and will evaluate the safety and tolerability of outpatient administration of Descartes-08 without preconditioning chemotherapy. Secondary measures will assess overall disease activity in patients with moderate or severe SLE who are refractory to immunosuppressant therapy.

About Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by systemic inflammation affecting multiple organ systems including the skin, joints, kidneys, brain, and heart. Its symptoms can range from mild to life-threatening, often including fatigue, joint pain, rash, and fever. Approximately 1.5 million people in the United States are affected by SLE.

About Cartesian Therapeutics

Cartesian Therapeutics is a clinical-stage biotechnology company that focuses on developing mRNA cell therapies to treat autoimmune diseases. The Company's leading candidate, Descartes-08, is a potential first-in-class mRNA CAR-T in Phase 2b clinical development for generalized myasthenia gravis and in Phase 2 development for systemic lupus erythematosus. A Phase 2 basket trial is planned for additional autoimmune indications. Cartesian’s clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T.

The company's ongoing efforts aim to unlock the full potential of Descartes-08 and advance its clinical trials to provide new treatment options for patients with autoimmune diseases. The commitment to innovation in mRNA cell therapies positions Cartesian Therapeutics at the forefront of addressing unmet medical needs in the autoimmune disease landscape.