Cartesian Therapeutics, Inc. (NASDAQ:RNAC) on Friday shared initial data from the ongoing Phase 2 open-label trial of Descartes-08, its lead cell therapy candidate, for systemic lupus erythematosus (SLE).
SLE is a chronic autoimmune disease where the body’s immune system attacks healthy tissues and organs, causing inflammation in various parts of the body, including joints, skin, kidneys, and the brain.
Initial data reported a significant reduction in disease activity following initial Descartes-08 treatment, with 100% of participants who reached Month 3 follow-up (n=3) achieving Lupus Low Disease Activity State response.
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Disease remission was seen in 2 out of 3 participants at Month 3.
Company Shifts Focus to Myasthenia Gravis and Myositis Programs
At this time, Cartesian plans to pause further development of Descartes-08 in SLE, including enrollment in the Phase 2 trial, to prioritize the opportunities in myasthenia gravis, currently in Phase 3, and myositis.
Cartesian announced the planned expansion of Descartes-08 into myositis.
The company plans to initiate an adaptive clinical trial design, which provides a potential opportunity for a single pivotal trial planned to commence in the first half of 2026.
The Phase 2 trial in myositis will assess Descartes-08 versus placebo administered as six weekly outpatient infusions without preconditioning chemotherapy in up to 50 patients with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome.
The company plans to file an investigational new drug application (IND) for this trial by the end of 2025.
Additional Trial Updates and Financial Outlook
The company also reported results from the Phase 1 dose escalation trial of outpatient administration of Descartes-15 in patients with multiple myeloma.
In this trial, no significant adverse events or dose-limiting toxicities were reported in any participants (n=3). The only Descartes-15-related adverse event was a grade 2 hypotension occurring after the first two infusions.
Cartesian plans to pause the development of Descartes-15 to prioritize opportunities for Descartes-08 in MG and myositis.
Following the pause in development of Descartes-15 in multiple myeloma and Descartes-08 in SLE, the company expects current cash resources to support planned operations through mid-2027.
Price Action: RNAC stock was trading higher by 4.91% to $7.585 at last check Friday.
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