Cartesian Therapeutics, Inc. (NASDAQ: RNAC) has announced positive updated results from the phase 2b trial of Descartes-08 in participants with generalized myasthenia gravis (MG). The trial showed deepening responses over time, with Descartes-08-treated participants experiencing a 5.5-point reduction in MG-ADL at month 4. Notably, participants without prior exposure to biologic therapies demonstrated particularly deep responses, with an average MG-ADL reduction of 6.6 at month 4. Responses were observed to further deepen at month 6, with 33% of participants in the primary efficacy dataset and 57% of participants with no prior exposure to biologic therapy observed to have minimum symptom expression.
The safety profile of Descartes-08 was consistent with previously reported data, with no cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) observed. The company has outlined the design of its planned phase 3 Aurora trial, which is on track to commence in the first half of 2025. The trial will assess Descartes-08 versus placebo in approximately 100 participants with acetylcholine receptor autoantibody positive (AChR Ab+) MG.
In addition, Cartesian provided positive updated results from retreated participants enrolled in the phase 2a open-label portion of the trial. Two participants who were previously retreated experienced rapid improvement in clinical scores and maintained minimum symptom expression for up to one year after receiving a second treatment cycle. Four of the seven remaining participants from the phase 2a portion of the trial maintained clinically meaningful responses for at least one year following initial dosing.
The company will host a conference call and webcast to discuss the updated data and the design of its planned phase 3 trial. Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapies for the treatment of autoimmune diseases, with Descartes-08 being its lead mRNA cell therapy candidate. Following these announcements, the company's shares moved -0.2%, and are now trading at a price of $19.54. Check out the company's full 8-K submission here.
