Cartesian Therapeutics, Inc. (United States)

Cartesian Therapeutics plans to launch a Phase 3 trial of Descartes-08, its experimental CAR T-cell therapy for myasthenia gravis (MG), in 2025. Descartes-08 aims to reduce MG severity by targeting antibody-producing B-cells using messenger RNA, avoiding chemotherapy. Positive Phase 2b data showed 71% of patients experienced meaningful disease severity reduction and lower antibody levels, with a favorable safety profile.

Cartesian Therapeutics granted inducement awards to five new employees, issuing options for 60,961 shares of common stock with a $17.11 exercise price, vesting over four years.

Descartes-08, an mRNA CAR-T therapy, showed 71% of myasthenia gravis patients had a clinically meaningful MGC score improvement at Month 3, compared to 25% for placebo. The therapy demonstrated deep and durable responses up to six months, with a favorable safety profile supporting outpatient administration. Cartesian plans to hold an End-of-Phase 2 meeting with the FDA by year-end.

Cartesian Therapeutics initiates Phase 2 trial of Descartes-08, an mRNA CAR-T therapy for SLE, aiming to provide an outpatient treatment without lymphodepleting chemotherapy.

Amgen's Phase 3 results for rocatinlimab in atopic dermatitis and Uplizna in myasthenia gravis were met with skepticism by analysts, who noted rocatinlimab's underwhelming efficacy and safety concerns, while Uplizna's potential as a second-line treatment was seen as sizable but not a threat to market leaders.

Ractigen Therapeutics receives FDA orphan drug designation for RAG-18, a saRNA for DMD/Becker muscular dystrophy. Biogen's nusinersen shows higher dose efficacy in SMA. Cartesian Therapeutics initiates Descartes-15 CAR-T phase 1 trial for r/r multiple myeloma. Imugene's azer-cel CAR-T produces complete responses in r/r diffuse large B cell lymphoma. Novartis licenses Voyager Therapeutics' capsid for neurological target. BridgeBio Pharma's BBP-812 receives FDA RMAT designation for Canavan disease. Genprex plans to spin off its diabetes program into NewCo. NCI awards TransCode $2 million for TTX-MC138 RNA therapy in advanced solid tumors.

Cartesian Therapeutics receives Rare Pediatric Disease Designation for Descartes-08, its mRNA CAR-T therapy for juvenile dermatomyositis. The company plans to file an IND for a Phase 2 pediatric basket study by year-end.

Cartesian Therapeutics receives FDA Rare Pediatric Disease Designation for Descartes-08, an mRNA CAR-T therapy for juvenile dermatomyositis (JDM), with plans to file an Investigational New Drug application for a Phase 2 pediatric study by year-end.

Cartesian Therapeutics' Descartes-08, an autologous BCMA-directed mRNA CAR-T therapy, showed deep remission in MG patients up to 12 months post-treatment at the ASGCT 27th Annual Meeting. The therapy, administered without lymphodepletion chemotherapy in an outpatient setting, demonstrated a strong safety profile with no cytokine release syndrome or neurotoxicity. Challenges included integrating different medical teams and COVID-19 affecting enrollment. Future plans include trials for systemic lupus and other autoimmune diseases, with an ongoing double-blind placebo-controlled trial in MG.