Cartesian Therapeutics, an mRNA cell therapy biotech, said its lead investigational medicine helped patients with an autoimmune condition that has caught the attention of many biopharmas in recent years.
The Maryland-based biotech, which recently went public through a reverse merger with Selecta Biosciences, said that its experimental therapy Descartes-08 met the primary endpoint in a Phase 2b study for the nerve communication-destroying disease myasthenia gravis. It helped 71% of patients achieve a 5-point or greater improvement on a 60-point scale of the disease. That compared to 25% of patients who received placebo, with a p-value of 0.018, Cartesian said Tuesday morning.
Researchers looked at data from 26 patients, and the company plans to meet with US regulators before year’s end for an end-of-Phase 2 meeting.
The data come days after Johnson & Johnson said it would submit its own myasthenia gravis drug, nipocalimab, for approval by the end of 2024 as it hopes to follow argenx, AstraZeneca and UCB. Multiple other biopharmas are looking to get into the field, including Amgen, Immunovant, Biohaven, Dianthus and others.
Cartesian is one of multiple cell therapy biotechs that have joined the burgeoning autoimmune field. The biotech believes it could have an advantage with its mRNA CAR-T directed therapy because it doesn’t require lymphodepleting chemotherapy and can be administered in an outpatient setting.
“We believe the positive data presented today demonstrate clinical proof-of-concept of our novel mRNA platform and highlight the potential of Descartes-08 to provide deep and durable improvements for patients with MG,” CEO Carsten Brunn said in a press release.
Meanwhile, Cartesian said it has started a Phase 2 study of the same cell therapy in patients with systemic lupus erythematosus, or SLE. It also raised $130 million via a PIPE from HBM Healthcare Investments, Invus, Schooner Capital, Surveyor Capital and famed researcher and entrepreneur Tim Springer, among other backers.
Cartesian’s share price $RNAC fell about 11% in early trading before Tuesday’s opening bell.
In addition, Cartesian appointed Kemal Malik to its board. The former longtime Bayer executive is also on the board of UK investor and incubator Syncona.