About

Our Story

Since Cabaletta Bio was founded in 2017, we have been working toward a singular goal: Developing and launching the first curative targeted cellular therapies for patients with autoimmune diseases.

Over the past five years, our robust track record of execution has yielded two clinical-stage programs that are elegantly designed to target only the cells responsible for disease. We are encouraged by the safety profile demonstrated by our DSG3-CAART in the DesCAARTes™ Phase 1 trial to date, and based on emerging translational data, we are employing combination strategies to increase DSG3-CAART cell activity. As our next CAART candidate, MuSK-CAART for patients with MuSK-associated myasthenia gravis, prepares to enter the clinic, we are employing our deep understanding of CAART therapy to accelerate the potential to observe signs of clinical efficacy, including a higher starting cell dose delivered as a single infusion, smaller patient cohorts and earlier implementation of combination strategies. Our robust clinical execution is demonstrated through our positive regulatory interactions since 2018, with two IND applications cleared within the routine 30-day period, implementation of multiple clinical trial protocol modifications, two Fast Track Designations and two Orphan Drug Designations granted to pipeline candidates, as well as our successful manufacturing of novel cell therapy products with academic and industry partners. 

As we have established our position in the field of autoimmunity, we continue to evaluate novel approaches that have the potential to cure autoimmune diseases. We were excited to see the breakthrough results generated by Professor Georg Schett, M.D. and his colleagues at Friedrich-Alexander-Universität Erlangen-Nürnberg, published in Nature Medicine in September 2022, showing the potential for CD19-CAR T to transform the course of systemic lupus erythematosus (SLE). In five patients with SLE, one-time treatment with a 4-1BB-containing CD19-CAR T cell therapy induced deep and durable clinical responses in all five patients within three months after treatment, with favorable tolerability. Healthy B cells repopulated in all patients within five months of treatment, and responses remained durable with up to 17 months of follow-up. These findings demonstrate the potential for CD19-CAR T to “reset the immune system,” eliminating the cause of autoimmune disease with restoration of the healthy immune system.

Building on these results, we have initiated development of CABA-201, a 4-1BB-containing CD19-CAR T therapy, for the treatment of severe autoimmune diseases. We are employing a fully human CD19 binder that has high similarity to the construct employed in the academic study, and through an exclusive translational research partnership with Professor Schett, we will employ our robust translational engine to generate early and actionable insights from his trials that may inform our clinical development.

Accelerated by our team’s deep expertise in cell therapy, robust clinical experience in autoimmunity, and demonstrated track record of strong execution, we are uniquely positioned to employ CD19-targeting strategies in order to further our mission to develop therapies that deliver deep, durable and potentially curative responses for patients with autoimmune diseases.