Cabaletta Bio's Cell Therapy Fails To Show Activity At Low Doses In Skin Blistering Disorder

Cabaletta Bio Inc's CABA DSG3-CAART fails to show biologic activity to date in the two lowest cell dose cohorts of Phase 1 trial mucosal Pemphigus Vulgaris (mPV).

• In cohort A1 (20 million DSG3-CAART cells), two of three participants had DSG3 autoantibody levels that rose over 20%, along with disease activity scores that worsened within six months after DSG3-CAART infusion.
• In cohort A2 (100 million DSG3-CAART cells), two of three participants maintained stable DSG3 autoantibody levels through four months. 
• One of these patients maintained stable disease activity scores through the six-month follow-up, while the other patient maintained stable scores initially before subsequently worsening. 
• DSG3-CAART persistence was not observed above the assay's threshold for quantification at three months post-infusion.
• The first additional cohort in the dose-escalation phase of the DesCAARTes trial is anticipated to be the A5 cohort. Patients will receive between 5.0-7.5 billion DSG3-CAART cells. 
• Dosing is underway in the fourth cohort at a dose of 2.5 billion DSG3-CAART cells. 
• The Company anticipates topline biologic activity from the 500 million cell cohort A3 and 28-day safety data from the 2.5 billion cell cohort in Q1 2022.
• Related Link: Cabaletta Posts Cell Therapy Data From Third Cohort Of Autoimmune Skin Disorder Trial.
• Price Action: CABA shares are down 71.40% at $3.58 during the market session on the last check Tuesday.