Cabaletta Bio's Updated Interim DSG3-CAART Data Fails To Cheer Investors

  • Cabaletta Bio Inc CABA presented updated data from the DesCAARTes trial, evaluating DSG3-CAART in adults with mucosal-dominant pemphigus vulgaris (mPV), a blistering skin disease that affects mucous membranes.
  • No dose-limiting toxicities were observed within three months of DSG3-CAART infusion through cohort A4 (2.5 billion cells).
  • There was a dose-dependent increase in DSG3-CAART persistence through day 29 in cohorts A1 to A4, indicating that DSG3-CAART cells were not eliminated through immune-mediated rejection.
  • Also See: Cabaletta Bio's Cell Therapy Fails To Show Activity At Low Doses In Skin Blistering Disorder.
  • In cohorts A1 to A3: Disease activity was clear or almost clear (PDAI 0-1) in 0/9 subjects at screening, 1/9 at pre-infusion, 2/9 at month one, 5/9 at month two, 3/9 at month three, 2/9 at month four, 3/9 at month five and 1/9 at month six after treatment.
  • These data suggest that DSG3-CAART cells are not being eliminated by the pre-existing anti-DSG3 immunity present in mPV.
  • The trial is currently in cohort A5 (5.0 to 7.5 billion cells). The Company plans to include two new additional dose cohorts – A5e (enhanced manufacturing process at 5.0 to 7.5 billion cells) and A6m (multi-dose regimen at 10 to 15 billion cells). 
  • Price Action: CABA shares are down 15.4% at $1.59 during the market session on the last check Wednesday.
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