- Cabaletta Bio Inc CABA has announced acute safety data from the first dose cohort of the ongoing DesCAARTes Phase 1 trial of DSG3-CAART for mucosal-dominant pemphigus Vulgaris (mPV).
- In the first cohort of three patients dosed with DSG3-CAART, there were no clinically relevant adverse events, including cytokine release syndrome or neurotoxicity, during the 8-day acute safety window.
- Additionally, no dose-limiting toxicities or clinically relevant adverse events were observed in the two patients who have completed more than the full 28-day DLT monitoring period post-infusion.
- These safety data were observed with an administered dose of 20 million DSG3-CAART cells, without preconditioning and in the presence of circulating anti-DSG3 antibodies.
- The third patient is scheduled to be evaluated for the presence of DSG3-CAART after the 28-day follow-up period.
- The trial currently enrolls patients in the second cohort at a treatment dose of 100 million DSG3-CAART cells.
- Acute safety data for the second and third cohorts are expected in the third and fourth quarters of 2021, respectively.
- Topline data on target engagement from the first cohort are anticipated during the second half of 2021.
- The company also reported Q1 2021 fiscal results with an EPS loss of $0.41 higher than $0.33 a year ago.
- Cash and equivalents of $102.0 million are expected to fund its operating plan through at least the fourth quarter of 2022.
- Price Action: CABA shares are down 0.04% at $11.13 in the market trading session on the last check Monday.
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