Cabaletta Bio's Cell Therapy In Skin Blistering Disorder Shows Favorable Safety Profile
Cabaletta Bio's Cell Therapy In Skin Blistering Disorder Shows Favorable Safety Profile
* Cabaletta Bio Inc (NASDAQ: 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.
* Cabaletta Bio Inc (NASDAQ: 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.