Cabaletta Bio Reports Acute Safety Data from the First Dose Cohort in DesCAARTes™ Trial
– No dose limiting toxicities (DLTs) or clinically relevant adverse events observed in the first dose cohort as of April 30, 2021 –
– Second dose cohort to be initiated after the third patient completes 28 day follow up, absent any DLT –
– Acute safety data from the second and third cohorts are anticipated in the third and fourth quarters of 2021, respectively. Topline data on target engagement in the first cohort are expected in the second half of 2021 –
– Company to host conference call today at 8:30 a.m. ET –
PHILADELPHIA, May 03, 2021 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced acute safety data from the first dose cohort of the ongoing DesCAARTes™ Phase 1 clinical trial of DSG3-CAART for the treatment of patients with mucosal-dominant pemphigus vulgaris (mPV).
“We are encouraged by the acute safety profile of DSG3-CAART in this initial low dose cohort. 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, which we expect is the period with highest probability of observing treatment-related toxicities. In addition, 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,” said David J. Chang, M.D., Chief Medical Officer of Cabaletta. 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; DSG3-CAART was detected at low levels via quantitative polymerase chain reaction in both patients who have been evaluated and completed the 28-day DLT period. The third patient is scheduled to be evaluated for presence of DSG3-CAART after the 28-day follow-up period.
“The pace of the clinical trial is accelerating with the ongoing enrollment of patients and engagement of additional clinical sites. We believe these initial safety data represent an important step towards achieving our goal to offer a therapy that may provide deep and durable responses, and potentially cures, for patients in the pemphigus community,” said Dr. Chang.
The DesCAARTes™ trial is currently enrolling patients in the second cohort at a treatment dose of 100 million DSG3-CAART cells. Infusions are planned to initiate following the third patient in the first dose cohort completing the 28-day monitoring period without any DLTs. Cabaletta expects to announce acute safety data for the second and third cohorts 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. Cabaletta will continue to provide additional topline safety and target engagement data from the DesCAARTes™ trial once available on a cohort-by-cohort basis.
Conference Call Details
About the DesCAARTes™ Clincal Trial
About Pemphigus Vulgaris
About CAAR T Cell Therapy
Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: Cabaletta’s ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its clinical trials of DSG3-CAART; risks related to clinical trial site activation or enrollment rates that are lower than expected; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to the impact of public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19; risks related to Cabaletta’s ability to protect and maintain its intellectual property position; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; and the risk that the initial or interim results of clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Cabaletta’s most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta’s other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.
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