{"id":485593,"date":"2021-05-03T07:08:38","date_gmt":"2021-05-03T11:08:38","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/cabaletta-bio-reports-first-quarter-2021-financial-results-and-provides-new-pipeline-updates\/"},"modified":"2021-05-03T07:08:38","modified_gmt":"2021-05-03T11:08:38","slug":"cabaletta-bio-reports-first-quarter-2021-financial-results-and-provides-new-pipeline-updates","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/cabaletta-bio-reports-first-quarter-2021-financial-results-and-provides-new-pipeline-updates\/","title":{"rendered":"Cabaletta Bio Reports First Quarter 2021 Financial Results and Provides New Pipeline Updates"},"content":{"rendered":"
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\n \u2013 Acute safety data from the first cohort in the DesCAARTes\u2122 trial announced today; no dose limiting toxicities (DLTs) or clinically relevant adverse events observed in the first dose cohort as of April 30, 2021 \u2013<\/em>
\n \n <\/p>\n

\n \u2013 PLA2R-CAART announced as a new development program for patients with PLA2R-associated membranous nephropathy; pre-IND meeting with FDA planned in the second half of 2021 \u2013<\/em>\n <\/p>\n

\n \u2013 MuSK-CAART Investigational New Drug (IND) application submission planned for the second half of 2021 \u2013<\/em>\n <\/p>\n

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 reported financial results for the first quarter ended March 31, 2021, and provided new pipeline updates.<\/p>\n

\u201cThe initial safety data from the first low dose cohort of three patients in the DesCAARTes\u2122 clinical trial for DSG3-CAART, our lead clinical candidate, support the acute safety profile of DSG3-CAART at the administered dose in mucosal-dominant pemphigus vulgaris patients, and are an encouraging indicator for the safety of the CAAR T platform overall. We look forward to reporting additional topline data on safety and potential target engagement on completed dose cohorts throughout the second half of 2021,\u201d said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta. \u201cOn the heels of this important milestone, which we believe begins to de-risk our CABA\u2122 platform, we are pleased to announce a new development program, PLA2R-CAART, for the treatment of patients with PLA2R-associated membranous nephropathy with a pre-IND meeting planned for the second half of 2021. In addition, we look forward to submitting our second IND application for MuSK-CAART, our lead preclinical candidate, in the second half of 2021.”<\/p>\n

\n Acute Safety Data from First Dose Cohort of DesCAARTes\u2122 Trial<\/strong>\n <\/p>\n

Today, the Company reported results from 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 the Company expects is the period with highest probability of observing treatment-related toxicities. In addition, no dose-limiting toxicities (DLTs) were observed in the first two subjects who have completed the 28-day DLT monitoring period post-infusion. The third patient has completed the 8-day acute safety window, and is in the DLT follow-up period. 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 completed the 28-day DLT period and been evaluated. The third patient is scheduled to be evaluated for presence of DSG3-CAART after completion of the 28-day DLT monitoring period.<\/p>\n

The DesCAARTes\u2122 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 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\u2122 trial once available on a cohort-by-cohort basis.<\/p>\n

\n Other Pipeline Highlights <\/strong>\n <\/p>\n

\n MuSK-CAART: <\/strong>Muscle Specific Kinase (MuSK) chimeric autoantibody receptor T (MuSK-CAART) cells as potential treatment for patients with MuSK-associated myasthenia gravis.<\/p>\n