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Cabaletta Bio, Inc. (symbol: CABA) is a clinical-stage biotechnology company dedicated to the discovery and development of engineered T cell therapies for patients suffering from B cell-mediated autoimmune diseases. Utilizing its proprietary Chimeric AutoAntibody Receptor (CAAR) and Chimeric Antigen Receptor T cells for autoimmunity (CARTA) technologies, Cabaletta aims to provide targeted, effective, and potentially curative treatments.
The company's flagship product candidate, DSG3-CAART, is in Phase I clinical trials for treating mucosal pemphigus vulgaris, an autoimmune blistering skin disease. Other promising candidates include MuSK-CAART for myasthenia gravis and FVIII-CAART for a subset of patients with hemophilia A. Cabaletta is also actively developing DSG3/1-CAART for mucocutaneous pemphigus vulgaris, with several products in various stages of preclinical and discovery phases.
In recent developments, Cabaletta Bio received approval from the U.S. FDA for its Investigational New Drug (IND) application for CABA-201, a fully human CD19-CAR T cell investigational therapy for generalized myasthenia gravis (gMG). This expands their portfolio into neurology, complementing prior clearances for lupus, myositis, and systemic sclerosis. The upcoming Phase 1/2 clinical trial for CABA-201 aims to test its efficacy in treating gMG patients, potentially offering a groundbreaking one-time dose treatment.
Furthermore, Cabaletta has secured multiple Fast Track Designations from the FDA for CABA-201 in conditions like dermatomyositis and systemic sclerosis, facilitating expedited development and review. These designations highlight the critical unmet needs in these patient populations and amplify Cabaletta’s commitment to pioneering advanced therapies.
Based in Philadelphia, PA, Cabaletta Bio continues to advance its innovative pipeline, guided by robust scientific research and strategic collaborations. The company is well-positioned financially, with adequate resources to fund its operations into the first half of 2026. Cabaletta's mission is to harness the power of engineered T cells to unlock transformative therapies, offering patients durable, drug-free remissions and improved quality of life.
Cabaletta Bio, a clinical-stage biotechnology company (Nasdaq: CABA), announced that CEO Steven Nichtberger, M.D. will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 9:00 a.m. ET. A live webcast will be available on their website, with a replay accessible for 90 days.
The company focuses on engineered T cell therapies for B cell-mediated autoimmune diseases. Their lead candidate, DSG3-CAART, is in the DesCAARTes™ Phase 1 clinical trial for pemphigus vulgaris and has received Fast Track Designation from the FDA.
Cabaletta Bio, a clinical-stage biotechnology company focused on engineered T cell therapies, announced that CEO Steven Nichtberger will present a pre-recorded company presentation at the H.C. Wainwright BioConnect Conference. This presentation will be available for on-demand viewing starting January 10, 2022, at 7:00 a.m. ET. The replay will be accessible on the company's website for 90 days. The company is developing therapies targeting B cell-mediated autoimmune diseases, including its lead candidate DSG3-CAART for mucosal pemphigus vulgaris, which has received Fast Track Designation from the FDA.
Cabaletta Bio (Nasdaq: CABA) reported top-line results from the DesCAARTes™ Phase 1 trial evaluating DSG3-CAART for mucosal Pemphigus Vulgaris. As of December 12, 2021, six patients from the two lowest dose cohorts have completed follow-ups. Notable findings revealed that in cohort A1, two of three participants exhibited worsened disease activity, while one participant showed improvement. In cohort A2, two of three patients maintained stable conditions. The trial aims to expand dosage and optimize treatment efficacy, with future results expected in early 2022.
On November 9, 2021, Cabaletta Bio, a clinical-stage biotechnology company focused on engineered T cell therapies for B cell-mediated autoimmune diseases, announced its participation in two investor conferences. The events include the Guggenheim Securities 3rd Annual Neuro/Immunology Conference on November 16 and the Evercore ISI 4th Annual HealthCONx Conference on November 30, featuring fireside chats by CEO Steven Nichtberger. The company’s proprietary CABA™ platform targets specific autoantibody-producing B cells and is evaluating its lead candidate, DSG3-CAART, in a Phase 1 trial.
Cabaletta Bio, Inc. (Nasdaq: CABA) has appointed Samik Basu, M.D. as Chief Scientific Officer and Heather Harte-Hall as Chief Compliance Officer. Both executives have extensive experience and will report to Gwendolyn Binder, Ph.D., Executive Vice President of Science & Technology. Dr. Basu, previously Vice President of Preclinical Research, has a background in T-cell immunotherapy, while Ms. Harte-Hall has led compliance at Adaptimmune Therapeutics. These appointments aim to strengthen leadership as the company advances its DSG3-CAART product candidate for mucosal pemphigus vulgaris.
Cabaletta Bio reported promising updates from the DesCAARTes™ Phase 1 trial, highlighting a dose-dependent increase in DSG3-CAART persistence in the third patient cohort. No dose-limiting toxicities or significant adverse events were recorded as of October 31, 2021. The company ended Q3 2021 with $119.3M in cash and expects funding to last through 1Q23. Upcoming milestones include the top-line biologic activity data from the first two low-dose cohorts and an IND submission for MuSK-CAART.
Cabaletta Bio, Inc. (CABA) announced promising results from the DesCAARTes™ Phase 1 clinical trial for DSG3-CAART, targeting mucosal-dominant pemphigus vulgaris (mPV). Data as of October 31, 2021, indicates dose-dependent increases in cell persistence without adverse events across three cohorts. Dosing for the fourth cohort has commenced at 2.5 billion cells, with 28-day safety data expected in Q1 2022, while top-line biologic activity data from earlier cohorts is anticipated in Q4 2021. The trial has successfully increased participant sites to six, enhancing recruitment efforts.
Cabaletta Bio (CABA) announced promising preclinical data supporting its PLA2R-CAART therapy targeting B cells in PLA2R membranous nephropathy. The therapy demonstrated effective cytolysis of anti-PLA2R antibody-expressing B cells with no off-target interactions. An oral presentation will be given at ASN Kidney Week 2021, highlighting the potential for this precise treatment to spare healthy B cells. A pre-IND interaction with the FDA is scheduled for later this year, marking a key step in its development for high unmet medical needs.
Cabaletta Bio (Nasdaq: CABA) announced that its CEO, Steven Nichtberger, M.D., will participate in a fireside chat at the Chardan 5th Annual Genetic Medicines Conference on October 5, 2021, at 8:30 a.m. ET. A live webcast of the event will be available on the company's website, and a replay will be accessible for 90 days post-event. Cabaletta Bio focuses on engineered T cell therapies aimed at treating B cell-mediated autoimmune diseases, with its lead candidate, DSG3-CAART, currently in a phase 1 clinical trial for mucosal pemphigus vulgaris.
Cabaletta Bio (CABA) has appointed Michael Gerard as general counsel, a move intended to bolster its executive team as the company advances its clinical development of engineered T cell therapies for autoimmune diseases. Gerard brings extensive legal experience in life sciences, having previously served at Spark Therapeutics and Sandoz. His addition is expected to support the ongoing DesCAARTes™ trial for DSG3-CAART, which targets mucosal pemphigus vulgaris. The FDA granted Fast Track Designation for this candidate in May 2020, highlighting its potential therapeutic value.
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