Welcome to our dedicated page for Cabaletta Bio news (Ticker: CABA), a resource for investors and traders seeking the latest updates and insights on Cabaletta Bio stock.
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, 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.
Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company, announced its participation in two investor conferences in September 2021. The Morgan Stanley 19th Annual Global Healthcare Conference will feature a fireside chat with CEO Steven Nichtberger on September 9, while the H.C. Wainwright 23rd Annual Global Investment Conference will include a pre-recorded chat available on September 13. Both presentations will be accessible on Cabaletta's website for 90 days. The company focuses on engineered T cell therapies for B cell-mediated autoimmune diseases, with its lead candidate DSG3-CAART in Phase 1 trials.
Cabaletta Bio reported promising results from its DesCAARTes™ Phase 1 clinical trial regarding DSG3-CAART for treating mucosal pemphigus vulgaris. As of August 17, no dose-limiting toxicities or significant adverse events occurred in the second cohort, which received 100 million cells. DSG3-CAART persistence was confirmed in all three patients during the 28 days post-infusion. The trial has now moved to a third cohort, dosing 500 million cells, with safety and efficacy data expected in Q4 2021. The company aims to develop targeted therapies for autoimmune diseases while avoiding generalized immunosuppression.
Cabaletta Bio, Inc. (Nasdaq: CABA) reported Q2 2021 financial results and updates on its clinical trials. The company is progressing with the DesCAARTes™ trial for DSG3-CAART, expecting to release safety data for additional patient cohorts in Q3 and Q4 2021. They plan to submit an IND for MuSK-CAART in H2 2021 and have requested a pre-IND meeting for PLA2R-CAART. Cash and equivalents stood at $102.8 million as of June 30, 2021. R&D expenses increased to $7.9 million from $5.3 million year-over-year.
Cabaletta Bio, Inc. (CABA) recently appointed Dr. Scott Brun to its Board of Directors. Dr. Brun, with over 20 years in drug development, previously held leadership roles at AbbVie and Abbott Laboratories. His expertise in autoimmune diseases aligns with Cabaletta's goal to advance its lead program, DSG3-CAART, targeting mucosal pemphigus vulgaris. Dr. Brun will also serve on the Audit and Nominating Committees. His appointment follows the resignation of Dr. Brian Daniels, who contributed to the board since 2018. The company aims to enhance shareholder value with this strategic addition.
On May 27, 2021, Cabaletta Bio, a clinical-stage biotechnology company focused on engineered T cell therapies, announced that CEO Steven Nichtberger will participate in a fireside chat at the Jefferies Healthcare Conference on June 3, 2021, at 4:30 p.m. ET. A live webcast will be available on the company’s website, with a replay accessible for 90 days post-event. Cabaletta's lead candidate, DSG3-CAART, is in a Phase 1 trial for treating mucosal pemphigus vulgaris, with Fast Track Designation from the FDA since May 2020.
Cabaletta Bio, Inc. reported promising initial safety data from the DesCAARTes™ trial for DSG3-CAART, showing no dose-limiting toxicities (DLTs) or adverse events in the first cohort. The company plans to advance two new programs: PLA2R-CAART for PLA2R-associated membranous nephropathy and MuSK-CAART for myasthenia gravis, with IND submissions anticipated in the latter half of 2021. Financially, Cabaletta reported a cash position of $102 million as of March 31, 2021, enabling operations through Q4 2022, despite rising R&D expenses of $6.6 million, up from $4.6 million in Q1 2020.
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