CABA-201 is under clinical development by Cabaletta Bio and currently in Phase II for Immune Mediated Necrotizing Myopathy (IMNM). According to GlobalData, Phase II drugs for Immune Mediated Necrotizing Myopathy (IMNM) does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the CABA-201 LoA Report. Buy the report here.

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Data Insights Likelihood of Approval and Phase Transition Success Rate Model - CABA-201 in Immune Mediated Necrotizing Myopathy (IMNM)

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

CABA-201 overview

CABA-201 is under development for the treatment of B cell-mediated autoimmune diseases such as idiopathic inflammatory myopathy, systemic lupus erythematous, anti-synthetase syndrome, dermatomyositis, immune mediated necrotizing myopathy (IMNM), systemic sclerosis, generalized myasthenia gravis, juvenile dermatomyositis (juvenile myositis) and other multiple undisclosed indications. The therapeutic candidate is administered through intravenous route. It is an engineered lentiviral vector transduced CAR T cell comprising anti CD19 and 4-1BB as co-stimulator. It is being developed based on CABA platform.

Cabaletta Bio overview

Cabaletta Bio is a biopharmaceutical company that develops cellular therapies for the treatment of B cell-mediated autoimmune diseases. The company utilizes its platform that encompasses CARTA (chimeric antigen receptor T cells for autoimmunity) strategy and CAART (chimeric autoantibody receptor T cells) strategy. Its product pipeline includes CABA-201, a fully human CD19 chimeric antigen receptor to treat systemic lupus erythematosus, rheumatoid arthritis, myositis, and systemic sclerosis; and DSG3-CAART for the treatment of mucosal pemphigus vulgaris. Cabaletta is also investigating other programs including MuSK-CAART to treat myasthenia gravis; PLA2R-CAART against membranous nephropathy and DSG3/1-CAART for the treatment of mucocutaneous pemphigus vulgaris. Cabaletta Bio is headquartered in Philadelphia, Pennsylvania, US.

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This content was updated on 16 July 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.