Pharma Focus Asia

Cabaletta Bio Receives FDA Clearance of IND Application for CABA-201

Tuesday, May 16, 2023

Cabaletta Bio announced the second Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, has been cleared by the U.S. Food and Drug Administration (FDA) for a Phase 1/2 study in patients with active idiopathic inflammatory myopathy (IIM, or myositis).

The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 for the treatment of six patients with dermatomyositis (DM), six patients with anti-synthetase syndrome (ASyS), and six patients with immune-mediated necrotising myopathy (IMNM), all in separate parallel cohorts.

Similar to the Phase 1/2 trial design in SLE, this clinical trial will include patients with several different subtypes of myositis where B cells may be involved in disease pathology. 

With an experienced team well-versed in conducting autoimmune-focused cell therapy trials, and a product candidate specifically engineered for patients with autoimmune diseases, the potential for CABA-201 is evaluated to change the treatment paradigm for patients with autoimmune diseases.

Myositis refers to a group of autoimmune diseases characterised by inflammation and muscle weakness. In some cases, myositis may also affect other organs and systems in the body, such as the lungs, heart, or skin.

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