Cabaletta Bio’s IND application for CABA-201 to treat systemic lupus erythematosus has been approved by the US FDA.

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The US Food and Drug Administration has approved the company’s investigational new drug (IND) application for CABA-201, a fully human CD19-CAR T cell investigational therapy that contains the 4-1BB protein, according to Cabaletta Bio, Inc., a clinical-stage biotechnology company focused on creating and marketing the first curative targeted cell therapies for patients with autoimmune diseases (FDA). For the treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis (LN) or active SLE without renal disease, the business intends to start a phase 1/2 clinical trial of CABA-201.

We think that the approval of this IND application within six months of the binding approval of CABA-201 is a significant step forward for autoimmune disease sufferers. The data package we submitted, which included clinical safety data with the CABA-201 binder, our expertise from earlier autoimmune cell therapy IND applications, and our exclusive translational research partnership with the senior author of the Nature Medicine paper—which demonstrated 5/5 durable remissions throughout the follow-up period up to 17 months in patients with refractory SLE—were all used to inform the efficient clinical trial design, according to Steven Nichtberger, M.D., chief executive officer of the SLE Foundation. Patients with active LN or SLE who don’t have renal involvement will start the phase 1/2 clinical trial.

We think CABA-201 has the potential to offer profound and long-lasting responses for individuals with SLE and maybe other autoimmune illnesses where B cells play a role in initiating or maintaining disease pathology based on its resemblance to the drug utilised in the Nature Medicine publication. We believe we are in a strong position to produce 3-month trial data on efficacy endpoints and tolerability for patients dosed with CABA-201 by the first half of 2024 by prompt IND clearance. The immune system destroys healthy tissue throughout the body in SLE, a chronic and potentially severe autoimmune illness that primarily affects young women between the ages of 15 and 40. It also affects persons of colour more frequently and severely. It is characterised by aberrant B cell function and autoantibody synthesis, which can cause end organ damage and an elevated risk of death, among other clinical signs. In the US, it is thought to impact between 160,000 and 320,000 persons altogether. LN, which affects about 40% of SLE patients, is the most frequent end-organ manifestation of the disease. Within 10 years after diagnosis, these patients had a roughly 17% risk of developing end-stage renal disease and a roughly 12% risk of passing away.

CABA-201 is intended to be administered as a single infusion and has the ability to completely but briefly eradicate B cells, enabling a “immune system reset” and long-lasting remission in SLE patients. The objective of the phase 1/2 clinical trial is to assess the efficacy and safety of CABA-201 in SLE patients with active LN or active SLE without renal involvement. Prior to receiving CABA-201 infusion, subjects will get a typical preconditioning treatment plan containing fludarabine and cyclophosphamide. The CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) approach, developed by Cabaletta, is being tested for the first time in this trial. Cabaletta Bio is a biotechnology business in the clinical stages that focuses on the discovery and development of modified T cell therapies that have the potential to offer patients with autoimmune illnesses a comprehensive and long-lasting, possibly curative, course of treatment.

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