Cabaletta Bio Announces Updated Clinical Data and Corporate Presentation

Cabaletta Bio, Inc. (NASDAQ: CABA) shared significant updates on February 18, 2025. The company’s recent disclosures included an updated corporate presentation posted on its official website and a press release unveiling novel clinical data from the initial 10 patients treated with resecabtagene autoleucel (rese-cel), previously known as CABA-201, across its RESET clinical development program.

The Corporate Presentation, accessible on the “Investors & Media” section of Cabaletta’s website, offers a corporate overview and outlines an updated development plan. Simultaneously, the Press Release introduced the new and updated clinical data from patients in the RESET program.

Cabaletta Bio is actively engaged in evaluating rese-cel across the RESET (REstoring SElf-Tolerance) initiative, overseeing six Phase 1/2 clinical trials with disease-specific groups across varied therapeutic realms like rheumatology, neurology, and dermatology. The trials involve a weight-based single infusion of rese-cel post a pre-treatment regimen of fludarabine and cyclophosphamide, except for the RESET-PV™ trial, which adopts weight-based dosing of rese-cel sans preconditioning.

The clinical data compiled up to January 8, 2025, revealed substantial findings notably across the RESET-Myositis™, RESET-SLE™, and RESET-SSc™ trials:

– In the RESET-Myositis trial, progress was observed in patients with dermatomyositis and immune-mediated necrotizing myopathy, hinting at diverse response rates among myositis subtypes.
– Within the RESET-SLE trial, patients showcased significant remissions, including a complete renal response in lupus nephritis patients.
– The RESET-SSc trial illustrated encouraging skin and lung function improvements in participants. Rese-cel demonstrated notable B cell depletion and a favorable safety profile in the initial patient cohort.

The disclosed information is for regulation FD disclosure and other events, striving to present deep clinical responses across various indications with rese-cel.

These forward-looking statements provide insights into Cabaletta’s vision and present challenges. The company, in its relentless pursuit, is committed to releasing detailed data, aligning with regulatory bodies, and advancing therapeutic potential for autoimmune patients.

Contact:
Anup Marda
Chief Financial Officer
[email protected]

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Cabaletta Bio’s 8K filing here.

Cabaletta Bio Company Profile

Cabaletta Bio, Inc, a clinical-stage biotechnology company, focuses on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases. The company's lead product candidate is CABA-201, a fully human anti-CD19 binder for the treatment of Phase 1/2 clinical trials in dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy, lupus nephritis, non-renal systemic lupus erythematosus, systemic sclerosis, and generalized myasthenia gravis.