Cabaletta Bio outlines 2026 strategic priorities for autoimmune therapy

Cabaletta Bio Inc. (NASDAQ: CABA) announced its 2026 strategic priorities for developing rese-cel, an investigational cell therapy for autoimmune diseases. The company is actively enrolling patients in a registrational myositis trial with a planned 17-patient cohort and expects to submit a Biologics License Application in 2027.

The company initiated a U.S. Food and Drug Administration-aligned dermatomyositis and antisynthetase syndrome registrational cohort in December 2025. These subtypes affect approximately 70,000 patients in the U.S., with dermatomyositis comprising about 60,000 patients. The registrational cohort will evaluate 17 patients with a 16-week primary endpoint measuring response while off immunomodulators and on no or low-dose steroids.

Cabaletta received FDA clearance for an investigational new drug amendment to manufacture rese-cel using Cellares' automated platform. The company expects clinical manufacturing data in the first half of 2026 to confirm good manufacturing practice readiness. This represents the first time an autologous CAR T program has received such clearance for the Cellares Cell Shuttle platform.

The FDA granted Cabaletta a Regenerative Medicine Advanced Therapy designation for rese-cel in treating systemic sclerosis. The company has also aligned with the FDA on registrational cohort designs for systemic lupus erythematosus and lupus nephritis, each evaluating approximately 25 patients in single-arm cohorts.

Cabaletta is evaluating rese-cel without preconditioning in patients with pemphigus vulgaris at higher doses, with additional durability data expected in the first half of 2026. The company added a dose-escalation cohort without preconditioning in its lupus trial based on safety and activity data from initial doses.

"The safety profile of a single, weight-based dose of rese-cel gives us confidence in the potential for outpatient treatment," said Steven Nichtberger, Chief Executive Officer of Cabaletta.

Complete Phase 1/2 data from lupus, scleroderma and myasthenia gravis trials are anticipated in the first half of 2026, according to the company's press release statement.

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