Cabaletta Bio: rese-cel shows deepening responses; 3/4 SLE in remission, first LN complete renal response

Cabaletta Bio, Inc.

3 of 4 non-renal SLE patients achieved DORIS remission; first LN patient achieved complete renal response; all 6 SLE/LN patients off immunosuppressants and steroids.
First dermatomyositis patient maintained major TIS improvement at 3 months off all therapies; IMNM patients showed more gradual improvement.
First SSc patient showed skin improvements and lung function improvement at 3 months post-infusion off disease-specific therapies.
Safety: 90% of first 10 patients had no or Grade 1 CRS; 90% had no ICANS. Deep B cell depletion confirmed via lymph node biopsy.
Enrollment: 50 clinical sites actively recruiting; 26 patients enrolled as of Feb 13, 2025; plan to meet FDA in H1 2025 on registrational design.

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