Clinical-stage biopharmaceutical company AbelZeta Pharma Inc announced on Monday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted PRIority MEdicines (PRIME) designation for C-CAR168, the company's novel autologous anti-CD20/BCMA CAR-T product candidate, for the treatment of refractory Systemic Lupus Erythematosus (SLE), with or without Lupus Nephritis (LN).

C-CAR168 is designed to support deep depletion of disease-driving B cells and plasma cells, with the goal of inducing an immune reset in patients with severe autoimmune diseases, including refractory SLE and LN, and progressive Multiple Sclerosis (MS).

AbelZeta said that the granting of EMA PRIME designation marks one of the first major regulatory recognitions of a CAR-T therapy for SLE, highlighting both the significant unmet need faced by lupus patients and the potential of this approach to transform treatment. Building on the clinical promise demonstrated by earlier CAR-T therapies, AbelZeta has applied expertise in developing dual-target CAR-T technology to engineer its dual anti-CD20/BCMA-targeted CAR-T. This next-generation construct has been rationally designed to more effectively address the underlying immunopathology of lupus by targeting both autoreactive B cells and antibody-producing plasma cells, aiming to achieve deeper, more durable remissions while maintaining a favourable safety profile.