AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, announced 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).

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 extensive 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, with the goal of achieving deeper, more durable remissions while maintaining a favorable safety profile.

"The PRIME designation represents another significant milestone for AbelZeta's scientific capabilities and further demonstrates that well-designed early clinical trials can generate highly clinically meaningful results that translate into regulatory recognition and inform global drug development. This recognition reflects the strength of our scientific platform, the dedication of our team, and the significant progress we have made in expanding cell therapy well beyond oncology," said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. "It provides important momentum as we advance C-CAR168 through global development in multiple disease indications and further establishes AbelZeta as a leader in cell therapy for autoimmune diseases."

In May 2025, the U.S. Food and Drug Administration (FDA) also granted Regenerative Medicine Advanced Therapy (RMAT) designation to C-CAR168 for the treatment of refractory SLE, including LN.