ABA-101

ABA-101 is an autologous regulatory T cell (Treg) therapy in development for the treatment of progressive multiple sclerosis, including primary progressive and nonactive secondary progressive forms. Developed by Abata Therapeutics, ABA-101 is created by engineering a patient’s own Tregs to express a T cell receptor (TCR) that specifically recognizes immunogenic myelin fragments in the central nervous system (CNS). This targeted approach aims to provide a highly localized anti-inflammatory effect at sites of disease activity. The therapy is designed for patients with imaging evidence of ongoing inflammatory tissue injury who are HLA-DRB1*15:01 positive—a subgroup estimated at about 45,000 individuals in the U.S. Preclinical studies have shown that ABA-101 retains its Treg phenotype under inflammatory conditions and demonstrates antigen-specific functionality, anti-inflammatory cytokine production, suppression of pro-inflammatory cytokines, and therapeutic effects. The FDA has granted Fast Track designation for this therapy, and it is currently entering Phase 1 clinical trials.