A BCMAxCD3 bispecific T-cell engager is entering human testing for the first time in a broad autoimmune indication, marking a notable extension of a modality that has demonstrated clinical proof-of-concept in multiple myeloma into diseases such as systemic lupus erythematosus and systemic sclerosis. Otsuka Pharmaceutical Development & Commercialization, Inc., the US development subsidiary of Tokyo Stock Exchange-listed Otsuka Holdings Co., Ltd. (TSE: 4578), has registered a first-in-human Phase I trial of HBM7020 (NCT07649265), an intravenous bispecific antibody licensed from Hong Kong-listed Harbour BioMed. The trial's focus on B-cell-driven autoimmune conditions reflects growing clinical interest in plasma cell depletion as a disease-modifying strategy beyond oncology.
The Phase I study is structured as an open-label, multicenter, sequential dose-escalation trial enrolling approximately 63 participants, according to the trial record. It is scheduled to begin in Q3 2026, with primary completion anticipated in Q4 2028. The design moves from healthy volunteers at lower doses into patients with moderate to severe active disease across four indications: systemic lupus erythematosus (SLE), systemic sclerosis (SSc), Sjögren's disease (SjD), and rheumatoid arthritis (RA). A Part 2 component allows optional retreatment for eligible participants who completed Part 1. Patient eligibility requires confirmed autoimmune disease supported by autoantibody findings, active disease meeting protocol-defined severity thresholds, and stable background therapy prior to dosing. The primary endpoints assess safety and pharmacodynamic activity, while secondary endpoints focus on pharmacokinetics assessment.
HBM7020 was originated by Harbour BioMed using its proprietary HBICE (HCAb-Based Immune Cell Engager) bispecific technology and Harbour Mice transgenic platform, which generate fully human antibodies in a heavy-chain-only format. The molecule simultaneously engages BCMA (B-Cell Maturation Antigen, TNFRSF17) on plasma cells and plasmablasts, and CD3 on T cells, redirecting cytotoxic T-cell activity toward BCMA-expressing cells. In the autoimmune context, the intended consequence is depletion of the long-lived plasma cells and plasmablasts responsible for sustained pathogenic autoantibody production — a mechanism that distinguishes this approach from conventional B-cell-depleting agents such as anti-CD20 therapies, which spare differentiated plasma cells. Otsuka obtained an exclusive global license to HBM7020 outside Greater China through a strategic collaboration with Harbour BioMed announced in June 2025. Harbour BioMed retains rights in Greater China.
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