Drug intelligence / Profile preview

A-319

Development stage
Phase 1
Lead developer
ITabMed
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

A-319 is a bispecific antibody designed to engage T cells for the targeted elimination of CD19-positive B cells. It binds both CD3 on T lymphocytes and CD19 on B cells, thereby activating T cells to kill malignant or autoreactive B cells. A-319 is being developed primarily for the treatment of B cell malignancies such as pre-B cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and non-Hodgkin's lymphoma (NHL). Additionally, it is under investigation for autoimmune diseases including severe/refractory systemic lupus erythematosus (SLE). The drug is produced in CHO cells using serum-free medium and formulated as a stable liquid product. Clinical studies have shown that A-319 can rapidly deplete pathogenic B cells with early evidence of efficacy in SLE patients, while demonstrating an acceptable safety profile without major adverse events commonly associated with other T cell-engaging therapies[1][3][8].

Other names
Recombinant Anti-CD19m-CD3 Antibody Injection
02

Targets

CD3 (T-cell surface glycoprotein CD3)CD19 (B lymphocyte antigen CD19)

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