Drug intelligence / Profile preview

interleukin-15 fusion protein BJ-001

Development stage
Phase 1
Lead developer
BJ Bioscience
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Small Molecules, Interleukins → Cytokines & Interferons → Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
Administration
Intravenous, Subcutaneous
01

Overview

BJ-001 is a first-in-class, tumor-targeting recombinant human interleukin-15 (IL-15) fusion protein. It is composed of an integrin-binding Arg-Gly-Asp (RGD)-4C motif linked to a human IgG1 Fc region, followed by a modified sushi domain of the human IL-15 receptor alpha (IL-15Rα) and human IL-15. The drug is designed to target tumors with integrin overexpression and stimulate immune responses via the IL-15 pathway. Its mechanism involves acting as an agonist at the interleukin 15 receptor subunit alpha, promoting natural killer (NK) cell proliferation while maintaining regulatory T cell stability. Developed by BJ Bioscience, it is being investigated primarily for cancer indications such as solid tumors and infectious diseases. As of early 2025, it has orphan drug designation for cholangiocarcinoma and has reached Phase 1 clinical trials in both oncology and infectious disease settings[1][3][4][5][8].

Other names
interleukin-15 fusion protein BJ-001interleukin15 fusion protein BJ-001interleukin 15 fusion protein BJ-001
02

Targets

αVβ3 (Integrin αVβ3)IL2RB (IL-2 receptor beta chain)

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