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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].
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