Besufetamig (ONO-4685) is a bispecific antibody that simultaneously targets PD-1 and CD3. Besufetamig achieves CTL-mediated tumor cell killing. Besufetamig inhibits tumor growth in PBMC mouse xenograft models of PD-1-expressing T-cell lymphoma/leukemia [1] [2] [3].
In Vivo, Besufetamig suppresses tumor growth in a dose-dependent manner in PBMC-humanized mouse xenograft models of PD-1-expressing T-cell lymphoma/leukemia[1].
In Vitro, Besufetamig induces potent cytolytic killing of PD-1-expressing ILT-Mat, HPB-ALL, and SUP-T1 cell lines and induces granzyme B expression in CD4+ and CD8+ T cells; it also mediates cytotoxicity against PD-1-expressing target cells with PBMCs from ATLL samples[1].
References:
[1]. Naho Tateshit, et al. Abstract 7324: ONO-4685: A novel PD-1/CD3 bispecifc T-cell engager (TCE) for the treatment of T-cell malignancies. Cancer Res (2025) 85 (8_Supplement_1): 7324.
[2]. Case KB, et al. Advances in Novel Systemic Therapies for the Management of Cutaneous T Cell Lymphoma (CTCL). Current hematologic malignancy reports. 2025 Jan 13;20(1):5.
[3]. Xue E, et al. Trial Watch - bispecific T cell engagers and higher-order multispecific immunotherapeutics. Oncoimmunology. 2026 Dec 31;15(1):2632421.
In Vivo, Besufetamig suppresses tumor growth in a dose-dependent manner in PBMC-humanized mouse xenograft models of PD-1-expressing T-cell lymphoma/leukemia[1].
In Vitro, Besufetamig induces potent cytolytic killing of PD-1-expressing ILT-Mat, HPB-ALL, and SUP-T1 cell lines and induces granzyme B expression in CD4+ and CD8+ T cells; it also mediates cytotoxicity against PD-1-expressing target cells with PBMCs from ATLL samples[1].
References:
[1]. Naho Tateshit, et al. Abstract 7324: ONO-4685: A novel PD-1/CD3 bispecifc T-cell engager (TCE) for the treatment of T-cell malignancies. Cancer Res (2025) 85 (8_Supplement_1): 7324.
[2]. Case KB, et al. Advances in Novel Systemic Therapies for the Management of Cutaneous T Cell Lymphoma (CTCL). Current hematologic malignancy reports. 2025 Jan 13;20(1):5.
[3]. Xue E, et al. Trial Watch - bispecific T cell engagers and higher-order multispecific immunotherapeutics. Oncoimmunology. 2026 Dec 31;15(1):2632421.