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Cudarolimab (IBI101) is a completely human anti-OX40 (CD134, a co stimulating molecule expressed by activated immune cells) antibody. Cudarolimab inhibits the binding of OX40 to its ligand OX40L. Cudarolimab has antitumor activity and can be used in cancer related research[1]. | [in vivo]
Cudarolimab (10 mg/kg; i.p.; single dose on days 3, 7, 11, 14 and 15) significantly reduces tumor volume in humanized NOG mice bearing LoVo tumors[1].
Cudarolimab (0.1, 1 and 10 mg/kg; i.p.; single dose on days 6, 9, 12 and 16) significantly reduces tumor volume, increases IFN-γ+ and IFN-α+ expression in CD8+ T cells in tumor and spleen of human OX40 knock-in mice bearing MC38 tumors[1].
Cudarolimab (10 mg/kg; i.p.; single dose on days 10 and 14) significantly reduces the expression of CD3+CD8+, CD3+CD4+, CD4+CD25highFoxP3+ in the tumor and spleen of human OX40 knock-in mice bearing MC38 tumors[1].
Pharmacokinetic (PK) parameters of Cudarolimab in cynomolgus macaques[1]
| Dose (mg/kg) | Cmax (μg/mL ) | Tmax (h) | AUC0-∞ (h?μg/mL ) | T1/2 (h) | Cl (mL/h/kg) | MRTlast (h) | | 0.1 | 3.07±0.40 | 0.08±0.00 | 347.98±99.30 | 162.98±103.01 | 0.31±0.08 | 186.34±110.68 | | 0.5 | 9.78±3.27 | 0.40±0.78 | 1429.19±607.21 | 129.47±114.44 | 0.40±0.14 | 136.03±108.05 | | 2.5 | 63.10±15.29 | 0.08±0.00 | 10304.06±3403.59 | 190.89±92.94 | 0.27±0.09 | 212.29±114.61 | | 12.5 | 296.57±58.05 | 0.40±0.78 | 33511.65±14982.36 | 120.30±153.26 | 0.44±0.20 | 114.93±87.66 |
| Animal Model: | Humanized NOG mice bearing LoVo tumors[1]. | | Dosage: | 10 mg/kg. | | Administration: | Intraperitoneal injection; single dose on days 3, 7, 11, 14 and 15. | | Result: | Reduced tumor volume. |
| Animal Model: | Human OX40 knock-in mice bearing MC38 tumors[1]. | | Dosage: | 0.1, 1 and 10 mg/kg. | | Administration: | Intraperitoneal injection; single dose on days 6, 9, 10, 12, 14 and 16. | | Result: | Showed anti-tumor activity. |
| [References]
[1] Kuang Z, et al. Development and characterization of a novel anti-OX40 antibody for potent immune activation. Cancer Immunol Immunother. 2020 Jun;69(6):939-950. DOI:10.1007/s00262-020-02501-2 |
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