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Foralumab (NI-0401) is a potent, orally active human monoclonal antibody targeting the CD3. Foralumab modulates immune responses by human cells in NSG mice that were reconstituted with human hematopoietic stem cells[1]. | [in vivo]
Foralumab (NI-0401; 0.6-250 μg; p.o.; daily, for 5 d) delays the rejection of B6Rag2?/? skin grafted onto the humanized mice[1].
Foralumab (0.6-250 μg; p.o. and i.h.; daily, for 5 d) prevents skin xenograft rejection in mice with human immune systems[1].
Foralumab (1-15 μg; p.o.; daily, for 5 d) has good bioavailability of intragastric in humanized mice[1].
| Animal Model: | Humanized NOD/SCID IL-2γc?/? mice with Skin grafts (Humanized mice: CD34+ cells are injected intra-hepatically into irradiated (0.9 Gy) NSG pups within 48 hours of birth) [1] | | Dosage: | 15 μg | | Administration: | Oral administration; daily, for 5 days and weekly dosing | | Result: | Showed robust protection against graft rejection and prolongs graft survival.
Reduced proliferation of CD8+ T cells and reduced release of TNF.
Increased the concentration of IL-10.
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| Animal Model: | Humanized NOD/SCID IL-2γc?/? mice with Skin grafts (Humanized mice: CD34+ cells are injected intra-hepatically into irradiated (0.9 Gy) NSG pups within 48 hours of birth) [1] | | Dosage: | 1, 5, 15, 50, and 250 μg (p.o.), 0.6 mg/kg (i.h.) | | Administration: | Oral administration and subcutaneous injection; daily, for 5 days and weekly dosing | | Result: | Had tolerant to autologous skin grafts in humanized mice. |
| Animal Model: | Humanized NOD/SCID IL-2γc?/? mice with Skin grafts (Humanized mice: CD34+ cells are injected intra-hepatically into irradiated (0.9 Gy) NSG pups within 48 hours of birth) [1] | | Dosage: | 0, 5, 10, and 15 μg | | Administration: | Oral administration and subcutaneous injection; daily, for 5 days and weekly dosing | | Result: | Increased human Ig on the surface of CD4+ and CD8+ T cells.
Had free mAb in the serum of mice
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| [References]
[1] Ogura M, et, al. Oral treatment with foralumab, a fully human anti-CD3 monoclonal antibody, prevents skin xenograft rejection in humanized mice. Clin Immunol. 2017 Oct;183:240-246. DOI:10.1016/j.clim.2017.07.005 |
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