Foralumab

Foralumab (NI-0401) is a potent, orally active humanized monoclonal antibody targeting the CD3. Foralumab modulates immune responses by human cells in NSG mice that were reconstituted with human hematopoietic stem cells[1].

Signaling Pathways >> Others >> Others

Research Areas >> Inflammation/Immunology

Target: CD3

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. 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

[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.