AbGn-168H

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Ligands
AbGn-168H

GtoPdb Ligand ID: 10013

Synonyms: AbGn-168 | neihulizumab

Comment: AbGn-168H (neihulizumab) is a first-in-class, humanised anti-P-selectin glycoprotein 1 (PSGL-1) monoclonal antibody that is being developed by AbGenomics [2-3]. AbGn-168H targets the PSGL-1/P-selectin pathway that is involved in leukocyte recruitment to inflammatory sites. It blocks PSGL-1 expressed by activated T cells or NK cells, and inhibits their interaction with P-selectin on endothelial cells of the vasculature. AbGn-168H binds to a different epitope on P-selectin compared to the endogenous ligand PSGL-1 so it is not expected to interfere with the P-selectin-dependent recruitment of leukocytes that is essential for innate immunity. Nor does it alter aggregation of human platelets which express low levels of PSGL-1 [3].
Patent analysis identifies SEQ ID: 25 from AbGenomics' 2009 patent US7604800 [3] as the likely light chain variable region of AbGn-168H (DIQMTQSPSLSASVGDRVTITCRSSQSIVHNDGNTYFEWYQQKPGKAPKLLIYKVSNRFSGVPSRFSGSGSGTHFTLTISSLQPEDFATYYCFQGSYVPLTFGQGTKVEIK) and SEQ ID: 26 that is claimed in the same patent (EVQLVESGGGLVQPGGSLRLSCAASGFTFSTYAMSWVRQAPGKGLEWVASISTGGSTYYPDSVKGRFTISRDNAKNTLYLQMNSLRAEDTAVYYCARDYDGYFDYWGQGTLVTVSS) is the likely heavy chain. AbGn-168H was humanised from a murine anti-PSGL-1 antibody referred to as 15A7 [3].

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Summary of Clinical Use
AbGn-168H has completed Phase 2 clinical evaluation in patients with moderate to severe chronic plaque psoriasis (NCT01855880) and active psoriatic arthritis (NCT02267642). A Phase 2 study in patients with moderate to severe active, anti-TNFα and/or anti-integrin refractory ulcerative colitis has been initiated (NCT03298022), as has a Phase 1 study for steroid-refractory acute graft-versus-host disease (GvHD; NCT03327857). FDA orphan drug designation for the treatment of acute GvHD was granted in January 2018 [1].

Summary of Clinical Use

AbGn-168H has completed Phase 2 clinical evaluation in patients with moderate to severe chronic plaque psoriasis (NCT01855880) and active psoriatic arthritis (NCT02267642). A Phase 2 study in patients with moderate to severe active, anti-TNFα and/or anti-integrin refractory ulcerative colitis has been initiated (NCT03298022), as has a Phase 1 study for steroid-refractory acute graft-versus-host disease (GvHD; NCT03327857). FDA orphan drug designation for the treatment of acute GvHD was granted in January 2018 [1].

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT01855880	Phase IIa Study of Multiple Doses of AbGn-168H by iv Infusion in Moderate to Severe Chronic Plaque Psoriasis Patients	Phase 2 Interventional	AbGenomics B.V Taiwan Branch
NCT02267642	A Phase II Study Evaluating the Efficacy and Safety of AbGn-168H in Patients With Active Psoriatic Arthritis	Phase 2 Interventional	AbGenomics B.V Taiwan Branch
NCT03298022	Efficacy and Safety of AbGn-168H in Patients With Moderate to Severe Active, Anti-TNF Alpha and/or Anti-integrin Refractory Ulcerative Colitis	Phase 2 Interventional	AbGenomics International, Inc.
NCT03327857	Neihulizumab (AbGn-168H) in Patients With Steroid-refractory Acute Graft-versus-host Disease	Phase 1 Interventional	AbGenomics International, Inc.