pp-183 Solution for infusion
Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Severe hyperferritinemic hemophagocytic lymphohistiocytosis (sHLH) / secondary HLH in adults and adolescents
Clinical stage: Phase 2/3 — SURPASS pivotal trial ongoing
Modality: Biological (humanised anti-SIRPα monoclonal antibody)
Mechanism / Target: First-in-class anti-signal regulatory protein α (SIRPα) antibody; blocks CD47–SIRPα innate immune checkpoint; prevents excessive macrophage activation driving cytokine storm in sHLH
Route / form: IV infusion
Differentiation: First-in-class anti-SIRPα mAb for a life-threatening hyperinflammatory syndrome with no approved disease-modifying therapy
Manufacturer #39324
Clinical-stage US biotech developing first-in-class Rx therapeutics targeting signal regulatory proteins (SIRPs) for immunological diseases and cancer. Injectable biologic pipeline advances through Phase 1/2 clinical trials with over $183 million in institutional financing. Operates from a major biotech hub with a global clinical development strategy.
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