Drug intelligence / Profile preview

HX009

Development stage
Phase 2
Lead developer
Waterstone Hanxbio
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

HX009 is a first-in-class, rationally designed bispecific antibody that targets both programmed cell death protein 1 (PD-1) and CD47. It features weakened CD47 binding to selectively enhance its activity within the tumor microenvironment via PD-1 interaction, aiming to exert potent anti-tumor effects with potentially lower toxicity compared to other agents targeting these pathways. Mechanistically, HX009 blocks PD-1 on T lymphocytes and CD47 on tumor cells; this dual blockade stimulates T cell activation and relieves the "don't eat me" signal mediated by CD47/SIRPα interaction, thereby promoting macrophage-mediated phagocytosis of tumor cells. Preclinical studies have demonstrated strong anti-tumor activity in lymphoma models and solid tumors. Clinical trials are ongoing in patients with advanced solid tumors, lymphoma, and malignant melanoma[1][2][4][5][6].

02

Targets

CD47 (Cluster of Differentiation 47)PDCD1 (Programmed cell death protein 1 receptor)

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