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HCB-101 is an engineered human Signal Regulatory Protein Alpha (SIRPα) fused to a human IgG4 crystallizable fragment (Fc) protein, developed using HanchorBio's proprietary FBDB™ platform. This recombinant fusion protein functions as an innate immunity checkpoint inhibitor by blocking the "do not eat" signal of the CD47-SIRPα pathway. By binding to CD47 on tumor cells, HCB-101 prevents its interaction with SIRPα on macrophages, thereby enhancing macrophage-mediated phagocytosis of cancer cells. Preclinical studies have demonstrated its potent antitumor activity across various solid tumors and hematological malignancies, with a favorable safety profile designed to mitigate the on-target toxicities, such as severe anemia, observed with earlier CD47-targeting agents. HCB-101 also promotes the repolarization of tumor-associated macrophages towards a pro-inflammatory M1 phenotype within the tumor microenvironment, contributing to its anti-tumor effects. It is currently undergoing clinical development for advanced solid tumors and non-Hodgkin lymphoma.
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