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Porustobart + toripalimab is a **combination therapy** consisting of porustobart (HBM4003), a next-generation, fully human heavy-chain only monoclonal antibody targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), and toripalimab, a recombinant, humanized monoclonal antibody targeting programmed death-1 (PD-1) checkpoint. Porustobart is engineered to enhance antibody-dependent cellular cytotoxicity (ADCC), efficiently depleting high CTLA-4-expressing regulatory T cells (Tregs) within the tumor microenvironment, thereby boosting anti-tumor immunity. Toripalimab blocks the PD-1 receptor on T cells, preventing tumor cells from evading immune surveillance. The combination has demonstrated promising anti-tumor activity and a manageable safety profile in phase I/Ib studies for advanced solid tumors, especially in advanced melanoma and hepatocellular carcinoma, with higher efficacy observed in patients who were anti-PD-1/PD-L1 naïve. Porustobart was developed using the Harbour Mice® HCAb platform by Harbour BioMed. Primary indications under clinical investigation include advanced melanoma (notably mucosal subtype) and hepatocellular carcinoma.
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