漢康生技最新多靶點免疫療法藥物HCB303啟動進入新藥臨床試驗申請準備階段
【TAIPEI, SHANGHAI, and SAN FRANCISCO, Jul 11, 2025】
HCB303 is a novel fusion protein designed to simultaneously target multiple major immunosuppressive pathways, including PD-L1/PD-1, SIRPα/CD47, and others. By engaging both the innate and adaptive immune systems, HCB303 aims to comprehensively enhance immune activation within the tumor microenvironment. The molecule is engineered for precise targeting of tumor cells expressing, PD-L1, and CD47, leading to T cell activation, natural killer (NK) cell cytotoxicity, and macrophage-mediated phagocytosis.
In in vitro studies, HCB303 exhibited superior binding and blocking capabilities at its intended targets. It outperformed existing antibody therapies across multiple functional assays, including maintaining CD226 (an activating receptor) expression, promoting T cell activation, and enhancing phagocytosis against PD-L1-high tumor cells.
In in vivo animal models, HCB303 demonstrated robust tumor inhibition in both human PBMC/tumor co-mixed xenograft model and hTIGIT/hCD47 transgenic mouse model. Treatment with HCB303 led to increased activation of immune cells and a higher proportion of tumor-infiltrating lymphocytes (TILs), supporting its efficacy through multiple immune-modulatory mechanisms.
Furthermore, preliminary toxicology and pharmacokinetic (PK) studies in cynomolgus monkeys indicate that HCB303 demonstrates good tolerability and predictable PK characteristics, establishing a solid foundation for IND filing and future clinical development.
HCB303 is currently in the process development phase, with an IND submission targeted for completion by 2026. The development of HCB303 represents a new milestone in HanchorBio’s multi-target immunotherapy approach. The company will continue to optimize drug design and expand clinical application potential, hoping to provide breakthrough treatment options for patients with refractory cancers.
HCB303是一款創新型融合蛋白，同時針對PD-L1/PD-1(針對T細胞)、SIRPα/CD47(針對巨噬細胞)與針對自然殺手細胞的抗癌分子等三大免疫抑制通路，旨在整合先天與後天免疫反應，並全面提升腫瘤微環境中的免疫活性。該分子設計可針對表現、PD-L1與CD47的腫瘤細胞精準地攻擊，並誘導T細胞活化、自然殺手細胞（NK）毒殺作用及巨噬細胞吞噬反應。
細胞實驗結果顯示，HCB303展現出優異的靶點結合與阻斷能力，並在多項功能性測試中超越現有抗體藥物，包括維持激活型受體CD226的表現、促進T細胞活化 ，以及強化對PD-L1高表現腫瘤細胞的吞噬活性。
在體內動物模型中，HCB303於人PBMC/腫瘤混合異種移植模型與hTIGIT/hCD47轉殖小鼠模型中均展現出顯著的腫瘤抑制效果，伴隨免疫細胞活化與腫瘤浸潤淋巴球（TILs）比例提升，更證實了多重免疫調節機制的有效性。
此外，初步毒理與藥代動力學（PK）研究顯示，HCB303在恆河猴中具備良好耐受性與可預測的藥物動力學特性，為後續新藥臨床試驗 (IND) 申請與臨床試驗奠定基礎。
HCB303目前已進入製程開發階段，預計在2026年底前完成新藥臨床試驗申請。HCB303的開發代表著漢康生技多靶點免疫療法的新里程碑，公司未來將持續優化藥物設計並拓展臨床應用潛力，期望為難治性癌症患者帶來突破性治療選擇。