Jul 11, 2025

HanchorBio Prepares HCB303 Multi-Target Immunotherapy for IND Filing

【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.
Jun 03, 2025
HanchorBio Presents Promising Phase 1 HCB101 Data at ASCO 2025 – Confirmed Partial Response Observed in Solid Tumor and Lymphoma Patients
HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, today presented interim data from its lead immunotherapy product, HCB101, following its poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31 – June 4 in Chicago, Illinois. The data, featured in a poster session, demonstrated favorable safety, high CD47 receptor occupancy, and early clinical signs of anti-tumor activity, including confirmed partial response (PR) in patients with head and neck cancer (HNSCC) and marginal zone lymphoma.
Jul 17, 2025
HanchorBio Receives Third Taiwan TFDA Approval for HCB101 Combination Therapy in Advanced Gastric Cancer
HanchorBio Inc. (7827.TWO), a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, today announced that the Taiwan Food and Drug Administration (TFDA) has approved a third investigator-initiated trial (IIT) evaluating HCB101 in combination with zolbetuximab and chemotherapy for the first-line treatment of patients with HER2-negative, CLDN18.2-positive advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.