HanchorBio, a global clinical-stage biopharmaceutical company, announced on August 13 that the first patient has been successfully dosed in an investigator-initiated trial (IIT) led by Dr. Chia-Hsun Hsieh of the Oncology Department at Linkou Chang Gung Memorial Hospital. The study is designed to evaluate HCB101 in combination with the immunotherapy pembrolizumab (Keytruda®) in patients with recurrent or metastatic head and neck cancer who are unresponsive to platinum-based chemotherapy, with the primary focus on safety and preliminary efficacy.
HCB101 is a novel immuno-oncology therapy that selectively targets CD47 on tumor cells, reducing off-target effects on healthy blood cells and lowering the risks of anemia and thrombocytopenia. By enhancing immune cell-mediated tumor phagocytosis, the drug activates both innate and adaptive immune responses. Key attributes include: (1) reduced risk of side effects through selective binding to tumor-associated CD47 with low affinity for red blood cells; (2) enhanced immune attack via increased antibody-dependent cellular phagocytosis (ADCP); (3) broad antitumor potential across more than 80 preclinical cancer models, including both solid and hematologic malignancies; and (4) promising early clinical activity, with cases of significant tumor shrinkage and disease stabilization for up to 40 weeks, suggesting durable anticancer effects.
The ongoing open-label, multi-center Phase I/II clinical trial in Taiwan aims to enroll approximately 50 participants. Primary objectives include evaluating safety, tolerability, and preliminary efficacy, while secondary endpoints cover progression-free survival (PFS), overall survival (OS), duration of tumor control, and biomarker analyses to identify patient populations most likely to benefit.
Dr. Scott S. Liu, Founder, Chairman, and CEO of HanchorBio, emphasized that head and neck cancer remains a significant burden for families in Taiwan. He noted that this clinical trial marks a major milestone in the development of HCB101, bringing new hope to patients who have exhausted standard treatment options. HCB101 works by targeting CD47 on cancer cells, thereby blocking the “don’t eat me” signal that suppresses immune attack. This restores innate immune cell phagocytosis of tumor cells and promotes antigen presentation to T cells, while combination with PD-1 inhibition further reinvigorates T cells to sustain anticancer immunity. If successful, HCB101 has the potential to become a critical therapeutic option across multiple cancer types.
HCB101 is a novel Fc-fusion SIRPα variant protein engineered to maximize immune activation while minimizing hematologic toxicity. Unlike traditional anti-CD47 monoclonal antibodies, HCB101 binds selectively to tumor-cell CD47 with low affinity for red blood cells, substantially reducing the risks of anemia and thrombocytopenia.
Scientific Rationale for Combination Therapy
In recurrent or metastatic head and neck cancers, PD-1 inhibitors alone achieve response rates of only about 20%, largely due to tumor-mediated immune evasion mechanisms. Preclinical animal studies have shown that dual blockade of CD47 and PD-1 improves the tumor immune microenvironment, enabling more robust and durable immune responses compared with monotherapy.
This trial is designed to overcome both innate and adaptive immune resistance, aiming to convert immunologically “cold” tumors into “hot” tumors and provide new treatment options for patients with limited alternatives.
Resource: 漢康生技新藥HCB101在台完成首位頭頸癌病人給藥 臨床順利推進
