[Taipei, Shanghai, San Francisco | October 07, 2025] – HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies, today announced the successful completion of its latest Scientific Advisory Board (SAB) meeting. Chaired by Professor Mingyi Chen (UT Southwestern Medical Center), the SAB brings together global leaders from institutions such as The Ohio State University, University of Michigan, Tsinghua University, and National Taiwan University to review HanchorBio’s clinical progress, translational insights, and pipeline strategy across oncology and autoimmune diseases.
The SAB reviewed compelling new clinical data from HCB101, HanchorBio’s best-in-class, engineered SIRPα-Fc fusion, protein designed to overcome the limitations of earlier CD47 approaches. Key highlights included:
- Clinical progress: HCB101 Phase 1a monotherapy study (HCB101-101; NCT05892718) shows clean and manageable safety up to 30 mg/kg with durable partial responses, including in head and neck squamous cell carcinoma (HNSCC) and marginal zone lymphoma. Phase 1b/2a combination study (HCB101-201; NCT06771622) with different tumor cohorts demonstrates striking efficacy in 2L gastric cancer (GC), with 100% confirmed partial response (PR) rate at 5.12-8.0 mg/kg and regressions up to ~78% in total diameter, plus early signals in 1L triple-negative breast cancer (TNBC) and HNSCC, far exceeding historical benchmarks.
- Strategic path: SAB endorsed anchoring registrational strategy where HCB101’s selective CD47 blockade with strong antibody-dependent cellular phagocytosis (ADCP) is most compelling. This includes tumors characterized by strong macrophage involvement and immune evasion, with potential applications from advanced solid tumors to earlier curative-intent settings.
- Regulatory and visibility: Opportunities identified for orphan drug designation (ODD) filings and high-impact publications to establish HCB101 as the first CD47 program with clear, dose-dependent clinical efficacy.
- Pipeline innovation: Review of next-generation assets from HanchorBio’s proprietary multi-specific and immune-modulatory platforms, including:
- HCB302 (CD47 x PD-L1 x CSF-1), a tri-specific targeting tumor immune evasion and myeloid reprogramming.
- RDHCB206 (CD20 x CD47), a bispecific for B-cell driven autoimmune diseases.
“As someone who has studies the CD47-SIRPα axis for many years, I am very impressed by how HCB101 has been engineered to overcome the historic safety and efficacy limitations of this pathway,” said Distinguished Professor Yangxin Fu, M.D., Ph.D., Director of the Immuno-Oncology at Tsinghua University Basic Medical College. “By minimizing binding to red blood cells while retaining potent ADCP to CD47-expressing cancer cells, HCB101 has demonstrated the cleanest clinical safety profile observed to date, even at 30 mg/kg. Importantly, its ability to re-engage macrophages and bridge innate and adaptive immune responses makes it uniquely positioned as a backbone therapy for rational combination strategies in both oncology and autoimmune diseases.”
Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio added, “The SAB’s feedback underscores that HCB101 is not just safer than prior CD47 agents but also capable of delivering clear dose-dependent clinical efficacy, including confirmed responses in solid tumors. With our recent strategic collaboration with Shanghai Henlius and industry momentum highlighted by Genmab’s $8B acquisition of Merus for head and neck cancer assets, HanchorBio is positioned to be at the forefront of next-generation checkpoint innovation. Together with our expanding multi-specific pipeline, including HCB302, RDHCB206 and so on, we are advancing a differentiated portfolio designed to deliver first-in-class and best-in-class therapies to patients with difficult-to-treat cancers and autoimmune diseases.”
About HCB101: A Differentiated CD47-SIPRα Blockade
HCB101 is a 3.5th-generation, engineered SIRPα-Fc fusion protein developed on HanchorBio’s proprietary FBDB™ platform. Designed for selective CD47 blockade with low red blood cell (RBC) binding, HCB101 avoids the anemia and thrombocytopenia commonly associated with earlier CD47 antibodies, while preserving strong antibody-dependent cellular phagocytosis (ADCP) and innate-to-adaptive immune bridging.
Key Differentiators of HCB101:
- Enhanced safety: Demonstrates a cytopenia-sparing profile, with no dose-limiting toxicities observed up to 24 mg/kg and receptor occupancy >90% at ≥28 mg/kg, supporting a broad therapeutic window.
- Robust immune activation: Engineered to enhance ADCP and bridge innate-to-adaptive immunity, with evidence of durable immune-mediated tumor control in monotherapy.
- Broad tumor applicability: Demonstrated activity across >80 PDX and CDX preclinical models, with early clinical signals in gastric cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, non-Hodgkin lymphoma, and ovarian cancer.
- Clinical translation: Shows durable disease control as monotherapy and a 100% confirmed partial response rate (6/6) in second-line gastric cancer when combined with ramucirumab and paclitaxel, with additional confirmed responses in first-line TNBC, and second-line HNSCC, substantially exceeding historical benchmarks.