HanchorBio Presents Phase 1 HCB101 Clinical Results at FACO 2025 Demonstrating Safety and Early Antitumor Activity
Friday, October 24, 2025
HanchorBio Inc., a biotechnology company specializing in next-generation immunotherapies, presented significant new data today at the 13th International Conference of the Federation of Asian Clinical Oncology (FACO 2025), held in Shanghai, Mainland China. At this prestigious scientific gathering, HanchorBio shared interim results from its ongoing Phase 1 study evaluating HCB101, a novel SIRPα-engineered Fc fusion protein designed to target the CD47-SIRPα interaction, a well-validated immune checkpoint relevant in multiple cancer types. The presentation highlighted favorable safety findings, robust receptor occupancy, and early signals of clinical efficacy, underpinning the company’s broader ambition to advance innovative immunotherapy treatments for high unmet medical needs in oncology.
The multicenter, multinational, open-label Phase 1 study (NCT05892718) enrolled 49 patients with advanced solid tumors or relapsed/refractory non-Hodgkin lymphoma across Taiwan, China, and the United States. Patients received escalating flat doses ranging from 0.08 mg/kg up to 18.00 mg/kg administered weekly. Key results as of July 10, 2025, show an excellent safety profile: only one dose-limiting toxicity (DLT), a transient grade 3 thrombocytopenia, was observed at the 2.56 mg/kg level. Importantly, no treatment-related severe anemia or cytopenias—common adverse events associated with prior CD47-targeting agents—occurred even at the highest tested doses. At doses of at least 1.28 mg/kg, more than 90% CD47 receptor occupancy was recorded, indicating strong target engagement. Two patients achieved confirmed partial responses, one each in head and neck squamous cell carcinoma and non-Hodgkin lymphoma, while multiple other patients maintained durable disease control.
These encouraging early outcomes distinguish HCB101 as a differentiated CD47-SIRPα immune checkpoint inhibitor. It is a 3.5th-generation, affinity-optimized fusion protein that leverages HanchorBio’s proprietary FBDB™ platform. HCB101 features a cytopenia-sparing design and strong antibody-dependent cellular phagocytosis (ADCP), aiming to both preserve safety and drive durable immune tumor responses. Across preclinical models, HCB101 demonstrated robust activity in over 80 patient-derived and cell-line-derived xenografts encompassing various solid and hematologic cancers. Clinically, besides observed monotherapy activity, the agent already showed a 100% confirmed partial response rate in combination with ramucirumab and paclitaxel for second-line gastric cancer, and strong efficacy signals in first-line triple-negative breast cancer and second-line head and neck squamous cell carcinoma in ongoing studies.
Scott Liu, Ph.D., Chairman, CEO, and Founder of HanchorBio, commented that the FACO 2025 presentation reflects the company’s sustained commitment to bringing transformative therapies to global oncology. Led by industry veterans with decades of experience in biologics development, HanchorBio is applying innovative protein engineering and AI-driven design to address the complex challenges of immune evasion in cancer. The successful demonstration of HCB101’s safety, pharmacokinetics, and initial efficacy proves the platform’s potential and has paved the way for advancing this product into expansion cohorts and combination trials with established cancer therapies.
Looking ahead, HanchorBio intends to proceed with expanded clinical evaluation of HCB101, both as monotherapy and in rational combinations, to maximize therapeutic benefit for patients facing cancers with high unmet medical needs. By addressing safety limitations seen with earlier CD47 inhibitors and broadening immune activation, HCB101 aims to reset the standard for CD47-targeted immune-oncology agents. HanchorBio’s success also contributes to the global profile of Asian biotech innovation, underscoring the region’s increasing role in advancing next-generation biologic drug discovery and development, especially in the competitive immuno-oncology sector.
