【TAIPEI, SHANGHAI, and SAN FRANCISCO, June 02, 2025】– 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.
The ongoing Phase 1 dose-escalation trial (NCT05892718) is evaluating HCB101, a differentiated (engineered) SIRPα-Fc fusion protein targeting CD47-SIRPα signaling pathway, in patients with advanced solid tumors or relapsed/refractory (R/R) non-Hodgkin lymphomas (NHLs). As of April 23, 2025, the study had enrolled 36 patients from the United States, Taiwan, and mainland China.
Key findings include:
oFavorable safety and tolerability across escalating doses
oHigh-level CD47 receptor occupancy in peripheral immune cells
oPartial responses were observed in patients with head and neck cancer (HNSCC) and NHL
Importantly, early signs of anti-tumor activity were observed. Six patients reported Stable Disease (SD) as the best response, one of which with ovarian cancer (1.28 mg/kg) exceeded 24 weeks of disease control. Two patients reported Partial Response (PR), one of which with HNSCC (5.12 mg/kg) initially exhibited a 27% reduction in the sum of diameters (SOD) for target lesions at week 8, which subsequently deepened to a confirmed PR with a 42% SOD reduction at week 16. Another confirmed PR was observed via PET imaging at week 8 in a patient with marginal zone lymphoma (8 mg/kg).
“We are honored to share the HCB101 Phase 1a data following our presentation at ASCO 2025,” said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. “HCB101 is the first engineered SIRPα-Fc fusion protein to show favorable safety, robust receptor occupancy, and signs of anti-solid-tumor efficacy in patients with advanced cancers – all as a monotherapy in a Phase 1a clinical setting. Unlike earlier CD47-targeting agents, HCB101 was specifically designed to overcome limitations related to on-target toxicities and dependency on combination therapies while exhibiting a drastically enhanced (~1000-fold greater than wild-type SIRPα-Fc fusion proteins) ability to block the “do not eat me” signal generated by CD47. The clinical responses observed in patients with advanced solid tumors and R/R NHL further validate HCB101’s potential as a best-in-class macrophage checkpoint immunotherapy. This milestone reinforces our conviction that HCB101 can serve as a foundational asset for next-generation combinations in both oncology and autoimmune diseases.”
The confirmed partial response in the NHL patient and the HNSCC patient marks a significant milestone for the HCB101 program, highlighting its therapeutic potential in both solid tumors and hematologic malignancies. Radiographic and pharmacodynamic evidence of response was presented during the poster session at ASCO on June 2, 2025.
Developed using HanchorBio’s proprietary FBDB™ platform, HCB101 is engineered to block the SIRPα-CD47 ‘don’t-eat-me’ signal and promote macrophage-mediated tumor phagocytosis without inducing red blood cell-related toxicity—a major hurdle for previous CD47 inhibitors. Repeat-dose preclinical studies confirmed no meaningful hematologic toxicity, which is consistent with the manageable safety profile observed to date in the clinic.
“We are highly encouraged by the preliminary efficacy signals, especially the partial response in a marginal zone lymphoma patient and a HNSCC patient, and multiple long-lasting stable diseases in patients with solid tumors such as head and neck, colon, and ovarian cancer,” said Lucy Yan, M.D., Ph.D., Chief Medical Officer of HanchorBio. “These results suggest that HCB101’s mechanism of action can translate into meaningful clinical benefit while avoiding the hematologic liabilities that have hindered other CD47 agents.”
Building on these promising findings, HanchorBio is actively advancing expansion cohorts, combination strategies, and global partnership discussions to accelerate the development of HCB101 and its FBDB™ platform.