HanchorBio Reports Head and Neck Cancer Data for HCB101, Including Durable Monotherapy Activity and Complete Response at Low Dose in Combination with PD-1
Findings support HCB101 as a differentiated innate immune backbone in PD1-based regimens
[Taipei, Shanghai, San Francisco | April 22, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today reported updated clinical observations in head and neck squamous cell carcinoma (HNSCC) across both monotherapy and combination settings for HCB101, its rationally engineered SIRPα-Fc fusion protein functioning as an innate immune checkpoint blockade.
In the ongoing HCB101-101 Phase 1 monotherapy study, early evidence of clinical activity was observed in head and neck cancer, including a confirmed partial response with approximately 42% tumor reduction and durability beyond 65 weeks in a heavily pretreated patient, together with additional disease controls across dose levels. These findings provide initial clinical support for the biological activity of CD47–SIRPα blockade in this disease.
Complementing the monotherapy trial, an investigator-initiated study in Taiwan evaluated HCB101 in combination with pembrolizumab in recurrent/metastatic HNSCC (NCT07136545). As of the latest data cutoff, 3 patients were evaluable for efficacy at the 1.28 mg/kg low dose level, with the combination achieving a disease control rate (DCR) of 100%, including:
- 1 complete response (CR)
- 1 partial response (PR)
- 1 stable disease (SD)
The complete response was confirmed following subsequent assessment demonstrating regression of the target lymph node to <10 mm in short axis, with no residual non-target lesions or new lesions, consistent with RECIST 1.1 criteria. The patient had initially been assessed as a partial response, with tumor reduction over time before meeting criteria for a complete response. While based on small patient numbers and early follow-up, the observation of a complete response in combination with the standard-of-care, together with durable activity in monotherapy, provides a consistent signal supporting the role of CD47–SIRPα blockade in HNSCC.
“These findings reinforce how we think about HCB101—not as a standalone checkpoint inhibitor, but as a combination backbone that can integrate into and enhance existing standards of care,” said Scott Liu, PhD, Founder, Chairman, and Chief Executive Officer of HanchorBio. “The CD47–SIRPα axis is a central driver of myeloid immune suppression. By targeting this pathway, HCB101 has the potential to complement PD-1 therapy and help convert immune activation into more effective and sustained antitumor responses, particularly in diseases like HNSCC, where current treatments remain insufficient.”
Head and neck cancer remains a challenging disease in clinical practice, where PD-1-based therapies have improved outcomes but still deliver limited response rates and durability for many patients, particularly in the recurrent or metastatic setting. “What matters in HNSCC is not just where patients respond, but whether those responses are deep and durable,” commented Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (USA) of HanchorBio. “The monotherapy data give us confidence that the mechanism is active, and the early combination data suggest that this activity can be further enhanced. Even in this small dataset, we are seeing responses deepen over time in a sub-optimal dose, which is exactly the type of signal we would want from a therapy designed to engage innate immunity alongside PD-1 blockade.”
The HNSCC data are consistent with HanchorBio’s broader development strategy of advancing HCB101 across multiple combination settings, with second-line gastric cancer as the lead registrational path and head and neck cancer representing a key expansion opportunity where the molecule’s combination profile and mechanism may provide meaningful clinical differentiation.
About HCB101
HCB101 is HanchorBio’s next-generation SIRPα–IgG4 Fc fusion protein designed to block the CD47–SIRPα innate immune checkpoint while reducing the hematologic toxicities seen with earlier CD47-directed therapies. Engineered using the Company’s FBDB™ platform and AI-assisted (AlphaFold) structural modeling, HCB101 is intended to preserve macrophage-mediated antitumor activity while reducing red blood cell binding. Its emerging safety, receptor occupancy, and pharmacologic profile support development as monotherapy and in combination across multiple solid tumor settings, including those with established standard-of-care regimens. Ongoing clinical development includes gastric, colorectal, head and neck, and triple-negative breast cancers.
These attributes support HCB101’s development as a differentiated innate immune checkpoint backbone with broad potential across solid tumors and hematologic malignancies.
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TPEx) is a global clinical-stage biotechnology company focused on immuno-oncology and immune-mediated diseases. The company is led by an experienced team with a proven track record in biologics discovery and global development, aiming to reshape the landscape of cancer therapies. HanchorBio’s proprietary Fc-based designer biologics (FBDB™) platform enables the design of multi-functional biologics with diverse targeting modalities, designed to activate both innate and adaptive immune pathways and overcome the current challenges of anti-PD1/L1 immunotherapies. The FBDB™ platform has delivered proof-of-concept data in several in vivo tumor animal models. HanchorBio is advancing a portfolio of innovative biologics designed to address significant unmet medical needs through differentiated molecular configurations in R&D and scalable CMC strategies.