HanchorBio Presents First Dedicated HCB101 Head and Neck Cancer Data in Oral Presentation at ICHNO 2026
Oral presentation marks the first HNSCC-focused clinical disclosure for HCB101 and underscores the indication’s strategic relevance for innate immune checkpoint development
[Taipei, Shanghai, San Francisco | March 20, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the first dedicated presentation of HCB101 clinical data in head and neck squamous cell carcinoma (HNSCC) in an oral presentation at ICHNO 2026 (the 10th International Congress on Innovative Approaches in Head and Neck Oncology), a joint ESTRO, EHNS, and ESMO congress, in Seville, Spain.
This first HNSCC-focused disclosure brings together an emerging monotherapy and a combination strategy for HCB101 in solid tumors, where clinical progress has been limited, and durable benefit remains difficult to achieve for many patients. The data presented support continued evaluation of HCB101 in HNSCC by showing early signs of antitumor activity and durability, while reinforcing the importance of CD47–SIRPα blockade in a disease characterized by persistent immune escape and substantial unmet need after current standard therapies.
The presentation highlighted emerging clinical findings from the ongoing HCB101-101 Phase 1a monotherapy study (NCT05892718), together with supportive early observations from an investigator-initiated study (SirH&N) in Taiwan. Taken together, these data reinforces the potential relevance of CD47-SIRPα blockade in HNSCC, a disease characterized by persistent immune escape, myeloid-driven immunosuppression, and substantial unmet medical need after current standard therapies.
“Head and neck cancer is exactly the kind of indication where biological mechanism, unmet medical need, and development practicality come together,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “With HCB101, we used AlphaFold-guided structural modeling within our FBDB™ platform to redesign the SIRPα molecule to enhance and sustain receptor occupancy while reducing the hematologic liability that limited earlier anti-CD47 molecules and restricted their use in combination with standard therapies. That differentiation is especially important in HNSCC, where PD-1 therapy has become an established standard of care, yet meaningful clinical response and durable benefit remain limited for many patients. We believe HCB101 is particularly relevant in this setting because CD47-SIRPα blockade addresses the myeloid component of immune resistance that PD-1 alone does not fully overcome. This provides a strong mechanistic rationale for combining HCB101 with PD-1 inhibitors to deepen and prolong adaptive immune responses, and with cetuximab to amplify macrophage-mediated antibody-dependent cellular phagocytosis (ADCP) through anti-EGFR-directed tumor opsonization.”
Presentation Details:
Presentation ID: 401
Title: First Durable Clinical Response to CD47-SIRPα Blockade in Head and Neck Squamous Cell Carcinoma: Results from the HCB101 Phase 1 Trial
Session Name / Location: New Approaches to Treatment / Palacio de Congresos y Exposiciones de Sevilla
Date / Time: 20 March 2026 / 15:15 – 16:15 CET
Key HNSCC Findings Presented at ICHNO 2026
The oral presentation highlighted emerging evidence of clinical activity and durability for HCB101 in HNSCC across both monotherapy and combination settings:
- In HCB101-101 Phase 1a monotherapy study (NCT05892718), one heavily pretreated HNSCC patient achieved a confirmed partial response (PR) with ~42% tumor reduction and durability beyond 53 weeks.
- Additional disease control was observed in head and neck cancer cohorts.
- Pharmacodynamic analyses showed sustained CD47 receptor occupancy, including near-complete receptor occupancy early after dosing in the responding HNSCC patient, supporting on-target pharmacodynamic activity.
- In a Taiwan IIT study (SirH&N), the first 3 recurrent/metastatic HNSCC patients treated with HCB101 plus pembrolizumab achieved 2 confirmed PRs (≥20 weeks durability) and 1 SD
- This corresponded to an ORR of 66.7% and a DCR of 100% in the small evaluable cohort.
- Best tumor shrinkage in the SirH&B study reached 68.1% at 1.28 mg/kg
The oral presentation also highlights why HNSCC may represent a strategically important development setting for HCB101. In addition to the underlying scientific rationale, HNSCC offers a well-established treatment framework that incorporates both checkpoint inhibitors and EGFR-directed therapy, supporting the development of these combinations. HanchorBio’s ongoing Phase 1b/2a studies include HNSCC cohorts evaluating HCB101 in combination with pembrolizumab and with cetuximab-containing regimens, consistent with the Company’s view that HCB101 may serve as an innate immune backbone that can be integrated into established standards of care.
“HNSCC remains a difficult disease in clinical practice because even when patients respond to PD-1-based therapy, durability is often limited and relapse can occur quickly,” said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “That is why these early HCB101 findings are meaningful. What is particularly encouraging is that we are seeing not only antitumor activity and early signs of durability, but also sustained receptor occupancy consistent with target engagement. Even in the small Taiwan combination experience generated at a sub-therapeutic HCB101 dose, we observed confirmed responses and meaningful tumor shrinkage. These data are preliminary and based on very small numbers, but they compare favorably with historical expectations in HNSCC and support continued development of HCB101 in this setting.”
About HCB101: A Next-Generation SIRPα Fc-Fusion Protein
HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s FBDB™ platform to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity. Unlike earlier anti-CD47 approaches, HCB101 is designed to preserve macrophage-mediated antitumor activity while reducing red blood cell binding, a limitation that historically constrained CD47-directed therapies.
Engineered using AI-assisted structural modeling, HCB101 is designed to achieve differentiated binding to CD47 on tumor cells while maintaining low affinity for CD47 on red blood cells. Its safety, receptor occupancy, and pharmacologic characteristics are intended to support development both as monotherapy and in combination with established oncology regimens without disrupting standard dosing or clinical workflows.
In ongoing clinical and translational evaluation, HCB101 has demonstrated sustained target engagement and early antitumor activity across monotherapy and combination settings, including in tumor types historically challenging for CD47-directed therapies. Dose escalation and Phase 2 expansion cohorts in gastric, colorectal, head-and-neck, and triple-negative breast cancers are ongoing.
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. For more information, please visit: https://www.HanchorBio.com
*Please note that the World Oncology Congress (WOC), originally scheduled for March 23-25, 2026, has been rescheduled to August 17-19, 2026. For further information, please visit: https://www.cancer-congress.org/scientific-information