International debut underscores emerging role for macrophage checkpoint therapy in gastric cancer, triple-negative breast cancer, and other hard-to-treat solid tumors

TAIPEI, SHANGHAI, AND SAN FRANCISCO, Dec. 11, 2025 /PRNewswire/ -- HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced that new clinical data from its flagship macrophage-checkpoint program, HCB101, has been selected for a mini oral presentation at the ESMO Immuno-Oncology Congress 2025 in London, United Kingdom. Only 26 abstracts were chosen for mini-oral presentation this year, marking a major milestone for HanchorBio as it delivers its first-ever oral presentation of clinical data at an international oncology congress, following its prior preclinical oral presentation of HCB101 at CSCO 2022.

HanchorBio Announces Oral Presentation of HCB101 at the ESMO Immuno-Oncology Congress 2025

The ESMO Immuno-Oncology Congress is Europe's premier meeting dedicated exclusively to immuno-oncology science, distinct from the broader ESMO Annual Congress. While the annual ESMO meeting spans all oncology disciplines, ESMO-IO focuses on immune mechanisms, translational innovation, and next-generation therapeutic strategies across innate and adaptive immunity.

Presentation Details:

Abstract ID: 242MO
Title: HCB101, a Differentiated SIRPα Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity Across Solid Tumors and Lymphoma
First Author: Dr. Fangling Ning, Affiliated Hospital of Binzhou Medical University
Date / Time: 11 December 2025 / 11:45 – 12:45 GMT
Location: Whittle Room, Queen Elizabeth II Centre, London
Presenter: Alvin Luk, PhD, MBA, CCRA - President & CMO (Group) and CEO (U.S.A.), TIME100 Health 2025 Honoree

"For nearly a decade, CD47 therapies were held back not by flawed biology but by flawed molecules, which struggled to balance safety and efficacy at the same time, especially in immunologically cold tumors," said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. "HCB101 was engineered from the ground up to solve that problem. Using AI-guided structural modeling, we identified three core mutations that reshape SIRPα's interaction with CD47, allowing us to combine the strengths of first- and second-generation approaches into a single, differentiated molecule. Being selected as one of only 26 mini-oral presentations at ESMO Immuno-Oncology reinforces the field's recognition of this effort and redefines the CD47 therapies. With its clean safety profile, strong target engagement, and early activity in cold tumors, HCB101 is emerging as a true macrophage-checkpoint backbone – much like the transformative PD-1/PD-L1 therapies that were based on T-cell checkpoint inhibition."

Key Findings Highlighted in the Mini-Oral

Monotherapy (HCB101-101; NCT05892718)

• Clean, cytopenia-sparing safety across 12 cohorts up to 36 mg/kg QW
• No bleeding events or immune-related toxicities, with the majority of treatment-related adverse events being Grade 1-2
• Linear PK (T_1/2 ~3 days) with receptor occupancy (RO) >99% at ≥8 mg/kg
• Durable antitumor activity, including confirmed PRs in:
  • HNSCC -Head and neck squamous cell carcinoma (~42% tumor regression, ≥32 weeks)
  • MZL - Marginal zone lymphoma (~89% tumor regression, ≥16 weeks)
• Stable disease ≥4-9 months across colorectal cancer (CRC), ovarian cancer, non-small cell lung cancer (NSCLC), and sarcoma
• Combination Therapy (HCB101-201; NCT06771622)
• Well-tolerated across gastric cancer (GC), triple-negative breast cancer (TNBC), CRC, and HNSCC
• No new safety signals across all evaluated combinations
• Cytopenias fully attributable to chemotherapy, not HCB101
• 2L GC:
  • 58.3% ORR (7/12) for all cohorts evaluated, 77.8% ORR (7/9) for mid-dose cohorts, and 100% DCR
  • Tumor shrinkage up to -78.2%
• 1L HER2+ GC: 33% ORR (1/3)
• 1L TNBC: 50% ORR (3/6) and 100% DCR

Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and Chief Executive Officer (U.S.A.) of HanchorBio, added, "The early efficacy signals from HCB101 are unusually compelling for this stage of development. In second-line GC, where standard therapy achieves an ORR of about 27%, HCB101 combinations exceed 78% ORR, achieve 100% disease control, and result in tumor reduction approaching -78%. These results are not incremental; they meaningfully exceed expectations and reflect robust macrophage checkpoint engagement. With clean safety and sustained receptor occupancy, the data give us confidence to anchor development in second-line disease and expand into first-line and perioperative settings where depth and durability of response matter most."

About HCB101: A Next-Generation SIRPα Fc-Fusion Protein

HCB101 is a 3.5^th-generation engineered SIRPα-Fc fusion protein with an intact IgG4 Fc backbone, developed using HanchorBio's FBDB™ platform to selectively target tumor CD47 while minimizing binding to red blood cells. This design avoids the anemia and thrombocytopenia that limited early anti-CD47 programs, while preserving potent macrophage activation and downstream T-cell engagement. Key differentiators include:

• Cytopenia-sparing safety up to 30-36 mg/kg
• Receptor occupancy (RO) >99% at clinically active exposures
• Strong macrophage and downstream T-cell activation
• Broad antitumor activity across >80 PDX/CDX models and multiple clinical tumor types
• Robust early combination efficacy in tumors that historically respond poorly to immunotherapy

Unlike earlier approaches, HCB101's safety, target selectivity, and RO profile support its use as a macrophage-checkpoint backbone – analogous to how PD-1/PD-L1 inhibitors function as foundational T-cell backbones in oncology. HCB101 is designed for broad combinability across established and emerging treatment modalities, including:

• Chemotherapy
• Antibody-drug conjugates (ADCs)
• Anti-PD-1/anti-PD-L1 checkpoint inhibitors
• Anti-VEGF inhibitors
• Anti-EGFR therapies
• Anti-HER2 regimens

This versatility positions HCB101 as a modular, next-generational immuno-oncology component capable of enhancing the efficacy of multiple therapeutic backbones across solid tumors and hematologic malignancies.

About HanchorBio

Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (TPEx: 7827) is a global biotechnology company specializing in immuno-oncology. It is led by an experienced team of pharmaceutical industry veterans with a proven track record in biologics discovery and international development, aiming to rewrite the landscape of cancer therapies. Committed to reactivating the immune system to fight diseases, the proprietary Fc-based designer biologics (FBDB™) platform enables the development of unique biologics with diverse multi-targeting modalities, unleashing both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 therapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By advancing breakthroughs in multi-functional, innovative molecular configurations in R&D and improving CMC manufacturing processes, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: https://www.hanchorbio.com/

Source: HanchorBio Inc. Related Stocks: Taiwan:7827