HanchorBio's Novel CD47-SIRPα Therapeutic HCB101 Accepted for Publication in Prestigious Journal of Hematology & Oncology

• Prestigious peer-review validates HCB101's differentiated mechanism and translational strength.
• Clinical data show a nearly 90% partial response rate in 2L gastric cancer (combo) and safe escalation to 30 mg/kg (mono)

TAIPEI, SHANGHAI and SAN FRANCISCO, Oct. 23, 2025 /PRNewswire/ -- HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies, today announced that its manuscript describing the discovery and preclinical development of HCB101, an engineered SIRPα-Fc fusion protein, has been published in the Journal of Hematology & Oncology (SCI Impact Factor 40.4; for reference, leading journals in the field of immuno-oncology include Journal of Clinical Oncology (impact factor 41.9), The Lancet Oncology (35.9), and Nature Cancer (28.5)).

The publication, titled "HCB101: A Novel Potent Ligand-Trap Fc-fusion Protein Targeting the CD47-SIRPα Pathway with High Safety and Preclinical Efficacy for Hematological and Solid Tumors," describes the rational protein engineering that enabled HCB101 to restore macrophage-mediated phagocytosis and bridge innate and adaptive immune responses while reducing red blood cell binding. In preclinical studies, HCB101 showed broad activity across more than 80 xenograft and PDX tumor animal models with a safety profile that differs from first- and second-generation CD47-targeting agents.

Notably, a US competitor focusing on CD47/SIRPα published findings in JHO in November 2020, reporting on a third-generation anti-CD47–SIRPα therapy. This underscores the journal's strong recognition within the field. The continued publication of anti-CD47 biologics in JHO highlights both the scientific importance of ongoing advancements and the journal's role as a leading international platform for preclinical and translational research on anti-CD47 therapies.

"Publication in the Journal of Hematology & Oncology affirms the scientific rigor and innovation behind HCB101 and emphasizes its differentiated preclinical foundation," said Scott Liu, PhD, Chairman, CEO, and Founder of HanchorBio. "Importantly, these insights are being directly translated into clinical studies: combined with standard-of-care, HCB101 has demonstrated a clear dose-dependent efficacy profile in 2L gastric cancer, culminating in a nearly 90% partial response rate at 5.12 and 8.0 mg/kg. In parallel, we have now escalated monotherapy dosing to 30 mg/kg without safety concerns. These milestones highlight HCB101's potential to serve as a backbone immunotherapy across solid tumors and hematologic malignancies and lay the groundwork for expanding into autoimmune indications where CD47-SIRPα biology is also potentially useful in creating a new B-cell depletion therapy."

Clinical Progress Strengthens Differentiated Best-in-Class Profile
HCB101 is currently being evaluated in multinational Phase 1 and Phase 1b/2a trials:

• Monotherapy (HCB101-101, NCT05892718):
  The Safety Review Committee (SRC) has reviewed the safety data up to 30 mg/kg weekly and found no dose-limiting toxicities, confirming a wide therapeutic window. Early signs of efficacy included two confirmed partial responses (PRs) in head and neck squamous cell carcinoma and marginal zone lymphoma, along with stable disease (SD) in nine patients, including over 40 weeks of disease control in platinum-resistant ovarian cancer.

• Combination (HCB101-201, NCT06771622):
  In the triplet regimen for 2L-gastric cancer (HCB101 + ramucirumab + paclitaxel), emerging activity was first observed at 2.56 mg/kg, where evaluable patients achieved SD with modest tumor shrinkage, averaging a 6% reduction in tumor size in the dose cohort. At 5.12 mg/kg, all three evaluable patients achieved confirmed PRs (33%–46% tumor reductions). At 8.0 mg/kg, all three evaluable patients have now achieved confirmed PRs (tumor shrinkage up to -78%) after extended follow-up. Together, these results represent a nearly 90% confirmed response rate (6 of 7 patients) at ≥ 5.12 mg/kg dose level — a striking outcome in a setting where the typical overall response rate (ORR) for the SOC is only 26.5%.

"The data now published in JHO validate the design strategy that made HCB101 possible – balancing high efficacy with a clean safety margin where earlier CD47-targeting agents failed," added Wenwu Zhai, PhD, Chief Scientific Officer of HanchorBio. "Seeing those preclinical insights translate into durable monotherapy activity and remarkable combination dose-dependent responses in gastric cancer provides confidence not only for oncology but also for new areas such as autoimmunity. HCB101's differentiated mechanism and safety profile open the door to rational combinations and next-generation applications well beyond cancer."

About HCB101: A Differentiated CD47-SIPRα Blockade
HCB101 is a 3.5^th-generation, affinity-optimized SIRPα-Fc fusion protein with intact IgG4 effector function, developed using HanchorBio's proprietary FBDB™ platform. Engineered for selective CD47 blinding on tumors with low affinity for red blood cells, HCB101 avoids the hematologic toxicities commonly associated with anti-CD47 monoclonal antibodies, while preserving strong antibody-dependent cellular phagocytosis (ADCP) and innate-to-adaptive immune bridging.

Key Differentiators of HCB101:

• Enhanced safety: Low RBC binding minimizes anemia and thrombocytopenia risk.
• Robust immune activation: Engineered to enhance ADCP and innate-to-adaptive bridging.
• Broad tumor applicability: Demonstrated activity in >80 PDX/CDX preclinical models.
• Clinical translation: Early efficacy as monotherapy with durable disease control, and 100% ORR and disease control rate (DCR) at the middle dose cohort in combination with standard-of-care for 2L-gastric cancer.

About HanchorBio

Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TPEx), a global biotechnology company specializing in immuno-oncology, is led by an experienced team of pharmaceutical industry veterans with a proven track record of success in biologics discovery and international development, aiming to rewrite 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 making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: www.HanchorBio.com

SOURCE HanchorBio Inc.