HanchorBio Presents Monotherapy and Combination Clinical Data for HCB101 at AACR Immuno-Oncology 2026
Monotherapy and multi-regimen combination data demonstrate a cytopenia-sparing safety profile, robust CD47 receptor occupancy, and encouraging dose-dependent antitumor activity
HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company pioneering transformative immunotherapies, today presented new clinical and translational data on HCB101, its differentiated SIRPα–Fc innate immune checkpoint fusion protein, at the American Association for Cancer Research (AACR) Immuno-Oncology Conference in Los Angeles. The presentation highlighted updated findings from the ongoing HCB101-101 Phase 1a monotherapy trial (NCT05892718) and the HCB101-201 Phase 1b/2a combination study (NCT06771622) across multiple tumor types and established oncology therapies.
The AACR Immuno-Oncology Conference is a focused international meeting dedicated exclusively to immuno-oncology science, convening leading academic investigators, translational researchers, and industry innovators to advance next-generation immune-based cancer therapies. Unlike broader oncology congresses, AACR-IO emphasizes mechanistic insights, translational strategies, and emerging clinical data across innate and adaptive immune pathways.
Presentation Details:
Application ID: 64087
Title: Phase 1 Monotherapy and Combination Data for HCB101, a Novel SIRPα-Fc Innate Checkpoint Fusion Protein
First Author: Dr. Fangling Ning, Affiliated Hospital of Binzhou Medical University
Date / Time: 19 February 2026 / 12:15 – 15:15 PT
Key Findings Highlighted
Phase 1a Monotherapy (HCB101-101; NCT05892718)
As of January 2026, 67 patients were enrolled across 13 dose levels (0.08 – 36 mg/kg QW):
- Clean, cytopenia-sparing safety across dose levels
- No bleeding events or immune-related toxicities; predominantly Grade 1-2 treatment-related adverse events
- 2 dose-limiting toxicities (thrombocytopenia), both resolved
- Maximum tolerated dose not reached
- Linear PK (t1/2 ~3 days) with receptor occupancy (RO) >99% at ≥8 mg/kg
- Antitumor activity, including confirmed partial responses in:
- Head and neck squamous cell carcinoma (~42% tumor regression, ≥32 weeks)
- Marginal zone lymphoma (~89% tumor regression, ≥16 weeks)
- Durable stable disease (≥4-9 months) across colorectal, ovarian, non-small cell lung cancer, and sarcoma
Combination Therapy (HCB101-201; NCT06771622)
HCB101 is being evaluated with chemotherapy, PD-1, anti-VEGF, HER2-targeted, and EGFR-based regimens. Across combination cohorts:
- Well-tolerated across gastric cancer (GC), triple-negative breast cancer (TNBC), colorectal cancer (CRC), and HNSCC
- No unexpected overlapping toxicities or new safety signals
- Cytopenias are primarily attributable to chemotherapy rather than HCB101
- 2L GC (Ramucirumab + Paclitaxel):
- ORR: 100% (5.12 mg/kg) and 81% (8 mg/kg)
- Disease control rate (DCR): 100% across dose levels
- Dose-dependent tumor shrinkage, with deepest reduction up to -78.2%
- 1L GC (HER2+ backbone): ORR up to 100% in early cohorts; DCR 100%
- 1L TNBC: ORR up to 67% in early cohorts; DCR 100%
“Across both monotherapy and combination settings, HCB101 is demonstrating a consistent and differentiated clinical profile – cytopenia-sparing safety, sustained receptor occupancy, and early dose-dependent activity signals,” said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “The observed activity, particularly in combination regimens, strengthens our confidence in positioning HCB101 as a macrophage-checkpoint backbone. Our objective is not incremental refinement of CD47 biology but to establish a reliable innate immune foundation that integrates seamlessly with established oncology standards of care. The data presented at AACR-IO reinforce that direction and provide a strong basis for ongoing Phase 2 development in tumor types with high unmet need.”
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 achieves 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 designed to enable integration 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 as both monotherapy and in combination, including in tumor types historically challenging for CD47-directed therapies. Dose escalation and Phase 2 expansion cohorts in gastric, colorectal, and head and neck 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, with the aim of reshaping 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.