HanchorBio Presents Two ASCO 2026 Abstracts Highlighting HCB101 Combination Activity and HCB301 First-in-Human Clinical Progress
Data support HCB101 as a differentiated innate immune checkpoint backbone across monotherapy and standard-of-care combination settings
[Taipei, Shanghai, San Francisco | June 1, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced updated clinical data for HCB101 and HCB301 presented at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
The presentations highlight HanchorBio’s advancing clinical pipeline in innate immunity and multifunctional immuno-oncology. HCB101 is the Company’s differentiated SIRPα-IgG4 Fc fusion protein designed to block the CD47/SIRPα innate immune checkpoint while reducing hematologic liability. HCB301 is a first-in-class tri-specific fusion protein designed to coordinate modulation of CD47/SIRPα, PD-L1/PD-1, and TGF-β/TGFβ-R pathways within a single molecule.
“We believe the ASCO data further support HCB101 as a differentiated innate immune checkpoint backbone with broad combination potential,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “Using AlphaFold-guided structural modeling within our FBDB™ platform, we engineered HCB101 to enhance and sustain receptor occupancy while reducing the hematologic limitations that challenged earlier anti-CD47 molecules. The emerging clinical data across monotherapy and combination settings support HCB101’s potential for future registrational development.”
Key HCB101 Clinical Highlights Presented at ASCO 2026
In the ongoing HCB101-101 first-in-human Phase 1 monotherapy study, dose escalation has reached 36 mg/kg with manageable safety and no maximum tolerated dose identified. Across 67 treated patients, treatment-related adverse events were predominantly Grade 1–2, with no Grade 3 anemia observed.
HCB101 demonstrated durable monotherapy antitumor activity, including confirmed partial responses in:
- Head and neck squamous cell carcinoma with ~42% tumor reduction and durability beyond 68 weeks
- Marginal zone lymphoma with approximately 89% tumor reduction
- Eleven additional cases of durable stable disease across multiple tumor types
In the HCB101-201 multicohort combination study, HCB101 demonstrated encouraging activity across multiple standard-of-care regimens without compromising partner dosing or introducing unexpected overlapping toxicities.
In second-line gastric cancer, HCB101 combined with ramucirumab and paclitaxel achieved:
- Overall ORR of 57.1% (8/14)
- ORR of 80% in the mature mid-dose cohorts (5.12–8 mg/kg)
- Deep tumor regressions up to 78.2%
- Ongoing responses beyond 34 weeks
Additional combination signals included:
- 80% ORR and 100% DCR in first-line HER2-positive gastric cancer
- 50% ORR and 100% DCR in first-line triple-negative breast cancer
- A confirmed partial response in colorectal cancer
“The HCB101 data presented at ASCO represent one of the broadest clinical datasets reported to date for a macrophage checkpoint inhibitor across monotherapy and multiple combination settings,” said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “The HCB101-201 data in second-line gastric cancer support a clear development rationale for advancing HCB101 in combination with established standard-of-care therapy as a potential combination-enabling innate immune backbone for future registrational development.”
The HCB301 abstract presents first-in-human Phase 1 data supporting the clinical feasibility of coordinated modulation of innate, adaptive, and TGF-β pathways with a single molecule. As of February 2026, HCB301 demonstrated manageable safety, approximately linear PK, and early evidence of immune modulation in heavily pretreated patients with advanced solid tumors.
“We believe HCB301 represents an important next-generation evolution beyond conventional checkpoint combinations,” added Dr. Luk. “The ability to coordinate SIRPα, PD-L1, and TGF-β modulation within a single molecule may offer a differentiated strategy for immune-resistant tumors.”
ASCO 2026 Presentation Details
HCB101
Title: The differentiated SIRPα-IgG4 Fc fusion protein HCB101 in monotherapy and combination therapy
ID: 2655
Session: Developmental Therapeutics – Immunotherapy Poster Session
Poster Board: 445
Presentation Date / Time: May 30, 2026 / 13:30 – 16:40 CDT
HCB301
Title: First-in-human phase 1 evaluation of the world’s first tri-specific SIRPα-PD-1-TGF-β Fc fusion protein HCB301 in advanced solid tumors
ID: e14570
About HCB101
HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein designed to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity associated with earlier-generation CD47-targeted therapies. HCB101 is being evaluated as monotherapy and in combination with standard-of-care regimens across multiple tumor types, including gastric, colorectal, head-and-neck, and triple-negative breast cancers.
About HCB301
HCB301 is an investigational tri-specific fusion protein designed to simultaneously modulate the CD47/SIRPα, PD-L1/PD-1, and TGF-β/TGFβ-R pathways. The molecule is intended to simultaneously trigger innate immune activation, inhibit adaptive checkpoint pathways, and modulate the stroma in a single construct.
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.
Forward-Looking Statements
This press release contains forward-looking statements regarding HanchorBio’s clinical development programs, product candidates, regulatory strategy, and future plans. Actual results may differ materially from those expressed or implied due to various risks and uncertainties, including clinical development outcomes, regulatory decisions, and market conditions. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.