HanchorBio Announces First Confirmed Partial Response in Colorectal Cancer Cohort of Ongoing HCB101-201 Combination Study

HanchorBio Announces First Confirmed Partial Response in Colorectal Cancer Cohort of Ongoing HCB101-201 Combination Study

Early colorectal cancer activity expands HCB101’s clinical signal beyond gastric and head and neck cancers, supporting its potential as a combination backbone in myeloid-rich solid tumors.

[Taipei, Shanghai, San Francisco | May 18, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the first confirmed partial response (PR) in the colorectal cancer (CRC) cohort of its ongoing clinical study evaluating HCB101 in combination with standard-of-care regimens (NCT06771622).

HCB101 is HanchorBio’s lead SIRPα–IgG4 Fc fusion protein designed to selectively block the CD47-SIRPα innate immune checkpoint while reducing the hematologic liabilities historically associated with earlier CD47-targeting approaches. The emerging colorectal cancer signal provides additional clinical evidence supporting HCB101’s potential as an innate-modulating combination backbone across solid tumors with myeloid-cell-rich tumor microenvironments.

In the ongoing colorectal cancer cohort, HCB101 has now demonstrated a first confirmed partial response in combination with standard-of-care therapy. In addition, durable disease control has been observed in the low-dose 2.56 mg/kg cohort of the Taiwan IIT (NCT07204574), with progression-free survival approaching 11 months in two out of 3 efficacy-evaluable patients. Additional patients in the low- to mid-dose cohorts in the HCB101 combination study have also shown preliminary stable disease (SD) signals.

The colorectal cancer cohort is evaluating HCB101 in second-line CRC in combination with established therapeutic regimens, including anti-VEGF and anti-EGFR agents such as bevacizumab, cetuximab, or ramucirumab, together with chemotherapy-based treatment. The study is designed to assess whether an innate immune checkpoint backbone through CD47-SIRPα blockade can enhance antitumor activity within clinically validated treatment frameworks.

The observation of activity in colorectal cancer builds on HanchorBio’s broader clinical development strategy for HCB101, which prioritizes tumor types where macrophage biology and myeloid-cell signaling may contribute to treatment resistance and tumor immune suppression. These include second-line gastric cancer, first-line HER2-positive or CLDN18.2-positive gastric cancer, second-line colorectal cancer, and first-line recurrent or metastatic head and neck cancer.

“HCB101’s first confirmed partial response in colorectal cancer is an important clinical milestone because it extends the program’s activity signal into another major solid tumor setting,” said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. “Our goal is not to develop HCB101 as a single-indication asset, but as a potential innate immune backbone that can be integrated with established standards of care across selected myeloid-rich tumors. We will continue to generate clinical data to define where HCB101 can deliver the greatest value for patients and future development partners.”

About HCB101

HCB101 is an AI-guided, structurally 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 development across the CD47 class. HCB101 is being evaluated across multiple clinical settings as both monotherapy and combination therapy.

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’s proprietary Fc-based designer biologics (FBDB™) platform enables the design of multi-functional biologics intended to modulate innate and adaptive immune pathways with structural control over safety, exposure, and manufacturability. HanchorBio is advancing a portfolio of differentiated biologics designed to address significant unmet medical needs through innovative molecular engineering and scalable CMC strategies.