HanchorBio Reports Early Taiwan IIT Signal in 2L CRC With Sustained Disease Control Beyond 37 Weeks
Early investigator-initiated data support continued evaluation of HCB101-based combinations in second-line colorectal cancer
[Taipei, Shanghai, San Francisco | April 3, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced early findings from an ongoing investigator-initiated trial (IIT) in Taiwan evaluating HCB101-based combination therapy in patients with second-line colorectal cancer (CRC).
The Taiwan IIT is an open-label Phase 1b/2a study evaluating HCB101 in combination with standard second-line treatment regimens in patients with unresectable locally advanced or metastatic colorectal cancer. The protocol includes weekly HCB101 in combination with investigator-selected bevacizumab or cetuximab together with FOLFOX or FOLFIRI, based on prior treatment history. Eligible patients are adults with histologically or cytologically confirmed advanced CRC who are RAS wild-type and BRAF wild-type and have failed prior chemotherapy for locally advanced or metastatic disease.
The first three evaluable second-line CRC subjects treated in this Taiwan IIT have been assessed to date. Among these three subjects, all achieved stable disease as the best observed response, and two remained on treatment with sustained disease control for more than 37 weeks (7.1 months). Based on treatment records, one subject received HCB101 in combination with bevacizumab and mFOLFOX6, and a second subject received HCB101 in combination with bevacizumab and FOLFIRI. Both subjects remained on therapy for approximately 10 cycles, with repeated stable disease assessments over time. A third subject initially achieved stable disease but came off study earlier. These early subject-level observations suggest potentially durable disease control in a difficult-to-treat second-line CRC setting.
“The design logic behind this CRC IIT is highly consistent with the biology of HCB101,” said Scott Liu, PhD, Founder and Chairman of HanchorBio. “HCB101 is engineered to block the CD47-SIRPα innate immune checkpoint while preserving hematologic tolerability, making it well-suited for combination development with established antibody- and chemotherapy-based regimens. In colorectal cancer, combining HCB101 with bevacizumab or cetuximab and standard chemotherapy is intended to enhance macrophage-mediated antitumor activity within a treatment regimen already familiar to physicians. These early Taiwan IIT findings are encouraging because they suggest that innate immune checkpoint modulation may help extend disease control in a setting where durable benefit remains challenging to achieve.”
Although survival data remain limited and cross-trial comparisons should be interpreted cautiously, the observed treatment durations appear promising compared to published second-line benchmark studies. In ML18147, bevacizumab combined with switched chemotherapy after initial progression was evaluated in 820 patients and showed a median overall survival (mOS) of 11.2 months; subgroup analyses also reported a median progression-free survival (mPFS) of about 6.4 months in the bevacizumab arm (Bennouna J et al., Lancet Oncology 2013). In RAISE, ramucirumab with FOLFIRI was studied in 1,072 patients and demonstrated mPFS of 5.7 months and mOS of 13.3 months (Tabernero J et al., Lancet Oncology 2015). In the extended RAS wild-type analysis of EPIC, cetuximab plus irinotecan was assessed in a 452-patient molecularly selected subgroup, with median PFS of 5.4 months and median OS of 12.3 months (Sobrero A et al., Oncologist 2021).
“Second-line metastatic colorectal cancer remains an area of high unmet medical need, even with currently available biologic and chemotherapy options,” said Alvin Luk, PhD, MBA, CCRA, President and Chief Medical Officer (Group) of HanchorBio. “In this early Taiwan IIT experience, seeing two of the first three subjects remain on treatment with sustained disease control through more than 37 weeks is clinically notable. We believe treatment duration and ongoing disease control are the most appropriate ways to describe these early findings, particularly while survival data remain immature. Although these observations are preliminary and hypothesis-generating, they support continued clinical evaluation of HCB101-based combinations in colorectal cancer.”
The Taiwan IIT is intended to explore the safety, tolerability, pharmacology, and preliminary antitumor activity of HCB101 in rational combination regimens relevant to second-line CRC practice in Taiwan. HanchorBio believes investigator-sponsored clinical experience can provide important translational insight into where innate immune checkpoint modulation may add value within established treatment paradigms.
About the Taiwan CRC IIT
The ongoing Taiwan CRC IIT is an open-label Phase 1b/2a study evaluating HCB101-based combination therapy in adults with unresectable locally advanced or metastatic colorectal cancer. Eligible patients are RAS wild-type and BRAF wild-type and must have failed prior chemotherapy for advanced disease. Under the protocol, HCB101 is administered weekly in combination with investigator-selected bevacizumab or cetuximab, with backbone selection based on prior treatment history, and administered with FOLFOX or FOLFIRI. The study is designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity in a second-line treatment setting.
About HCB101
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 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.