HanchorBio Earns Dual KSMO/FACO 2026 Recognition for HCB101 and HCB301
HCB101 gastric cancer data earned Best Poster recognition with 80% ORR at mid-dose levels; HCB301 oral presentation reported 38.1% disease control across advanced solid tumors
TAIPEI, SHANGHAI, and SAN FRANCISCO — September 7, 2026 — HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today announced clinical results from HCB101 and HCB301 presented at KSMO 2026—the 19th Annual Meeting of the Korean Society of Medical Oncology and 2026 International Conference—held in conjunction with the 14th International Conference of the Federation of Asian Clinical Oncology (FACO), in Seoul, South Korea.
HanchorBio received multiple forms of scientific recognition at the meeting. Among approximately 500 accepted poster abstracts, HCB101 gastric cancer data were selected as one of only 20 Best Poster Presentation Award recipients and one of only 10 abstracts chosen for a live Poster Discussion. Separately, excluding invited faculty and speakers, HCB301 was selected as one of only 12 oral presentations across the scientific program. HanchorBio also presented HCB101 HNSCC clinical data as an ePoster.
The presentations highlighted key milestones for HanchorBio’s proprietary FBDB™ platform: HCB101 as a macrophage-directed clinical foundation with emerging clinical activity across gastric cancer and HNSCC, and HCB301, a first-in-class trispecific immunotherapy, as the next step toward coordinated multi-axis immune modulation with a single molecule.
Alvin Luk, PhD, MBA, CCRA, President and Chief Medical Officer (Group) & CEO (USA) of HanchorBio, presented both the HCB101 gastric cancer Poster Discussion and the first-in-human HCB301 oral presentation.
“The recognition of both HCB101 and HCB301 at KSMO/FACO is important because it reflects two stages of the same strategy through our FBDB™ platform—from establishing macrophage-directed clinical activity with HCB101 to extending that biology into multi-axis immune modulation with HCB301,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “HCB101 is anchoring our clinical strategy, while HCB301 tests whether three distinct drivers of immune resistance can be addressed within a single engineered therapeutic molecule.”
HCB101 Strengthens 2L GC/GEJ as a Clinical Anchor
HCB101 is an engineered SIRPα–IgG4 Fc fusion protein designed to block the CD47–SIRPα innate immune checkpoint and re-engage macrophage-mediated antitumor activity.
In the ongoing HCB101-201 study (NCT06771622), 20 patients with second-line GC/GEJ were enrolled across HCB101 dose levels of 2.56–12 mg/kg in combination with ramucirumab plus paclitaxel. Among 15 efficacy-evaluable patients, the 5.12–8 mg/kg mid-dose cohorts achieved an ORR of 80.0%, with broad and deep tumor shrinkage observed across patients. The overall DCR was 93.3%.
For historical context, ramucirumab plus paclitaxel produced ORRs of approximately 26–28% in RAINBOW and RAINBOW-Asia. The depth and consistency of tumor shrinkage support continued development of HCB101 in second-line GC/GEJ.
In first-line HER2-positive gastric cancer, eight efficacy-evaluable patients treated with HCB101 plus trastuzumab, pertuzumab, and chemotherapy achieved an ORR of 75.0% and DCR of 100%.
HCB101 Expands into HNSCC with Durable Monotherapy and Combination Activity
HanchorBio also presented HCB101 data in recurrent or metastatic HNSCC, supporting its expansion as a rational setting beyond the gastric cancer clinical anchor.
In HCB101-101 monotherapy, a confirmed partial response with ~42% tumor reduction was observed at 5.12 mg/kg, with treatment continuing beyond 80 weeks at the data cutoff. A second patient achieved disease control for approximately 34 weeks, with additional disease stabilization observed in HNSCC and nasopharyngeal carcinoma.
In a Taiwan investigator-initiated combination study, 2 of 4 evaluable patients achieved objective responses (ORR 50%), including a complete response and a confirmed partial response, while all four achieved disease control at first assessment. Three remained on treatment beyond 16 weeks, including one beyond 48 weeks, with follow-up ongoing.
Together, the monotherapy durability and emerging combination activity support continued evaluation of HCB101 in PD-1- and EGFR-directed strategies.
HCB301 Advances Multi-Axis Immune Modulation into the Clinic
In an oral presentation at KSMO 2026, HanchorBio presented first-in-human clinical findings from the ongoing Phase 1 HCB301-101 study (NCT06487624). HCB301 opened the second of two selected oral presentation sessions at KSMO 2026.
HCB301 is a trispecific SIRPα–PD-L1–TGFβ fusion protein designed to coordinately address innate immune suppression, adaptive immune checkpoint signaling, and TGFβ-mediated immune exclusion within a single molecule. Preclinical data presented at KSMO showed antitumor activity across two in vivo models, including tumor control in an HNSCC model and 98.5% tumor growth inhibition in combination in a breast cancer model, further supporting the rationale for coordinated engagement of these interconnected immune pathways.
The oral presentation included 29 patients enrolled across the 0.3, 0.6, 0.9, and 1.2 mg/kg cohorts. Among 21 efficacy-evaluable patients, 8 achieved stable disease, corresponding to a DCR of 38.1%. Disease stabilization was observed across multiple solid tumor types, including hypopharyngeal carcinoma, hepatocellular carcinoma, colorectal cancer, cholangiocarcinoma, pelvic malignancy, and sarcoma, with the longest disease control exceeding four months.
The population was heavily pretreated, with a median of four prior systemic therapy lines. Safety findings, including hematologic and infusion-related events, informed protocol refinements, enhanced monitoring, and dose-management strategies as development continues.
“HCB301 asks a different question from conventional combination immunotherapy: can coordinated immune modulation be engineered into the molecule itself?” said Dr. Luk, who delivered the oral presentation. “What is encouraging is that we are already seeing disease stabilization across multiple tumor types during early dose escalation in a heavily pretreated population. These remain early Phase 1 data, but they support continued dose optimization as we work to define the therapeutic window and determine whether coordinated SIRPα–PD-L1–TGFβ targeting can translate into meaningful clinical benefit.”
A Repeatable FBDB™ Clinical Strategy
HCB101 established HanchorBio’s clinical foundation in macrophage-directed innate immunity. HCB301 extends that foundation into trispecific immunotherapy integrating innate, adaptive, and TGFβ-mediated immune biology.
Understand the biology → engineer the right architecture → generate clinical evidence → learn where the biology works → expand deliberately
About HCB101
HCB101 is an investigational engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s FBDB™ platform. HCB101 blocks CD47–SIRPα signaling to restore macrophage-mediated antitumor immunity and downstream de novo T-cell activation. It is being evaluated as monotherapy (NCT05892718) and in combination (NCT06771622) across solid and hematologic malignancies and holds U.S. FDA Orphan Drug Designation for gastric cancer.
About HCB301
HCB301 is an investigational trispecific CD47–PD-L1–TGFβ fusion protein designed to concurrently address innate immune suppression, adaptive checkpoint signaling, and TGFβ-mediated immune exclusion within a single molecule. It is being evaluated in the ongoing first-in-human Phase 1 HCB301-101 study (NCT06487624).
About HanchorBio
HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on inventing next-generation biologics for cancer and immune-mediated diseases using its proprietary FBDB™ platform. HanchorBio’s pipeline includes clinical-stage programs HCB101 and HCB301, next-generation trispecific program HCB303, and additional candidates across oncology and immune-mediated diseases.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the clinical development of HCB101 and HCB301, interpretation and potential significance of preliminary clinical findings, future clinical studies and development strategies, potential therapeutic characteristics of HanchorBio’s product candidates, and the capabilities and potential of the FBDB™ platform. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those described. Clinical findings, including preliminary results, may change as additional patients are enrolled, data mature, and analyses are completed. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.