[TAIPEI, SHANGHAI, and SAN FRANCISCO, July 17, 2025] –HanchorBio Inc. (7827.TWO), a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, today announced that the Taiwan Food and Drug Administration (TFDA) has approved a third investigator-initiated trial (IIT) evaluating HCB101 in combination with zolbetuximab and chemotherapy for the first-line treatment of patients with HER2-negative, CLDN18.2-positive advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study will be conducted at Kaohsiung Medical University Chung-Ho Memorial Hospital under the leadership of Dr. I-Chen Wu and Dr. Li-Tzong Chen, and at China Medical University Hospital, led by Dr. Li Yuan Bai.
This latest TFDA approval follows earlier IIT approvals in colorectal and head and neck cancers. It represents another milestone in HanchorBio’s commitment to advancing novel and potentially efficacious immunotherapy combinations across difficult-to-treat solid tumors with high unmet needs.
“This TFDA approval is particularly meaningful to us, not only because gastric cancer remains a significant challenge in Asia, but because it shows how far we have come in building a platform that blends science with heart,” said Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio. “It’s especially rewarding to see this trial, along with our other TFDA-approved IITs, being conducted in some of Taiwan’s top research-oriented general hospitals. These studies reflect our broader mission to bring HCB101 to patients across Asia, supported by professional clinical partnerships and the strong momentum from our recent listing on the Emerging Stock Market of the Taipei Exchange. With this gastric cancer trial, we are expanding the potential of HCB101 into another area of unmet medical need, where engineered immune modulation could truly make a difference.”
About the Investigator-Initiated Trial in Advanced Gastric Cancer
The open-label, dose-escalation, and dose-expansion trial (HCB101-IIT-GC-202501) is designed to evaluate the safety, tolerability, and preliminary efficacy of HCB101 in combination with zolbetuximab and chemotherapy in patients with HER2-negative, CLDN18.2-positive advanced or metastatic gastric or GEJ adenocarcinoma who have progressed following prior standard therapy.
Patients will receive:
•HCB101 administered intravenously every week,
•Zolbetuximab administered every 3 weeks with 800 mg/m2 on Day 1 of Cycle 1, followed by 600 mg/m2 on Day 22 and in subsequent cycles (Days 1 and 22) in combination with mFOLFOX6,
•Chemotherapy consists of either:
omFOLFOX6: up to 12 cycles of oxaliplatin, leucovorin, and 5-FU every 2 weeks, or
oCAPOX: up to 8 cycles of oxaliplatin plus oral capecitabine every 3 weeks.
The investigator will select the chemotherapy backbone based on the patient’s prior treatment history. Patients who do not progress after 4 cycles of mFOLFOX6 will continue zolbetuximab plus fluoropyrimidine and folinic acid at the investigator’s discretion.
HCB101 + Zolbetuximab + Chemotherapy: Combination Rationale
HCB101 is an engineered SIRPα fusion protein developed through AI-assisted structural modeling and large-scale screening of a phage library containing 108 different SIRPα variants. It is designed to selectively and effectively block the CD47-SIRPα “don’t eat me” signal, enhancing macrophage phagocytosis and adaptive immune priming while maintaining a desirable safety profile. Preclinical data suggest that CD47 blockade can synergize with antibody-based and chemotherapy regimens to enhance inhibition of tumor growth while potentially reducing the hematologic toxicity. Zolbetuximab is a CLDN18.2-targeted monoclonal antibody approved in multiple regions for the treatment of gastric cancer, functioning through both ADCC and CDC mechanisms. Chemotherapy (mFOLFOX6 or CAPOX) provides the cytotoxic backbone to drive antigen release and tumor debulking.
The triplet combination is designed to simultaneously target:
•Innate immune suppression (via CD47 blockade with HCB101),
•Tumor-specific antigen engagement (via CLDN18.2 with zolbetuximab), and
•Tumor burden reduction (via cytotoxic chemotherapy).
This coordinated approach provides a rational strategy to overcome the immunologically “cold” tumor microenvironment seen in CLDN18.2-positive gastric cancer and achieve stronger, more durable anti-tumor responses.
About HCB101: A Differentiated CD47-SIPRα Blockade
HCB101 is a potential best-in-class Fc-fusion SIRPα variant designed to optimize immune activation while minimizing hematologic toxicity. Unlike traditional anti-CD47 monoclonal antibodies, HCB101 exhibits selective tumor engagement with low binding to red blood cells (RBCs), thereby reducing the risk of anemia and thrombocytopenia commonly associated with other CD47-targeting agents.
Key Differentiators of HCB101:
•Enhanced safety profile: Reduced RBC depletion compared to traditional CD47-targeting agents.
•Synergistic immune activation: Strongly enhanced ADCP, bridging innate and adaptive immune responses to drive durable anti-tumor immunity.
•Broad tumor applicability: Demonstrated activity in over 80 CDX and PDX preclinical models across multiple solid tumors and hematological malignancies.
•Early signs of clinical efficacy: At the 2025 ASCO Annual Meeting, it was reported that HCB101 monotherapy demonstrated confirmed partial responses in two patients (one with HNSCC and one with marginal zone lymphoma) and stable disease in six additional heavily pretreated patients, including prolonged disease control exceeding 40 weeks in a patient with ovarian cancer. These findings provide early clinical evidence of long-lasting antitumor activity.
HCB101 is currently being evaluated in multiple clinical trials, including:
•HCB101-101 (NCT05892718): A Phase 1 open-label, multi-regional, multi-center, dose-finding, first-in-human monotherapy trial of HCB101 in advanced solid tumors or relapsed and refractory non-Hodgkin lymphomas.
•HCB101-201 (NCT06771622): A Phase 1b/2a open-label, multi-regional, multi-center trial of HCB101 in combination with standard-of-care therapies in multiple advanced solid tumors.
•HCB101-IIT-CRC-202401: An open-label, dose-escalation, and dose-expansion investigator-initiated trial of HCB101 in combination with cetuximab or bevacizumab and chemotherapy regimens in RAS/BRAF wild-type advanced or metastatic colorectal cancer.
•HCB101-IIT-HNSCC-202401: A non-randomized, open-label, dose-escalation, and dose-expansion investigator-initiated trial of HCB101 in combination with pembrolizumab in patients with cisplatin-refractory, recurrent or metastatic head and neck squamous cell carcinoma (SirH&N Trial).
•HCB101-IIT-GC-202501: An open-label study to evaluate safety, tolerability, and antitumor activity of HCB101 in combination with multiple agents in subjects with advanced gastric or gastro-esophageal (GEJ) adenocarcinoma.