HanchorBio Outlines Global Strategy for Gastric Cancer Immunotherapy as HCB101 Advances Beyond Phase 1

HanchorBio Outlines Global Strategy for Gastric Cancer Immunotherapy as HCB101 Advances Beyond Phase 1

At the Early Clinical Trials Forum, HanchorBio highlights how clinical translation, translational biology, and multi-layered immunotherapies are shaping the future of oncology

TAIPEI, SHANGHAI, and SAN FRANCISCO — August 24, 2026 — HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today announced that Alvin Luk, PhD, MBA, CCRA, President and Chief Medical Officer (Group) and CEO (USA) of HanchorBio, presented the Company’s vision for the next phase of gastric cancer immunotherapy at the Early Phase Clinical Trials: Innovation and Precision Medicine Forum in Taichung, Taiwan.

Beyond Phase 1: Redefining Early Clinical Development in Oncology

Historically, Phase 1 studies aimed primarily to establish safety, identify dose-limiting toxicities, and define maximum tolerated doses. With the rise of targeted therapies, immune checkpoint inhibitors, and bispecific antibodies, early clinical development must answer broader strategic questions:

• Regimen Optimization: Identifying optimal dosing, schedule, and combination regimens.
• Patient Selection: Pinpointing patient populations most likely to benefit through biomarker strategies.
• Global Translation: Generating robust early translational evidence to support global pivotal development decisions.

HanchorBio’s HCB101 development exemplifies this evolution — leveraging early signals to guide registration-enabling global strategies.

HCB101: Clinical Validation in Gastric Cancer

HCB101 is an AI-guided, engineered SIRPα-IgG4 Fc fusion protein developed using HanchorBio’s proprietary FBDB™ (Fc-Based Designer Biologics) platform. Designed to block the CD47-SIRPα innate immune checkpoint and enhance macrophage-mediated anti-tumor activity, HCB101 promotes tumor-cell clearance, antigen processing, and downstream immune activation.

In the ongoing HCB101-201 multi-cohort combination study across selected solid tumors, middle-dose cohort data in second-line gastric cancer/gastroesophageal junction cancer demonstrated encouraging early clinical activity:

80% Overall Response Rate (ORR):  8 of 10 evaluable patients achieving partial responses.

100% Disease Control Rate (DCR): Observed at initial post-baseline imaging assessments.

These results directly inform HanchorBio’s advancement of HCB101 toward a globally aligned gastric cancer program.

Beyond PD-1: A Three-Layer Immunotherapy Paradigm

Recent clinical milestones — such as an individualized neoantigen mRNA cancer vaccine combined with PD-1 blockade — highlight a shift toward coordinated immune system engineering. HanchorBio views the future of oncology through an integrated, three-layer framework:

1. Immune Education (Neoantigen Vaccines): Teaching the immune system to recognize tumor-specific immune responses.
2. Immune Reinvigoration (PD-1 Blockade): Restoring and sustaining adaptive T-cell responses.
3. Immune Execution (HCB101/Innate Activation): Triggering macrophage-mediated tumor clearance, enhancing tumor antigen presentation, and broadening the immune response by inducing de novo tumor-reactive T-cell clones.

Designing Today for the Decisions of Tomorrow

“Early clinical development is no longer just about establishing tolerance — it is building the biological, clinical, and translational evidence needed to make decisive development moves,” said Dr. Luk. “For HCB101, our goal is to translate macrophage-directed biology into a meaningful global strategy for patients with gastric cancer and beyond.”

“Scientific breakthroughs are only meaningful when translated into therapies that reach patients worldwide,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “ HCB101 represents our commitment to advancing macrophage-directed immunotherapy from a biological concept into a disciplined, global clinical execution strategy.”

About HCB101

HCB101 is an investigational engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s proprietary FBDB™ platform. HCB101 blocks CD47–SIRPα signaling and is designed to enhance macrophage-mediated antitumor immunity. It is being evaluated as monotherapy (NCT05892718) and in combinations (NCT06771622) across solid and hematologic malignancies. HCB101 has received U.S. FDA Orphan Drug Designation for gastric cancer.

About HanchorBio

HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company dedicated to reinventing immunotherapies through its proprietary FBDB™ platform. By targeting innate and adaptive immune pathways, HanchorBio develops breakthrough biologics designed to overcome treatment resistance in oncology and immune-mediated diseases.

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.