HanchorBio Presents Early Frontline Triple-Negative Breast Cancer Data for HCB101 Combination at GBCC 2026

HanchorBio Presents Early Frontline Triple-Negative Breast Cancer Data for HCB101 Combination at GBCC 2026

Oral presentation highlights early clinical activity and triplet feasibility of HCB101 in combination with anti-PD-1 and nab-paclitaxel in advanced triple-negative breast cancer

[Taipei, Shanghai, San Francisco | April 23, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the first dedicated presentation of HCB101 clinical data from an ongoing study evaluating HCB101 in combination with anti-PD-1 and nab-paclitaxel in patients with advanced triple-negative breast cancer (TNBC) at the Global Breast Cancer Conference 2026 (GBCC 2026) in Seoul, Korea.

As of April 2026, HCB101 showed early clinical activity in frontline TNBC, with responses across dose levels and disease control in all 8 efficacy-evaluable patients. The combination achieved an objective response rate (ORR) of 37.5% and a disease control rate (DCR) of 100%, with no unexpected safety signals observed to date.

“These early TNBC findings strengthen our conviction that HCB101 can be developed as a differentiated innate immune backbone across combination settings,” said Scott Liu, PhD, Founder, Chairman, and Chief Executive Officer of HanchorBio. “TNBC is a difficult frontline setting where both biological relevance and combination fitness matter. We believe the macrophage- and myeloid-rich tumor microenvironment, together with the biology of the CD47–SIRPα axis, makes this an important setting in which to advance HCB101 as a combination backbone.”

Presentation Details:

Presentation ID:  MO1-4

Title: Early Clinical Activity of the Novel SIRPα-IgG4 Fc Fusion Protein HCB101 in Combination with Anti-PD-1 and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer

Session Name / Location: Immunotherapy / Room 5 (Art Hall)

Date / Time: 23 April 2026 / 08:30 – 09:45 KST

Key TNBC Findings Presented at GBCC 2026

The oral presentation highlighted early signs of clinical activity and disease control for HCB101 in frontline TNBC:

• In the ongoing HCB101-201 Phase 1b/2a combination study (NCT06771622), 8 patients in the frontline TNBC cohort were evaluable for efficacy as of April 2026.
• The combination achieved an ORR of 37.5% and a DCR of 100% in this early dataset.
• Responses were observed across dose levels, including 1 confirmed PR and 2 SDs at 2.56 mg/kg, and 2 PRs and 1 SD at 8 mg/kg. Tumor shrinkage in all PR patients continued with ongoing weekly treatment, with the deepest tumor reduction reaching up to -84%.
• At 12 mg/kg, 2 additional patients had achieved SD, with follow-up evaluations still pending.
• No unexpected safety signals had emerged, supporting the early feasibility of HCB101 in a frontline triplet setting

TNBC is characterized by a highly immunosuppressive tumor microenvironment with substantial macrophage and myeloid involvement, supporting the rationale for targeting the CD47–SIRPα innate immune checkpoint. Preclinical TNBC data presented in the deck further supported combining HCB101 with PD-1 blockade, showing dose-dependent antitumor activity in a PBMC-humanized MDA-MB-453 model. Together, the preclinical and early clinical findings support the development of HCB101 as an innate-immune backbone in frontline TNBC.

“What matters in frontline TNBC is whether a new mechanism can add real biological value to an established PD-1 plus chemotherapy regimen,” said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “The early signal presented at GBCC suggests HCB101 may have the potential to do that, with initial antitumor activity across dose levels and an emerging safety profile that appears compatible with triplet development. These findings support continued development of an innate plus adaptive triplet strategy in this disease.”

About HCB101

HCB101 is HanchorBio’s next-generation SIRPα–IgG4 Fc fusion protein designed to block the CD47–SIRPα innate immune checkpoint while reducing the hematologic toxicities seen with earlier CD47-directed therapies. Engineered using the Company’s FBDB™ platform and AI-assisted (AlphaFold) structural modeling, HCB101 is intended to preserve macrophage-mediated antitumor activity while reducing red blood cell binding. Its emerging safety, receptor occupancy, and pharmacologic profile support development as monotherapy and in combination across multiple solid tumor settings, including those with established standard-of-care regimens. Ongoing clinical development includes gastric, colorectal, head and neck, and triple-negative breast cancers.

These attributes support HCB101’s development as a differentiated innate immune checkpoint backbone with broad potential across solid tumors and hematologic malignancies.

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 is led by an experienced team with a proven track record in biologics discovery and global development, aiming to reshape the landscape of cancer therapies. HanchorBio’s proprietary Fc-based designer biologics (FBDB™) platform enables the design of multi-functional biologics with diverse targeting modalities, designed to activate both innate and adaptive immune pathways and overcome the current challenges of anti-PD1/L1 immunotherapies. The FBDB™ platform has delivered proof-of-concept data in several in vivo tumor animal models. HanchorBio is advancing a portfolio of innovative biologics designed to address significant unmet medical needs through differentiated molecular configurations in R&D and scalable CMC strategies.