{"id":2438,"date":"2026-06-10T07:00:33","date_gmt":"2026-06-09T23:00:33","guid":{"rendered":"https:\/\/www.hanchorbio.com\/?post_type=news&p=2438"},"modified":"2026-06-08T14:52:02","modified_gmt":"2026-06-08T06:52:02","slug":"hanchorbio-presents-late-breaking-data-at-focis-2026-supporting-innate-immune-product-engine-across-oncology-and-autoimmune-disease","status":"publish","type":"news","link":"https:\/\/www.hanchorbio.com\/en\/news\/hanchorbio-presents-late-breaking-data-at-focis-2026-supporting-innate-immune-product-engine-across-oncology-and-autoimmune-disease\/","title":{"rendered":"HanchorBio Presents Late-Breaking Data at FOCIS 2026 Supporting Innate-Immune Product Engine Across Oncology and Autoimmune Disease"},"content":{"rendered":"

HanchorBio Presents Late-Breaking Data at FOCIS 2026 Supporting Innate-Immune Product Engine Across Oncology and Autoimmune Disease<\/strong><\/h2>\n

HCB101 clinical validation anchors platform expansion into multi-checkpoint immuno-oncology and B-cell-driven autoimmune disease<\/em><\/h3>\n

\u00a0<\/em><\/p>\n

[Taipei, Shanghai, San Francisco<\/strong> | June 9, 2026<\/strong>] \u2013 HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the presentation of late-breaking clinical and translational data at the Federation of Clinical Immunology Societies Annual Meeting, FOCIS 2026, being held June 9-12, 2026, in San Francisco.<\/p>\n

 <\/p>\n

The presentation highlights HanchorBio\u2019s SIRP\u03b1-based immune engineering platform across three programs: HCB101, targeting the CD47\/SIRP\u03b1 axis, HCB301, targeting CD47\/SIRP\u03b1, PD-L1\/PD-1, and TGF-\u03b2\/TGF\u03b2-R pathways, and HCB206, targeting CD20 while engaging CD47\/SIRP\u03b1 biology. The data support HanchorBio\u2019s strategy to build an innate-immune product engine capable of generating differentiated therapeutic candidates across oncology and autoimmune disease.<\/p>\n

 <\/p>\n

\u201cFOCIS is an important venue because it allows us to present the immunology behind our platform,\u201d said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio<\/strong>.\u00a0 \u201cOur strategy begins with HCB101, where monotherapy data have validated the molecule, and combination-therapy data are defining the clinical development path. From that foundation, we are extending the same SIRP\u03b1-based engineering logic into HCB301 for coordinated multi-checkpoint immune reprogramming and HCB206 for B-cell-driven autoimmune diseases.\u201d<\/p>\n

HCB101 is HanchorBio\u2019s lead clinical-stage SIRP\u03b1-IgG4 Fc fusion protein targeting the CD47-SIRP\u03b1 innate immune checkpoint. In the ongoing HCB101-101 Phase 1 monotherapy study (NCT05892718), dose escalation reached 36 mg\/kg with manageable safety and no maximum tolerated dose identified. In 67 treated patients, treatment-related adverse events were predominantly Grade 1\u2013<\/strong>2, with only 1 case of Grade 3 anemia. Durable monotherapy activity included confirmed partial responses in head and neck squamous cell carcinoma (with ~42% tumor reduction and durability beyond 69 weeks) and marginal zone lymphoma (with ~89% tumor reduction by Week 16), as well as 11 additional cases of durable stable disease.<\/p>\n

In combination development, HCB101 is being advanced as the lead clinical anchor in second-line gastric cancer. In the ongoing HCB101-201 combination multi-cohort study (NCT06771622), HCB101 combined with ramucirumab and paclitaxel achieved an overall objective response rate (ORR) of 57.1%, including an 80% ORR in the mature mid-dose cohorts of 5.12 and 8 mg\/kg, with deep tumor regressions up to 78.2%. Additional clinical signals, including a confirmed partial response in colorectal cancer with HCB101 and bevacizumab plus FOLFIRI and a confirmed complete response in HNSCC with HCB101 and pembrolizumab, support potential expansion across selected myeloid-dominant tumor settings.<\/p>\n

 <\/p>\n

At FOCIS 2026, HanchorBio also presented translational data showing that HCB101 remodeled the tumor immune microenvironment in vivo<\/em> by increasing tumor-infiltrating leukocytes and macrophages, shifting macrophage polarization toward an M1-dominant phenotype, and enhancing CD4+ and CD8+ T-cell infiltration and activation.<\/p>\n

 <\/p>\n

\u201cHCB101 is the clinical proof point for our platform,\u201d said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio<\/strong>. \u201cThe monotherapy data established safety, pharmacology, receptor occupancy, and early antitumor activity. The combination-therapy data now position second-line gastric cancer as the lead validation path, with colorectal cancer supporting broader GI applicability and head and neck cancer supporting expansion into other myeloid-dominant tumor settings. This is how HCB101 evolves from a CD47-inhibiting molecule into a clinically usable innate immune backbone.\u201d<\/p>\n

 <\/p>\n

The FOCIS presentation also highlighted how HanchorBio is extending the HCB101 thesis into next-generation product candidates. HCB301, a tri-specific SIRP\u03b1-PD-L1-TGF-\u03b2 fusion protein, is designed to coordinate innate, adaptive, and stromal immune modulation within a single molecule. Updated early clinical data from the ongoing HCB301-101 Phase 1 study (NCT06487624) showed disease stabilization in heavily pretreated patients at initial dose levels, with predominantly low-grade, on-mechanism cytopenias and reversible hematologic events under active monitoring and mitigation.<\/p>\n

 <\/p>\n

HCB206, a SIRP\u03b1-CD20 fusion protein, extends the platform into B-cell-driven autoimmune disease. In preclinical studies presented at FOCIS, HCB206 demonstrated picomolar-range B-cell cytotoxicity and enhanced activity in primary B cells from SLE patients. In an SLE patient-derived PBMC-engrafted humanized mouse model, HCB206 induced greater than 90% depletion of splenic CD19+ B cells and rapid suppression of serum anti-dsDNA IgG within seven days, while showing negligible erythrocyte phagocytosis and minimal platelet uptake.<\/p>\n

 <\/p>\n

Together, the data support HanchorBio\u2019s view that selective SIRP\u03b1-based engineering can serve as a programmable innate-immune backbone and product engine, beginning with HCB101 in oncology and expanding into multi-checkpoint immuno-oncology and autoimmune diseases.<\/p>\n

 <\/p>\n

FOCIS 2026 Presentation Details<\/strong><\/h3>\n

Title:<\/strong> Clinical and translational validation of CD47-SIRP<\/em>\u03b1<\/em> engineering enables context-dependent immune circuit reprogramming across oncology and autoimmunity<\/em><\/p>\n

ID:<\/strong> 2384363<\/p>\n

Session:<\/strong> Immuno-Oncology Session<\/p>\n

Presentation Date \/ Time:<\/strong> June 9, 2026 \/ 5:15 PM \u2013 6:30 PM PST<\/p>\n

 <\/p>\n

About HanchorBio<\/strong><\/p>\n

Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TWSE) 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\u2019s proprietary Fc-based designer biologics (FBDB\u2122) 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\u2122 platform has delivered proof-of-concept data in several in vivo<\/em> 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.<\/p>\n

 <\/p>\n

Forward-Looking Statements<\/strong><\/p>\n

This press release contains forward-looking statements regarding HanchorBio\u2019s 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.<\/p>\n","protected":false},"excerpt":{"rendered":"

HanchorBio announced the presentation of late-breaking clinical and translational data at the Federation of Clinical Immunology Societies Annual Meeting, FOCIS 2026, being held June 9-12, 2026, in San Francisco.<\/p>\n","protected":false},"featured_media":2441,"template":"","news-category":[34,36],"class_list":["post-2438","news","type-news","status-publish","has-post-thumbnail","hentry","news-category-development-progress","news-category-events"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news\/2438","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news"}],"about":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/types\/news"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/media\/2441"}],"wp:attachment":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/media?parent=2438"}],"wp:term":[{"taxonomy":"news-category","embeddable":true,"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news-category?post=2438"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}