{"id":2356,"date":"2026-04-03T10:00:49","date_gmt":"2026-04-03T02:00:49","guid":{"rendered":"https:\/\/www.hanchorbio.com\/?post_type=news&p=2356"},"modified":"2026-04-09T09:12:44","modified_gmt":"2026-04-09T01:12:44","slug":"hanchorbio-signals-backbone-potential-for-hcb101-as-sab-aligns-on-gastric-cancer-registrational-path","status":"publish","type":"news","link":"https:\/\/www.hanchorbio.com\/en\/news\/hanchorbio-signals-backbone-potential-for-hcb101-as-sab-aligns-on-gastric-cancer-registrational-path\/","title":{"rendered":"HanchorBio Signals \u201cBackbone\u201d Potential for HCB101 as SAB Aligns on Gastric Cancer Registrational Path"},"content":{"rendered":"

HanchorBio Signals \u201cBackbone\u201d Potential for HCB101 <\/strong>as SAB Aligns on Gastric Cancer Registrational Path<\/strong><\/h2>\n


\n<\/strong>Emerging combination profile positions CD47 program alongside next-generation IO deal assets; platform expands beyond oncology into autoimmune, atherosclerosis, and CNS delivery<\/em><\/h3>\n

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[Taipei, Shanghai, San Francisco<\/strong> | April 3, 2026<\/strong>] \u2013 HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies, reported outcomes from its recent Scientific Advisory Board (SAB) meeting, highlighting a shift from platform validation to asset-level positioning and registrational strategy.<\/p>\n

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Across updated datasets, HCB101 is converging on a profile that is increasingly rare in the CD47 field: a usable safety window combined with reproducible efficacy in combination settings.<\/p>\n

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In the ongoing HCB101-201 combination study, second-line gastric cancer demonstrated an overall objective response rate (ORR) of ~60% (9\/15) across multiple dose cohorts, with higher activity observed at mid-dose levels (5.12 and 8 mg\/kg), where ORR reached ~80% (8\/10). At these dose levels, mean tumor shrinkage was -33.4% and -46.0%, respectively, indicating not only response frequency but also depth of response. First-line HER2-positive gastric cancer achieved an ORR of ~83% (5\/6).<\/p>\n

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These signals\u2014now observed across cohorts and combinations\u2014are beginning to define a consistent pattern of activity rather than isolated responses. In parallel, the HCB101 monotherapy study has escalated to 36 mg\/kg without reaching maximum tolerated dose, supporting a broad therapeutic window and enabling flexible deployment across treatment backbones.<\/p>\n

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Taken together, these data led the SAB to a clear conclusion: HCB101 is emerging as a combination backbone therapy<\/strong>\u2014<\/strong>an innate immune checkpoint designed to integrate across HER2, VEGF, PD-1, and chemotherapy regimens, positioning it as an enabling layer rather than a competing modality.<\/strong><\/p>\n

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\u201cWhat differentiates HCB101 is not just safety or activity in isolation, but the combination of both in a way that allows it to be deployed across multiple backbones,\u201d said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio<\/strong>. \u201cThis is ultimately what determines whether a mechanism becomes clinically usable\u2014and, in this case, potentially foundational to combination therapy.\u201d<\/p>\n

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Based on the totality of data, the SAB reached alignment on prioritizing gastric cancer, particularly in the second-line setting, as the lead registrational path, with further expansion focused on confirming durability, dose optimization, and consistency across combinations.<\/p>\n

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Positioning Within a Combination-Driven IO Landscape<\/strong><\/p>\n

As immuno-oncology shifts beyond single-agent checkpoint blockade, the competitive axis increasingly centers on whether a mechanism can serve as a combination-enabling backbone rather than a standalone therapy. In this environment, value is driven by cross-backbone compatibility, reproducible early efficacy signals, and predictable safety profiles that support continued combination development.<\/p>\n

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Recent large-scale transactions in multi-specific and next-generation checkpoint assets reflect this shift. Within this context, the SAB discussion highlighted that HCB101\u2019s emerging profile, particularly in gastric cancer, aligns with these characteristics of assets designed for combination-based development and potential partnership strategies, further reinforced by its recent Orphan Drug Designation from the U.S. FDA. Cross-backbone compatibility, predictable safety, and early evidence of reproducible efficacy are increasingly defining the center of gravity for deal-making in the sector.<\/p>\n

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HCB301: Extending the Architecture Beyond Single-Mechanism Checkpoints<\/strong><\/p>\n

The SAB also reviewed early clinical data from HCB301, a tri-specific molecule designed to coordinate CD47, PD-L1, and TGFb within a single therapeutic architecture.<\/p>\n

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Early signals of activity were observed, with a disease control rate (DCR) of ~35.7% across dose levels, supporting the biological premise of integrating innate immune activation, adaptive checkpoint modulation, and tumor microenvironment remodeling within one molecule.<\/p>\n

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The discussion reflected a broader shift in the field: as multi-mechanism architectures become increasingly central to immuno-oncology, the key question is no longer feasibility, but clinical usability. In that context, the early safety profile of HCB301\u2014characterized by signals that appear interpretable, reversible, and clinically manageable\u2014was viewed as an important step toward defining how such complex molecules can be developed.<\/p>\n

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The SAB aligned that continued development should focus on establishing predictability and operational control, enabling a path forward for dose optimization and further clinical expansion.<\/p>\n

\u00a0<\/strong><\/p>\n

Beyond Oncology: Expanding the CD47 Platform Across Disease Biology<\/strong><\/p>\n

While HCB101 defines the company\u2019s near-term clinical focus, the SAB also reviewed continued expansion of HanchorBio\u2019s platform beyond oncology.<\/p>\n

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Recent efforts have extended CD47-based and multispecific approaches into autoimmune disease, vascular biology (including atherosclerosis), and central nervous system indications such as glioblastoma, where delivery and immune modulation present distinct challenges. These programs reflect a consistent strategy: leveraging innate immune modulation as a cross-disease mechanism, rather than a cancer-specific approach.<\/p>\n

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Since October 2025, the company has expanded to more than 16 active programs, integrating AI-enabled tools to support target selection, molecular design, and development planning.<\/p>\n

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From Platform to Product<\/strong><\/p>\n

The SAB discussion made clear that HanchorBio is entering a new phase\u2014from platform expansion to clinical prioritization and execution.<\/p>\n

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With gastric cancer now defined as the lead indication for HCB101, and a structured development framework established for HCB301, the company\u2019s focus shifts to confirming durability, scaling combination strategies, advancing into late-stage development, and pursuing potential global partnerships.<\/p>\n

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

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\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","protected":false},"excerpt":{"rendered":"

HanchorBio reported outcomes from its recent Scientific Advisory Board (SAB) meeting, highlighting a shift from platform validation to asset-level positioning and registrational strategy.<\/p>\n","protected":false},"featured_media":0,"template":"","news-category":[34],"class_list":["post-2356","news","type-news","status-publish","hentry","news-category-development-progress"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news\/2356","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:attachment":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/media?parent=2356"}],"wp:term":[{"taxonomy":"news-category","embeddable":true,"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news-category?post=2356"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}