{"id":2324,"date":"2026-03-16T19:00:40","date_gmt":"2026-03-16T11:00:40","guid":{"rendered":"https:\/\/www.hanchorbio.com\/?post_type=news&p=2324"},"modified":"2026-03-16T17:32:51","modified_gmt":"2026-03-16T09:32:51","slug":"hanchorbio-presents-first-public-clinical-data-for-hcb301-a-tri-specific-innate-checkpoint-molecule-at-esmo-tat-2026","status":"publish","type":"news","link":"https:\/\/www.hanchorbio.com\/en\/news\/hanchorbio-presents-first-public-clinical-data-for-hcb301-a-tri-specific-innate-checkpoint-molecule-at-esmo-tat-2026\/","title":{"rendered":"HanchorBio Presents First Public Clinical Data for HCB301, a Tri-Specific Innate Checkpoint Molecule, at ESMO-TAT 2026"},"content":{"rendered":"

HanchorBio Presents First Public Clinical Data for HCB301, a Tri-Specific Innate Checkpoint Molecule, at ESMO-TAT 2026<\/strong><\/h2>\n

Initial Phase 1 dose-escalation results demonstrate manageable safety and support continued clinical evaluation of next-generation multi-checkpoint engineering.<\/em><\/h3>\n

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

[Taipei, Shanghai, San Francisco<\/strong> | March 16, 2026<\/strong>] \u2013 HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the presentation of first-in-human clinical data for HCB301 at the ESMO Targeted Anticancer Therapies (TAT) Congress 2026 in Paris, France.<\/p>\n

 <\/p>\n

HCB301-101 (NCT06487624) is an ongoing Phase 1 first-in-human study evaluating HCB301, a tri-specific Fc-fusion protein designed to simultaneously target CD47, PD-L1, and TGF-\u03b2 pathways to coordinate innate, adaptive, and stromal immune modulation. The data were presented in an oral session by the principal investigator, Dr. Ji Zhu, of the Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital).<\/p>\n

\"\"<\/p>\n

Presentation Details:<\/strong><\/p>\n

Presentation ID:<\/strong>\u00a0 600<\/p>\n

Title:<\/strong> First-in-Human<\/em> Phase 1 Evaluation of HCB301, a Tri-specific SIRP\u03b1-PD-1-TGF\u03b2 Fusion Protein: Safety, Pharmacokinetics, and Multisystem Immune Activation <\/em><\/p>\n

Session Name \/ Location:<\/strong> Proffered Paper session \/ Auditorium Bordeaux, Palais des Congr\u00e8s<\/p>\n

Date \/ Time:<\/strong> 16 March 2026 \/ 16:00 \u2013 17:30 CET<\/p>\n

 <\/p>\n

Oral Presentation: HCB301-101 Phase 1 Dose Escalation <\/strong><\/p>\n

As of the February 2026 data cutoff:<\/p>\n

    \n
  • 19 patients enrolled across three dose levels (0.3, 0.6, and 1.2 mg\/kg)<\/li>\n
  • Step-up dosing implemented to mitigate infusion-related risk<\/li>\n
  • Heavily pretreated population (median 4 prior systemic therapies)<\/li>\n
  • Predominantly Grade 1\u20132 treatment-related adverse events<\/li>\n
  • Predictable, on-mechanism cytopenias without a cumulative anemia signal<\/li>\n
  • No unexpected additive hematologic toxicity despite tri-specific design<\/li>\n<\/ul>\n

    Preliminary Clinical Activity:<\/strong><\/p>\n

      \n
    • 36% disease stabilization (n=14 evaluable) at 0.3\u20131.2 mg\/kg<\/li>\n
    • Durable stable disease observed across multiple tumor types<\/li>\n
    • Activity observed below projected full target exposure<\/li>\n<\/ul>\n

      These findings support continued dose escalation to further characterize pharmacokinetics, pharmacodynamics, and the exposure-response relationship as the study advances toward defining the recommended Phase 2 dose (RP2D).<\/p>\n

       <\/p>\n

      \u201cHCB301 is designed to address multi-compartment immune resistance by coordinating SIRP\u03b1, PD-L1, and TGF-\u03b2 modulation within a single molecule,\u201d said Ji Zhu, MD, PhD<\/strong>., Principal Investigator of the HCB301-101 study. \u201cAt the early dose levels evaluated to date, we have observed a manageable safety profile with predominantly low-grade cytopenias consistent with the mechanism of action. Importantly, disease stabilization has been observed in a heavily pretreated population with limited therapeutic options, even at exposure levels below projected full target engagement. These early data support continued dose escalation to define the therapeutic window of this tri-specific approach.\u201d<\/p>\n

       <\/p>\n

      HCB301 is a tri-specific Fc-fusion protein engineered using HanchorBio\u2019s FBDB\u2122 platform to simultaneously modulate SIRP\u03b1, PD-L1, and TGF-\u03b2 pathways within the tumor microenvironment. By coordinating innate immune activation, adaptive checkpoint inhibition, and stromal modulation in a single molecule, HCB301 is designed to address multi-compartment immune resistance while maintaining structural control over hematologic safety parameters.<\/p>\n

       <\/p>\n

      \u201cHCB301 represents the first clinical validation of our next-generation multi-functional checkpoint architecture,\u201d said Scott Liu, PhD, Founder and Chairman of HanchorBio<\/strong>. \u201cBuilding on the structural calibration established with HCB101, we selected SIRP\u03b1 to activate innate phagocytosis, anti-PD-L1 to restore adaptive T-cell function, and TGF-\u03b2 modulation to address stromal-mediated immune exclusion. The objective was not to increase molecular complexity, but to engineer coordinated modulation across dominant immune-suppression pathways while preserving exposure discipline and hematologic control. These initial clinical findings demonstrate that triple-axis engagement can be advanced with a manageable safety profile, reinforcing the scalability of our FBDB\u2122 platform.\u201d<\/p>\n

       <\/p>\n

      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, Inc. announced the presentation of first-in-human clinical data for HCB301 at the ESMO Targeted Anticancer Therapies (TAT) Congress 2026 in Paris, France.<\/p>\n","protected":false},"featured_media":2323,"template":"","news-category":[34,28],"class_list":["post-2324","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\/2324","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\/2323"}],"wp:attachment":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/media?parent=2324"}],"wp:term":[{"taxonomy":"news-category","embeddable":true,"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news-category?post=2324"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}