{"id":42051,"date":"2025-12-11T13:00:00","date_gmt":"2025-12-11T13:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4843397_HK43397_0"},"modified":"2025-12-11T13:00:00","modified_gmt":"2025-12-11T13:00:00","slug":"hanchorbio-announces-oral-presentation-of-hcb101-at-the-esmo-immuno-oncology-congress-2025","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=42051","title":{"rendered":"HanchorBio Announces Oral Presentation of HCB101 at the ESMO Immuno-Oncology Congress 2025"},"content":{"rendered":"<div id=\"dvContent\" readability=\"150.44120065789\">\n<p class=\"prntac\"><i>International debut underscores emerging role for macrophage checkpoint therapy in gastric cancer, triple-negative breast cancer, and other hard-to-treat solid tumors<\/i><\/p>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">TAIPEI<\/span>, <span class=\"xn-location\">SHANGHAI<\/span>, AND <span class=\"xn-location\">SAN FRANCISCO<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Dec. 11, 2025<\/span><\/span> \/PRNewswire\/ &#8212; HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced that new clinical data from its flagship macrophage-checkpoint program, HCB101, has been selected for a mini oral presentation at the ESMO Immuno-Oncology Congress 2025 in <span class=\"xn-location\">London, United Kingdom<\/span>. Only 26 abstracts were chosen for mini-oral presentation this year, marking a major milestone for HanchorBio as it delivers its first-ever oral presentation of clinical data at an international oncology congress, following its prior preclinical oral presentation of HCB101 at CSCO&nbsp;2022.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\" readability=\"7\">\n<p> <a href=\"https:\/\/mma.prnasia.com\/media2\/2842512\/HanchorBio_Announces_Oral_Presentation_of_HCB101_at_ESMO.html\" target=\"_blank\" rel=\"nofollow noopener\"> <img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2842512\/HanchorBio_Announces_Oral_Presentation_of_HCB101_at_ESMO.jpg?p=medium600\" title=\"HanchorBio Announces Oral Presentation of HCB101 at the ESMO Immuno-Oncology Congress 2025\" alt=\"HanchorBio Announces Oral Presentation of HCB101 at the ESMO Immuno-Oncology Congress 2025\"> <\/a> <br \/><span>HanchorBio Announces Oral Presentation of HCB101 at the ESMO Immuno-Oncology Congress 2025<\/span><\/p>\n<\/p><\/div>\n<p>The ESMO Immuno-Oncology Congress is <span class=\"xn-location\">Europe&#8217;s<\/span> premier meeting dedicated exclusively to immuno-oncology science, distinct from the broader ESMO Annual Congress. While the annual ESMO meeting spans all oncology disciplines, ESMO-IO focuses on immune mechanisms, translational innovation, and next-generation therapeutic strategies across innate and adaptive immunity.<\/p>\n<p><b>Presentation Details:<\/b><\/p>\n<p><b>Abstract ID:<\/b> 242MO<br \/><b>Title:<\/b> <i>HCB101, a Differentiated SIRP\u03b1 Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity Across Solid Tumors and Lymphoma<br \/><\/i><b>First Author:<\/b> Dr. <span class=\"xn-person\">Fangling Ning<\/span>, Affiliated Hospital of Binzhou Medical University<br \/><b>Date \/ Time:<\/b> <span class=\"xn-chron\">11 December 2025<\/span> \/ 11:45 \u2013 <span class=\"xn-chron\">12:45 GMT<\/span><br \/><b>Location:<\/b> Whittle Room, Queen Elizabeth II Centre, <span class=\"xn-location\">London<\/span><br \/><b>Presenter:<\/b> <span class=\"xn-person\">Alvin Luk<\/span>, PhD, MBA, CCRA &#8211; President &amp; CMO (Group) and CEO (<span class=\"xn-location\">U.S.A.<\/span>), <i>TIME100 <\/i>Health 2025 Honoree<\/p>\n<p>&#8220;For nearly a decade, CD47 therapies were held back not by flawed biology but by flawed molecules, which struggled to balance safety and efficacy at the same time, especially in immunologically cold tumors,&#8221; said <b><span class=\"xn-person\">Scott Liu<\/span>, PhD, Founder, Chairman, and CEO of HanchorBio<\/b>. &#8220;HCB101 was engineered from the ground up to solve that problem. Using AI-guided structural modeling, we identified three core mutations that reshape&nbsp;SIRP\u03b1&#8217;s interaction with CD47, allowing us to combine the strengths of first- and second-generation approaches into a single, differentiated molecule. Being selected as one of only 26 mini-oral presentations at ESMO Immuno-Oncology reinforces the field&#8217;s recognition of this effort and redefines the CD47 therapies. With its clean safety profile, strong target engagement, and early activity in cold tumors, HCB101 is emerging as a true macrophage-checkpoint backbone \u2013 much like the transformative PD-1\/PD-L1 therapies that were based on T-cell checkpoint inhibition.&#8221;<\/p>\n<p><b><u>Key Findings Highlighted in the Mini-Oral<\/u><\/b><\/p>\n<p><b>Monotherapy (HCB101-101; NCT05892718)<\/b><\/p>\n<ul type=\"disc\">\n<li>Clean, cytopenia-sparing safety across 12 cohorts up to 36 mg\/kg QW<\/li>\n<li>No bleeding events or immune-related toxicities, with the majority of treatment-related adverse events being Grade 1-2<\/li>\n<li>Linear PK (T<sub>1\/2 <\/sub>~3 days) with receptor occupancy (RO) &gt;99% at \u22658 mg\/kg<\/li>\n<li>Durable antitumor activity, including confirmed PRs in:\n<ul type=\"disc\">\n<li>HNSCC -Head and neck squamous cell carcinoma (~42% tumor regression, \u226532 weeks)<\/li>\n<li>MZL &#8211; Marginal zone lymphoma (~89% tumor regression, \u226516 weeks)<\/li>\n<\/ul>\n<\/li>\n<li>Stable disease \u22654-9 months across colorectal cancer (CRC), ovarian cancer, non-small cell lung cancer (NSCLC), and sarcoma<\/li>\n<li><b>Combination Therapy (HCB101-201; NCT06771622)<\/b><\/li>\n<li>Well-tolerated across gastric cancer (GC), triple-negative breast cancer (TNBC), CRC, and HNSCC<\/li>\n<li>No new safety signals across all evaluated combinations<\/li>\n<li>Cytopenias fully attributable to chemotherapy, not HCB101<\/li>\n<li>2L GC:\n<ul type=\"disc\">\n<li>58.3%&nbsp;ORR (7\/12) for all cohorts evaluated, 77.8% ORR (7\/9) for mid-dose cohorts, and 100% DCR<\/li>\n<li>Tumor shrinkage up to -78.2%<\/li>\n<\/ul>\n<\/li>\n<li>1L HER2+ GC: 33% ORR (1\/3)<\/li>\n<li>1L TNBC: 50% ORR (3\/6) and 100% DCR<\/li>\n<\/ul>\n<p><b><span class=\"xn-person\">Alvin Luk<\/span>, PhD, MBA, CCRA, President &amp; Chief Medical Officer (Group) and Chief Executive Officer (<span class=\"xn-location\">U.S.A.<\/span>) of HanchorBio<\/b>, added, &#8220;The early efficacy signals from HCB101 are unusually compelling for this stage of development. In second-line GC, where standard therapy achieves an ORR of about 27%, HCB101 combinations exceed 78% ORR, achieve 100% disease control, and result in tumor reduction approaching -78%. These results are not incremental; they meaningfully exceed expectations and reflect robust macrophage checkpoint engagement. With clean safety and sustained receptor occupancy, the data give us confidence to anchor development in second-line disease and expand into first-line and perioperative settings where depth and durability of response matter most.&#8221;<\/p>\n<p><b>About HCB101: A Next-Generation SIRP\u03b1 Fc-Fusion Protein<\/b><\/p>\n<p>HCB101 is a 3.5<sup>th<\/sup>-generation engineered SIRP\u03b1-Fc fusion protein with an intact IgG4 Fc backbone, developed using HanchorBio&#8217;s FBDB\u2122 platform to selectively target&nbsp;tumor&nbsp;CD47 while minimizing&nbsp;binding to&nbsp;red blood cells. This design avoids the anemia and thrombocytopenia that limited early anti-CD47 programs, while preserving potent macrophage activation and downstream T-cell engagement. Key differentiators include:<\/p>\n<ul type=\"disc\">\n<li>Cytopenia-sparing safety up to 30-36 mg\/kg<\/li>\n<li>Receptor occupancy (RO) &gt;99% at clinically active exposures<\/li>\n<li>Strong macrophage and downstream T-cell activation<\/li>\n<li>Broad antitumor activity across &gt;80 PDX\/CDX models and multiple clinical tumor types<\/li>\n<li>Robust early combination efficacy in tumors that historically respond poorly to immunotherapy<\/li>\n<\/ul>\n<p>Unlike earlier approaches, HCB101&#8217;s safety, target selectivity, and RO profile support its use as a macrophage-checkpoint backbone \u2013 analogous to how PD-1\/PD-L1 inhibitors function as foundational T-cell backbones in oncology. HCB101 is designed for broad combinability across established and emerging treatment modalities, including:<\/p>\n<ul type=\"disc\">\n<li>Chemotherapy<\/li>\n<li>Antibody-drug conjugates (ADCs)<\/li>\n<li>Anti-PD-1\/anti-PD-L1 checkpoint inhibitors<\/li>\n<li>Anti-VEGF inhibitors<\/li>\n<li>Anti-EGFR therapies<\/li>\n<li>Anti-HER2 regimens<\/li>\n<\/ul>\n<p>This versatility positions HCB101 as a modular, next-generational immuno-oncology component capable of enhancing the efficacy of multiple therapeutic backbones across solid tumors and hematologic malignancies.<\/p>\n<p><b>About HanchorBio<\/b><\/p>\n<p>Based in <span class=\"xn-location\">Taipei<\/span>, <span class=\"xn-location\">Shanghai<\/span>, and the <span class=\"xn-location\">San Francisco Bay Area<\/span>, HanchorBio (TPEx: 7827) is a global biotechnology company specializing in immuno-oncology. It is led by an experienced team of pharmaceutical industry veterans with a proven track record in biologics discovery and international development, aiming to rewrite the landscape of cancer therapies. Committed to reactivating the immune system to fight diseases, the proprietary Fc-based designer biologics (FBDB\u2122) platform enables the development of unique biologics with diverse multi-targeting modalities, unleashing both innate and adaptive immunity to overcome the current challenges of anti-PD1\/L1 therapies. The FBDB\u2122 platform has successfully delivered proof-of-concept data in several <i>in vivo<\/i> tumor animal models. By advancing breakthroughs in multi-functional, innovative molecular configurations in R&amp;D and improving CMC manufacturing processes, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: <a href=\"https:\/\/www.hanchorbio.com\/\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/www.hanchorbio.com\/<\/a><\/p>\n<\/p><\/div>\n<p>Source: HanchorBio Inc.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>International debut underscores emerging role for macrophage checkpoint therapy in gastric cancer, triple-negative breast cancer, and other hard-to-treat solid tumors TAIPEI, SHANGHAI, AND SAN FRANCISCO, Dec. 11, 2025 \/PRNewswire\/ &#8212; HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced that new clinical data from its [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-42051","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>HanchorBio Announces Oral Presentation of HCB101 at the ESMO Immuno-Oncology Congress 2025 - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=42051\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"HanchorBio Announces Oral Presentation of HCB101 at the ESMO Immuno-Oncology Congress 2025 - My Blog\" \/>\n<meta property=\"og:description\" content=\"International debut underscores emerging role for macrophage checkpoint therapy in gastric cancer, triple-negative breast cancer, and other hard-to-treat solid tumors TAIPEI, SHANGHAI, AND SAN FRANCISCO, Dec. 11, 2025 \/PRNewswire\/ &#8212; HanchorBio Inc. 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