{"id":41390,"date":"2025-11-07T14:00:00","date_gmt":"2025-11-07T14:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4817363_HK17363_0"},"modified":"2025-11-07T14:00:00","modified_gmt":"2025-11-07T14:00:00","slug":"hanchorbio-presents-two-late-breaking-abstracts-at-the-society-for-immunotherapy-of-cancer-2025-demonstrating-best-in-class-potential-of-hcb101-in-advanced-cancers","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=41390","title":{"rendered":"HanchorBio Presents Two Late-Breaking Abstracts at the Society for Immunotherapy of Cancer 2025 Demonstrating Best-in-Class Potential of HCB101 in Advanced Cancers"},"content":{"rendered":"<div id=\"dvContent\" readability=\"134.00488460994\">\n<p class=\"prntac\"><i>Late-breaking poster presentations show HCB101&#8217;s favorable safety, strong receptor occupancy, and promising monotherapy and combination activity in tumors historically unresponsive to immunotherapy<\/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\">Nov. 7, 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 the presentation of two late-breaking abstracts on its lead asset, HCB101, at the 40<sup>th <\/sup>Annual Meeting of the Society for Immunotherapy of Cancer (SITC), held <span class=\"xn-chron\">November 5-9, 2025<\/span>, in National Harbor, <span class=\"xn-location\">Maryland<\/span>. Both datasets were accepted for late-breaking poster presentations, highlighting the program&#8217;s potential impact on innate immune checkpoint blockade.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder2760\" readability=\"10\">\n<p><a href=\"https:\/\/mma.prnasia.com\/media2\/2815343\/HCB101_a_Next_Generation_Fc_Engineered_SIRP__CD47_Fusion_Protein_Demonstrates_Favorable_Safety.html\" target=\"_blank\" rel=\"nofollow noopener\"><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2815343\/HCB101_a_Next_Generation_Fc_Engineered_SIRP__CD47_Fusion_Protein_Demonstrates_Favorable_Safety.jpg?p=medium600\" title=\"HCB101, a Next-Generation Fc-Engineered SIRP\u03b1-CD47 Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity in Advanced Cancers\" alt=\"HCB101, a Next-Generation Fc-Engineered SIRP\u03b1-CD47 Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity in Advanced Cancers\"><\/a><br \/><span>HCB101, a Next-Generation Fc-Engineered SIRP\u03b1-CD47 Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity in Advanced Cancers<\/span><\/p>\n<\/p><\/div>\n<p>HCB101&#8217;s progress reflects its distinct engineering compared to earlier CD47-targeting approaches. First-generation CD47 antibodies, such as magrolimab and lemzoparlimab, demonstrated clinical activity but faced significant safety or efficacy challenges, leading to discontinuations or halted collaborations. Second-generation wild-type SIRP\u03b1 fusions, such as maplirpacept (TTI-622), improved safety but did not deliver sufficient efficacy in solid tumors, limiting their adoption. IgG1-based fusions attempted to boost immune activation but triggered excessive Fc\u03b3-mediated toxicity and poor tolerability, restricting their use mainly to hematologic malignancies. Third-generation engineered SIRP\u03b1 fusions with inactivated IgG1 Fc improved safety in combinations but showed limited standalone efficacy.&nbsp;<\/p>\n<p>&#8220;The acceptance of two late-breaking abstracts at SITC for HCB101 monotherapy and combination therapy, along with our earlier preclinical abstract for HCB301, a tri-specific fusion targeting SIRP\u03b1\/CD47, PD-1\/PD-L1, and TGF\u03b2, reinforces the scientific breadth of our platform across innate and adaptive immunity,&#8221; said <b><span class=\"xn-person\">Scott Liu<\/span>, Ph.D., Founder, Chairman, and CEO of HanchorBio. <\/b>&#8220;HCB101 was purposely engineered to overcome the&nbsp;cytopenias seen with first-generation anti-CD47 antibodies while maintaining potent immune activation. In second-line gastric cancer, the combination of HCB101 with standard-of-care therapy achieved a 100% confirmed response rate in the active-dose cohort, far exceeding the 28% ORR benchmark from the RAINBOW trial. These results position HCB101 not just as a safer SIRP\u03b1-CD47 backbone, but as a next-generation macrophage checkpoint immunotherapy with best-in-class potential.&#8221;<\/p>\n<p>Late-Breaking Abstract Highlights (Data as of <span class=\"xn-chron\">August 2025<\/span>)<\/p>\n<p>1. HCB101-101&nbsp;Monotherapy Study (NCT05892718)<\/p>\n<p>Title: <b><i>HCB101, a Next-Generation Fc-Engineered SIRP\u03b1-CD47 Fusion Protein, <\/i><\/b><b><i>Demonstrates Favorable Safety and Early&nbsp;Antitumor Activity in Advanced Cancers<\/i><\/b><\/p>\n<ul type=\"disc\">\n<li>In the ongoing Phase 1a dose-escalation, no dose-limiting toxicities (DLTs) have been observed at doses up to 24 mg\/kg.<\/li>\n<li>CD47 receptor occupancy \u226599% achieved at doses \u22655 mg\/kg, with dose-proportional pharmacokinetics.<\/li>\n<li>Confirmed partial responses seen in head and neck squamous cell carcinoma (HNSCC) and marginal zone lymphoma (MZL).<\/li>\n<li>Several patients achieved stable disease, with progression-free survival up to 32 weeks.<\/li>\n<\/ul>\n<p>2. HCB101-201 Combination Therapy Study (NCT06771622)<\/p>\n<p>Title: <b><i>Phase <span class=\"xn-money\">1b<\/span>\/2a Study of HCB101 Combined with Standard Therapies Demonstrates Manageable Safety and Dose-Dependent Antitumor Activity in Immunologically Cold Advanced Solid Tumors<\/i><\/b><\/p>\n<ul type=\"disc\">\n<li>In second-line gastric cancer (GC):\n<ul type=\"disc\">\n<li>100% confirmed partial response rate (6\/6 evaluable patients) at active doses when combined with ramucirumab and paclitaxel.<\/li>\n<li>Tumor shrinkage up to 78%, surpassing the ~26.5% ORR benchmark from RAINBOW.<\/li>\n<\/ul>\n<\/li>\n<li>In first-line triple-negative breast cancer (TNBC):\n<ul type=\"disc\">\n<li>Confirmed partial response with 73% tumor reduction at the effective dose.<\/li>\n<\/ul>\n<\/li>\n<li>Safety was manageable and consistent with the&nbsp;cytopenia-sparing design, with only minimal hematologic effects observed.<\/li>\n<\/ul>\n<p><b>Dr. <span class=\"xn-person\">Fangling Ning<\/span><\/b>, Investigator from the Affiliated Hospital of Binzhou Medical University, commented, &#8220;What&#8217;s unique about HCB101 is that it avoids the cytopenias that plagued anti-CD47 antibodies by minimizing red blood cell binding, while still engaging CD47 strongly on tumor cells. In our gastric cancer cohort, the responses at active doses are encouraging in a patient population that historically has had limited options. These findings validate HCB101&#8217;s unique design and suggest meaningful potential in immunologically cold tumors.&#8221;<\/p>\n<p><b>About HCB101: A Differentiated CD47-SIRP\u03b1 Blockade<\/b><\/p>\n<p>HCB101 is a 3.5<sup>th<\/sup>-generation, affinity-optimized SIRP\u03b1-Fc fusion protein with an intact IgG4 Fc backbone, developed using HanchorBio&#8217;s proprietary FBDB\u2122 platform. It is engineered for selective CD47 targeting with low red blood cell (RBC) binding, thereby avoiding the anemia and thrombocytopenia commonly associated with earlier anti-CD47 monoclonal antibodies, while preserving strong antibody-dependent cellular phagocytosis (ADCP) and innate-to-adaptive immune bridging. Key differentiators of HCB101:<\/p>\n<ul type=\"disc\">\n<li><b>Enhanced safety: <\/b>Cytopenia-sparing profile, with no DLTs observed up to 30 mg\/kg and receptor occupancy &gt;90% at \u22651.28 mg\/kg, supporting a broad therapeutic window.<\/li>\n<li><b>Robust immune activation:<\/b> Engineered to enhance ADCP and bridge innate-to-adaptive immunity, with evidence of durable immune-mediated tumor control in monotherapy.<\/li>\n<li><b>Broad tumor applicability:<\/b> Demonstrated activity across &gt;80 PDX and CDX preclinical models, with early clinical signals in gastric cancer, TNBC, HNSCC, non-Hodgkin lymphoma, and ovarian cancer.<\/li>\n<li><b>Clinical translation:<\/b> Shows durable disease control as monotherapy and a 100% confirmed partial response rate (6\/6) in 2L gastric cancer when combined with ramucirumab and paclitaxel, with additional confirmed responses in 1L TNBC and 2L HNSCC, substantially exceeding historical benchmarks.<\/li>\n<\/ul>\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 San Francisco Bay Area,&nbsp;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>Late-breaking poster presentations show HCB101&#8217;s favorable safety, strong receptor occupancy, and promising monotherapy and combination activity in tumors historically unresponsive to immunotherapy TAIPEI, SHANGHAI, and SAN FRANCISCO, Nov. 7, 2025 \/PRNewswire\/ &#8212; HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the presentation of two [&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-41390","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 Presents Two Late-Breaking Abstracts at the Society for Immunotherapy of Cancer 2025 Demonstrating Best-in-Class Potential of HCB101 in Advanced Cancers - 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=41390\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"HanchorBio Presents Two Late-Breaking Abstracts at the Society for Immunotherapy of Cancer 2025 Demonstrating Best-in-Class Potential of HCB101 in Advanced Cancers - My Blog\" \/>\n<meta property=\"og:description\" content=\"Late-breaking poster presentations show HCB101&#8217;s favorable safety, strong receptor occupancy, and promising monotherapy and combination activity in tumors historically unresponsive to immunotherapy TAIPEI, SHANGHAI, and SAN FRANCISCO, Nov. 7, 2025 \/PRNewswire\/ &#8212; HanchorBio Inc. 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