{"id":1712,"date":"2025-03-24T12:00:41","date_gmt":"2025-03-24T04:00:41","guid":{"rendered":"https:\/\/www.hanchorbio.com\/?post_type=news&p=1712"},"modified":"2025-11-10T16:41:18","modified_gmt":"2025-11-10T08:41:18","slug":"1712","status":"publish","type":"news","link":"https:\/\/www.hanchorbio.com\/en\/news\/1712\/","title":{"rendered":"HanchorBio Announces Taiwan TFDA Approval for HCB101 Combination Therapy in Advanced Colorectal Cancer"},"content":{"rendered":"
HanchorBio Inc., a global biotechnology company developing innovative immuno-biomedicines to address significant unmet medical needs in oncology, today announced that the Taiwan Food and Drug Administration (TFDA) has approved an investigator-initiated trial (IIT) evaluating HCB101 in combination with cetuximab or bevacizumab and FOLFOX or FOLFIRI for advanced or metastatic colorectal cancer (CRC). The study will take place at Linkou Chang Gung Memorial Hospital under the leadership of Dr. Hung-Chih Hsu. This TFDA approval marks a significant step in expanding and advancing the clinical development of HCB101 through novel combinations with standard-of-care (SOC) therapies to meet unmet medical needs in the immunotherapy of solid tumors, including CRC.<\/span><\/div>\n
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\u201cColorectal cancer remains a leading cause of cancer-related deaths. Despite advancements in targeted therapies and chemotherapy regimens, many patients develop resistance and experience disease progression,\u201d said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. \u201cThe investigator-initiated trial will provide critical insights into the potential of HCB101 to enhance immune-mediated tumor clearance when combined with SOC therapies. With HCB101\u2019s differentiated CD47-SIRP\u03b1 pathway blockade, we aim to determine whether these combination therapies can improve response rates and potentially reduce the toxicity associated with current treatment options for patients with advanced CRC.\u201d<\/span><\/div>\n
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About the Investigator-Initiated Trial in Advanced or Metastatic Colorectal Cancer<\/span><\/u><\/b><\/div>\n
The open-label, dose-escalation, and dose-expansion trial (HCB101-IIT-CRC-202401) is designed to evaluate the safety, tolerability, and preliminary efficacy of HCB101 in combination with cetuximab or bevacizumab and chemotherapy regimens (FOLFOX or FOLFIRI) in patients with RAS\/BRAF wild-type advanced or metastatic colorectal cancer who have progressed following prior systemic therapy.<\/span><\/div>\n
\u2022Trial Sponsor: Linkou Chang Gung Memorial Hospital<\/span><\/div>\n
\u2022Principal Investigator: Dr. Hung-Chih Hsu<\/span><\/div>\n
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HCB101 Combination Rationale<\/span><\/u><\/b><\/div>\n
HCB101 is an engineered SIRP\u03b1 fusion protein developed through AI-assisted structural modeling and large-scale screening of a phage library containing 108 different SIRP\u03b1 variants.\u00a0 It is designed to selectively and effectively block the CD47-SIRP\u03b1 \u201cdon\u2019t eat me\u201d signal, enhancing macrophage phagocytosis and adaptive immune priming while maintaining a desirable safety profile. Preclinical data suggest that CD47 blockade can synergize with antibody-based and chemotherapy regimens to enhance tumor cell elimination while potentially reducing the toxicity burden of specific targeted agents.<\/span><\/div>\n
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  • HCB101 + Cetuximab + Chemotherapy (FOLFOX\/FOLFIRI):\u00a0<\/span><\/u><\/b><\/li>\n
  • Cetuximab, an EGFR-targeting monoclonal antibody, is a cornerstone of CRC therapy. However, cetuximab-induced skin toxicity and infusion-related reactions remain significant clinical challenges, particularly at higher doses. HCB101 is expected to enhance cetuximab-induced antibody-dependent cellular phagocytosis (ADCP), potentially allowing for dose modulation of cetuximab while maintaining therapeutic efficacy.<\/span><\/li>\n
  • Additionally, CD47 blockade may improve antigen presentation and T-cell activation, leading to an enhanced adaptive immune response. This could further potentiate cetuximab\u2019s anti-tumor effects in RAS\/BRAF wild-type tumors while reducing the overall treatment-related adverse events.<\/span><\/span><\/li>\n
  • \u00a0<\/span><\/li>\n
  • HCB101 + Bevacizumab + Chemotherapy (FOLFOX\/FOLFIRI):\u00a0<\/span><\/u><\/b><\/li>\n
  • Bevacizumab, a VEGF inhibitor, is a key component of metastatic CRC treatment. VEGF blockade can increase tumor hypoxia and upregulate CD47 expression by suppressing tumor angiogenesis, creating a more immunosuppressive tumor microenvironment. HCB101 is designed to counteract this immune escape mechanism by enhancing macrophage activity and antibody-dependent cellular phagocytosis, thereby amplifying bevacizumab\u2019s anti-angiogenic effects.<\/span><\/li>\n
  • Preclinical studies have demonstrated that combining this CD47 blockade with VEGF inhibitors leads to superior tumor growth inhibition, suggesting that HCB101 could potentiate bevacizumab\u2019s efficacy while reducing resistance mechanisms in clinical settings.<\/span><\/li>\n<\/ul>\n<\/div>\n
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    \u201cThis IIT represents an important opportunity to evaluate the role of CD47 blockade in reshaping the immune microenvironment in colorectal cancer,\u201d said Dr. Hung-Chih Hsu, Principal Investigator. \u201cGiven the established efficacy of EGFR and VEGF-targeted therapies in CRC, the addition of HCB101 could provide a much-needed boost in immune response while potentially reducing the side effects of standard therapies, offering new hope for patients with advanced disease.\u201d<\/span><\/div>\n
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    About HCB101: A Differentiated CD47-SIPR\u03b1 Blockade<\/span><\/u><\/b><\/div>\n
    HCB101 is a potential best-in-class Fc-fusion SIRP\u03b1 variant designed to optimize immune activation while minimizing hematologic toxicity. Unlike traditional anti-CD47 monoclonal antibodies, HCB101 demonstrates selective tumor engagement with low red blood cell (RBC) binding, reducing the risk of anemia and thrombocytopenia commonly observed with other CD47-targeting agents.<\/span><\/div>\n
    Key Differentiators of HCB101:<\/span><\/div>\n
    \n
      \n
    • Enhanced safety profile: Reduced RBC depletion compared to traditional CD47-targeting agents.<\/span><\/li>\n
    • Synergistic immune activation: Strongly enhanced ADCP, bridging innate and adaptive immune responses to drive durable anti-tumor immunity.<\/span><\/li>\n
    • Broad tumor applicability: Demonstrated activity in over 75 CDX and PDX preclinical models across multiple solid tumors and hematological malignancies.<\/span><\/li>\n<\/ul>\n<\/div>\n
      \u00a0<\/span><\/div>\n
      HCB101 is currently being evaluated in multiple clinical trials, including:<\/span><\/div>\n
      \n
        \n
      • HCB101-101 (NCT05892718): A Phase 1 open-label, multi-regional, multi-center, dose-finding, first-in-human monotherapy trial of HCB101 in advanced solid tumors or relapsed and refractory non-Hodgkin lymphomas.<\/span><\/li>\n
      • HCB101-201 (NCT06771622): A Phase 1b\/2a open-label, multi-regional, multi-center trial of HCB101 in combination with standard-of-care therapies in advanced solid tumors.<\/span><\/li>\n
      • HCB101-IIT-CRC-202401: An open-label, dose-escalation, and dose-expansion investigator-initiated trial of HCB101 in combination with cetuximab or bevacizumab and chemotherapy regimens in RAS\/BRAF wild-type advanced or metastatic colorectal cancer.<\/span><\/li>\n<\/ul>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

        TAIPEI, SHANGHAI, and SAN FRANCISCO, March 24, 2025 \u2013 HanchorBio Inc., a global biotechnology company developing innovative immuno-biomedicines to address significant unmet medical needs in oncology, today announced that the Taiwan Food and Drug Administration (TFDA) has approved an investigator-initiated trial (IIT) evaluating HCB101 in combination with cetuximab or bevacizumab and FOLFOX or FOLFIRI for advanced or metastatic colorectal cancer (CRC). The study will take place at Linkou Chang Gung Memorial Hospital under the leadership of Dr. Hung-Chih Hsu. This TFDA approval marks a significant step in expanding and advancing the clinical development of HCB101 through novel combinations with standard-of-care (SOC) therapies to meet unmet medical needs in the immunotherapy of solid tumors, including CRC.<\/p>\n","protected":false},"featured_media":966,"template":"","news-category":[],"class_list":["post-1712","news","type-news","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news\/1712","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\/966"}],"wp:attachment":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/media?parent=1712"}],"wp:term":[{"taxonomy":"news-category","embeddable":true,"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news-category?post=1712"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}