{"id":2624,"date":"2026-10-14T21:20:23","date_gmt":"2026-10-14T13:20:23","guid":{"rendered":"https:\/\/www.hanchorbio.com\/?post_type=news&#038;p=2624"},"modified":"2026-10-14T21:25:24","modified_gmt":"2026-10-14T13:25:24","slug":"hanchorbio-expands-hcb101-colorectal-cancer-program-in-taiwan-as-early-2l-crc-data-show-50-orr-and-100-dcr","status":"publish","type":"news","link":"https:\/\/www.hanchorbio.com\/en\/news\/hanchorbio-expands-hcb101-colorectal-cancer-program-in-taiwan-as-early-2l-crc-data-show-50-orr-and-100-dcr\/","title":{"rendered":"HanchorBio Expands HCB101 Colorectal Cancer Program in Taiwan as Early 2L CRC Data Show 50% ORR and 100% DCR"},"content":{"rendered":"<h2><strong>HanchorBio Expands HCB101 Colorectal Cancer Program in Taiwan as Early 2L CRC Data Show 50% ORR and 100% DCR<\/strong><\/h2>\n<h3><em>First patient dosed in Taiwan expands HCB101\u2019s global CRC development following positive responses across multiple treatment regimens and durable clinical benefit with HCB101 plus bevacizumab and chemotherapy<\/em><\/h3>\n<p>&nbsp;<\/p>\n<p>[<strong>Taipei, Shanghai, San Francisco<\/strong> | <strong>October 1<\/strong><strong>4<\/strong><strong>, 2026<\/strong>] \u2013 HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today announced that the first patient in Taiwan has been dosed in the colorectal cancer (CRC)-specific cohort of its global Phase 1b\/2a HCB101-201 study (NCT06771622), expanding the Company\u2019s global development program in second-line metastatic CRC.<\/p>\n<p>&nbsp;<\/p>\n<p>The Taiwan expansion of the HCB101-201 study is evaluating HCB101, an AI-assisted, structure-guided SIRP\u03b1-IgG4 Fc fusion protein developed using HanchorBio\u2019s proprietary FBDB\u2122 platform, in combination with standard-of-care regimens\u00a0in patients with second-line metastatic CRC.<\/p>\n<p>&nbsp;<\/p>\n<p>The expansion builds on encouraging early activity across HanchorBio\u2019s sponsor-led second-line microsatellite-stable CRC cohorts. Among\u00a012 efficacy-evaluable patients who received HCB101 at 5 or 8 mg\/kg in combination with different standard-of-care regimens, six achieved partial responses and six achieved stable disease, corresponding to a 50% objective response rate (ORR) and 100% disease control rate (DCR) at first assessment.<\/p>\n<p>&nbsp;<\/p>\n<p>\u201cThe emerging CRC data are important because the activity is not confined to a single regimen,\u201d said\u00a0<strong>Scott Liu, Ph.D., Founder, Chairman, and CEO (Group) of HanchorBio<\/strong>. \u201cWe are seeing responses across multiple standard-of-care backbones, while the earlier investigator-initiated data from Taiwan provides complementary evidence of durable disease control. That combination of breadth and durability strengthens our rationale to expand HCB101 development in second-line CRC.\u201d<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Broad Activity Across Multiple Second-Line CRC Backbones<\/strong><\/p>\n<p>Across the current sponsor-led CRC cohorts, partial responses have been observed with:<\/p>\n<ul>\n<li>HCB101 + bevacizumab + chemotherapy<\/li>\n<li>HCB101 + cetuximab + chemotherapy<\/li>\n<li>HCB101 + ramucirumab + FOLFIRI<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>The\u00a0bevacizumab-plus-chemotherapy\u00a0combination therapy provides a particularly relevant bridge between the sponsor-led program and earlier investigator-initiated clinical data from Taiwan. In sponsor-led\u00a0HCB101-201 Cohort 3a, four evaluable patients treated with\u00a0HCB101 8 mg\/kg plus bevacizumab and chemotherapy\u00a0achieved\u00a02 partial responses and 2 stable diseases, corresponding to a\u00a050% ORR and 100% DCR.<\/p>\n<p>&nbsp;<\/p>\n<p>Separately, in a Taiwan investigator-initiated study (NCT07204574), three evaluable CRC patients received lower-dose\u00a0HCB101 2.56 mg\/kg plus bevacizumab and chemotherapy. All three achieved disease control at first assessment, including\u00a0one patient with ongoing clinical benefit beyond 63 weeks\u00a0and another who maintained disease control for\u00a0more than 48 weeks before progression.<\/p>\n<p>&nbsp;<\/p>\n<p>For clinical context, bevacizumab plus chemotherapy has historically produced ORRs of approximately\u00a05%\u201323%\u00a0and median progression-free survival of approximately\u00a05.7\u20137.3 months\u00a0in randomized second-line metastatic CRC studies. Cross-trial comparisons should be interpreted cautiously because of differences in study design, patient characteristics, prior therapy, and other factors.<\/p>\n<p>&nbsp;<\/p>\n<p>\u201cWhat stands out is the consistency of the emerging signal,\u201d said <strong>Alvin Luk, Ph.D., M.B.A., C.C.R.A., President and Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio<\/strong>. \u201cAcross our current sponsor-led CRC cohorts, HCB101 combinations have produced a 50% ORR and 100% disease control, with responses across anti-VEGF-, anti-EGFR-, and chemotherapy-based treatment architectures. With bevacizumab plus chemotherapy specifically, we have now seen objective responses in the sponsor-led study together with prolonged disease control in the earlier investigator-initiated study in Taiwan. These remain small, early datasets and should not be directly compared or pooled, but the consistency of the observations supports continued prospective development.\u201d<\/p>\n<p>&nbsp;<\/p>\n<p><strong>From Early Taiwan Clinical Observations to Global Development<\/strong><\/p>\n<p>Early investigator-initiated clinical observations in Taiwan contributed important observations to the development of HCB101 in colorectal cancer, particularly regarding the potential durability of disease control with HCB101 in combination with bevacizumab and chemotherapy.<\/p>\n<p>&nbsp;<\/p>\n<p>Initiation of HCB101-201 enrollment in Taiwan now extends those early observations into HanchorBio\u2019s global sponsor-led development program, enabling prospective evaluation within a multicenter clinical study.<\/p>\n<p>&nbsp;<\/p>\n<p>HCB101-201 is a global, multicenter, open-label Phase 1b\/2a study evaluating HCB101 in rational combinations across prioritized solid tumors, including\u00a0gastric\/GEJ cancer, colorectal cancer, head and neck squamous cell carcinoma, and triple-negative breast cancer.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>About HCB101<\/strong><\/p>\n<p>HCB101 is an investigational engineered SIRP\u03b1-IgG4 Fc fusion protein developed using HanchorBio\u2019s proprietary FBDB\u2122 platform. HCB101 blocks CD47-SIRP\u03b1 signaling and is designed to enhance macrophage-mediated antitumor immunity. It is being evaluated as monotherapy (NCT05892718) and in combinations (NCT06771622) across solid and hematologic malignancies. HCB101 has received U.S. FDA Orphan Drug Designation for gastric cancer.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p><strong>About HanchorBio<\/strong><\/p>\n<p>HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on inventing and developing next-generation biologics for cancer and immune-mediated diseases using its proprietary FBDB\u2122 platform. HanchorBio\u2019s pipeline includes HCB101, its lead SIRP\u03b1-based innate immune checkpoint program; HCB301, a clinical-stage trispecific immunotherapy targeting SIRP\u03b1, PD-L1, and TGF-\u03b2 biology; HCB303, an IND-cleared trispecific immunotherapy integrating SIRP\u03b1\/CD47, PD-L1\/PD-1, and TIGIT\/PVR biology; and additional programs across oncology and immune-mediated diseases.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Forward-Looking Statements<\/strong><\/p>\n<p>This press release contains forward-looking statements regarding the development of HCB101, the HCB101-201 study and its CRC cohorts, HCB101 combination strategies, and HanchorBio\u2019s pipeline and FBDB\u2122 platform. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially. Early clinical and investigator-initiated data may not predict results from larger or later-stage studies, and historical results are provided for context only; cross-trial comparisons should be interpreted cautiously. There can be no assurance that HCB101 will demonstrate safety or efficacy or obtain regulatory approval. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Investor &amp; Media Contact:<\/strong><\/p>\n<p>Email: <a href=\"mailto:IRPR@hanchorbio.com\">IRPR@hanchorbio.com<\/a><\/p>\n<p><strong>HanchorBio Business Development Contact: <\/strong><\/p>\n<p>Email: <a href=\"mailto:BD@HanchorBio.com\">BD@HanchorBio.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>HanchorBio today announced that the first patient in Taiwan has been dosed in the colorectal cancer (CRC)-specific cohort of its global Phase 1b\/2a HCB101-201 study (NCT06771622), expanding the Company\u2019s global development program in second-line metastatic CRC.<\/p>\n","protected":false},"featured_media":2625,"template":"","news-category":[34,46],"class_list":["post-2624","news","type-news","status-publish","has-post-thumbnail","hentry","news-category-development-progress","news-category-development-progress-2"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news\/2624","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\/2625"}],"wp:attachment":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/media?parent=2624"}],"wp:term":[{"taxonomy":"news-category","embeddable":true,"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news-category?post=2624"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}