{"id":1719,"date":"2025-06-03T12:00:24","date_gmt":"2025-06-03T04:00:24","guid":{"rendered":"https:\/\/www.hanchorbio.com\/?post_type=news&#038;p=1719"},"modified":"2025-11-10T17:28:01","modified_gmt":"2025-11-10T09:28:01","slug":"hanchorbio-presents-promising-phase-1-hcb101-data-at-asco-2025-confirmed-partial-response-observed-in-solid-tumor-and-lymphoma-patients","status":"publish","type":"news","link":"https:\/\/www.hanchorbio.com\/en\/news\/hanchorbio-presents-promising-phase-1-hcb101-data-at-asco-2025-confirmed-partial-response-observed-in-solid-tumor-and-lymphoma-patients\/","title":{"rendered":"HanchorBio Presents Promising Phase 1 HCB101 Data at ASCO 2025 \u2013 Confirmed Partial Response Observed in Solid Tumor and Lymphoma Patients"},"content":{"rendered":"<div>\u3010TAIPEI, SHANGHAI, and SAN FRANCISCO, June 02, 2025\u3011\u2013 HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, today presented interim data from its lead immunotherapy product, HCB101, following its poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31 \u2013 June 4 in Chicago, Illinois. The data, featured in a poster session, demonstrated favorable safety, high CD47 receptor occupancy, and early clinical signs of anti-tumor activity, including confirmed partial response (PR) in patients with head and neck cancer (HNSCC) and marginal zone lymphoma.<\/div>\n<div><\/div>\n<div>The ongoing Phase 1 dose-escalation trial (NCT05892718) is evaluating HCB101, a differentiated (engineered) SIRP\u03b1-Fc fusion protein targeting CD47-SIRP\u03b1 signaling pathway, in patients with advanced solid tumors or relapsed\/refractory (R\/R) non-Hodgkin lymphomas (NHLs). As of April 23, 2025, the study had enrolled 36 patients from the United States, Taiwan, and mainland China.<\/div>\n<div><\/div>\n<div>Key findings include:<\/div>\n<div>oFavorable safety and tolerability across escalating doses<\/div>\n<div>oHigh-level CD47 receptor occupancy in peripheral immune cells<\/div>\n<div>oPartial responses were observed in patients with head and neck cancer (HNSCC) and NHL<\/div>\n<div><\/div>\n<div>Importantly, early signs of anti-tumor activity were observed.\u00a0 Six patients reported Stable Disease (SD) as the best response, one of which with ovarian cancer (1.28 mg\/kg) exceeded 24 weeks of disease control. Two patients reported Partial Response (PR), one of which with HNSCC (5.12 mg\/kg) initially exhibited a 27% reduction in the sum of diameters (SOD) for target lesions at week 8, which subsequently deepened to a confirmed PR with a 42% SOD reduction at week 16. Another confirmed PR was observed via PET imaging at week 8 in a patient with marginal zone lymphoma (8 mg\/kg).<\/div>\n<div><\/div>\n<div>\u201cWe are honored to share the HCB101 Phase 1a data following our presentation at ASCO 2025,\u201d said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. \u201cHCB101 is the first engineered SIRP\u03b1-Fc fusion protein to show favorable safety, robust receptor occupancy, and signs of anti-solid-tumor efficacy in patients with advanced cancers \u2013 all as a monotherapy in a Phase 1a clinical setting. Unlike earlier CD47-targeting agents, HCB101 was specifically designed to overcome limitations related to on-target toxicities and dependency on combination therapies while exhibiting a drastically enhanced (~1000-fold greater than wild-type SIRP\u03b1-Fc fusion proteins) ability to block the \u201cdo not eat me\u201d signal generated by CD47. The clinical responses observed in patients with advanced solid tumors and R\/R NHL further validate HCB101\u2019s potential as a best-in-class macrophage checkpoint immunotherapy. This milestone reinforces our conviction that HCB101 can serve as a foundational asset for next-generation combinations in both oncology and autoimmune diseases.\u201d<\/div>\n<div><\/div>\n<div>The confirmed partial response in the NHL patient and the HNSCC patient marks a significant milestone for the HCB101 program, highlighting its therapeutic potential in both solid tumors and hematologic malignancies. Radiographic and pharmacodynamic evidence of response was presented during the poster session at ASCO on June 2, 2025.<\/div>\n<div><\/div>\n<div>Developed using HanchorBio\u2019s proprietary FBDB\u2122 platform, HCB101 is engineered to block the SIRP\u03b1-CD47 \u2018don\u2019t-eat-me\u2019 signal and promote macrophage-mediated tumor phagocytosis without inducing red blood cell-related toxicity\u2014a major hurdle for previous CD47 inhibitors. Repeat-dose preclinical studies confirmed no meaningful hematologic toxicity, which is consistent with the manageable safety profile observed to date in the clinic.<\/div>\n<div><\/div>\n<div>\u201cWe are highly encouraged by the preliminary efficacy signals, especially the partial response in a marginal zone lymphoma patient and a HNSCC patient, and multiple long-lasting stable diseases in patients with solid tumors such as head and neck, colon, and ovarian cancer,\u201d said Lucy Yan, M.D., Ph.D., Chief Medical Officer of HanchorBio. \u201cThese results suggest that HCB101\u2019s mechanism of action can translate into meaningful clinical benefit while avoiding the hematologic liabilities that have hindered other CD47 agents.\u201d<\/div>\n<div><\/div>\n<div>Building on these promising findings, HanchorBio is actively advancing expansion cohorts, combination strategies, and global partnership discussions to accelerate the development of HCB101 and its FBDB\u2122 platform.<\/div>\n<div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, today presented interim data from its lead immunotherapy product, HCB101, following its poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31 \u2013 June 4 in Chicago, Illinois. The data, featured in a poster session, demonstrated favorable safety, high CD47 receptor occupancy, and early clinical signs of anti-tumor activity, including confirmed partial response (PR) in patients with head and neck cancer (HNSCC) and marginal zone lymphoma.<\/p>\n","protected":false},"featured_media":946,"template":"","news-category":[],"class_list":["post-1719","news","type-news","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news\/1719","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\/946"}],"wp:attachment":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/media?parent=1719"}],"wp:term":[{"taxonomy":"news-category","embeddable":true,"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news-category?post=1719"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}