{"id":1711,"date":"2024-06-28T12:00:45","date_gmt":"2024-06-28T04:00:45","guid":{"rendered":"https:\/\/www.hanchorbio.com\/?post_type=news&p=1711"},"modified":"2025-11-10T16:38:30","modified_gmt":"2025-11-10T08:38:30","slug":"hanchorbio-announces-us-fda-clearance-of-ind-application-for-hcb301-tri-specific-fusion-protein-to-treat-solid-and-hematological-malignancies-2","status":"publish","type":"news","link":"https:\/\/www.hanchorbio.com\/en\/news\/hanchorbio-announces-us-fda-clearance-of-ind-application-for-hcb301-tri-specific-fusion-protein-to-treat-solid-and-hematological-malignancies-2\/","title":{"rendered":"HANCHORBIO ANNOUNCES US FDA CLEARANCE OF IND APPLICATION FOR HCB301 TRI-SPECIFIC FUSION PROTEIN TO TREAT SOLID AND HEMATOLOGICAL MALIGNANCIES"},"content":{"rendered":"
TAIPEI, SHANGHAI, and SAN FRANCISCO, June 28th, 2024 <\/b>\u2013 HanchorBio Inc., a global clinical-stage biotechnology company focusing on the discovery and development of innovative immuno-biomedicines to treat a wide variety of patients suffering from hard-to-treat solid tumors or hematological malignancies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company\u2019s investigational new drug (IND) application to initiate a multi-regional clinical trial of its independently-developed novel drug candidate, HCB301, for the treatment of patients with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.\u00a0 HCB301 is an engineered tri-specific fusion protein comprised of an anti-PD-L1 (Ig) V domain, a parallel-engineered human SIRP\u03b1 (Ig) V domain fused to an IgG4 Fc protein, and an engineered human transforming growth factor-\uf062 (TGF\uf062) trap at the Fc tail that creates synergies between innate immunity checkpoint, an adapted immunity checkpoint, and an immune suppressive cytokine to triggers the modulation of tumor microenvironment, potentially addressing a novel multi-specific immune-therapy approach to tackling cancer.<\/div>\n
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\u201cThe IND clearance marks another significant milestone as we advance our pipeline of multi-targeting Fc-based designer biologics (FBDB\u2122) immunotherapy in cancers,\u201d said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. \u201cThis is our second IND clearance within 3.5 years since the inception of the company and underscores our focused dedication towards developing safe and effective treatments derived from our FBDB\u2122 platform to re-engage innate and adaptive immunity through multifunctional designs to overcome the inadequacies of anti-PD1\/L1 therapies. HCB301 IND is the first tri-specific fusion protein targeting SIRP\u03b1\/CD47, PD-1\/PD-L1, and TGF\u03b2\/TGF\u03b2 trap pathways simultaneously.\u201d<\/div>\n
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\u201cBased on our in-vitro and in-vivo pre-clinical studies, HCB301 has demonstrated remarkable inhibition of multiple tumor cell lines and murine xenograft tumor models of solid and hematological malignancies, compared with TGF\uf062 trap, anti-PD-L1 agents, anti-CD47 agents, in either multi-specific antibody or in their disparate soluble combinations,\u201d said Jonathan Wang, Ph.D., Senior Director of Research Department of HanchorBio. \u201cUnlike other CD47-blocking agents, HCB301 exhibits lower binding activity in preclinical settings to human red blood cells (RBCs), but similar binding activity to platelets, with no obvious abnormality of RBC or platelet levels being observed in the repeat-dose cynomolgus monkey toxicology studies.\u201d<\/div>\n
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\u201c Given the encouraging outcomes thus far regarding HCB101 (an engineered extracellular domain of SIRP\u03b1 fused to the Fc region of IgG4 as a safer and more potent biologic than the anti-CD47 monoclonal antibodies) in our ongoing Phase 1 trial (NCT05892718), we are optimistic about the potential benefits that may emerge of HCB301 based on the foundation of HCB101,\u201d stated by David Sun, M.D., Ph.D., Senior Vice President of Global Clinical and Medical Affairs of HanchorBio. \u201cOur medical and clinical teams look forward to advancing the clinical development of HCB301 to bring clinically meaningful benefits to patients as early as possible.\u201d<\/div>\n
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About HCB301<\/u><\/b><\/div>\n
Using structure-guided protein design and engineering supplemented with relevant screening technologies, HCB301 is a tri-specific fusion protein: an engineered IgV domain of human SIRP\u03b1 fused to an anti-PD-L1 (Ig) V domain and an engineered human TGFRII. This results in blocking the checkpoint CD47 simultaneously with T-lymphocyte checkpoint PD-L1 blocking while inhibiting the activities of TGF\uf062-mediated immune-suppression functions. HCB301 exhibits good safety profiles in the repeat-dose cynomolgus monkey toxicology studies, as no obvious abnormality of RBC or platelet levels was observed, and a unique differential binding to tumor cells vs. RBC binding and subsequent significant decreases in phagocytosis may potentially reduce patient\u2019s risk of anemia, thrombocytopenia, or any other cytopenia while maintaining potent anti-tumor activities.<\/div>\n
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About Multi-regional Clinical Trial of HCB301 (NCTXXXX)<\/u><\/b><\/div>\n
HCB301-101 is a multiregional, multicenter, open-label, dose-finding, first-in-human (FIH) study of adults with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas in the United States, Australia, and Taiwan. The study evaluates the safety, tolerability, pharmacokinetics, and preliminary clinical efficacy of weekly HCB301 intravenous injections. The HCB301 IND is on track to be reviewed by the Australia Therapeutic Goods Administration (TGA) and the Taiwan FDA.<\/div>\n
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About HanchorBio\u00a0<\/u><\/b><\/div>\n
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio is led by an experienced team of pharmaceutical industry veterans with a proven track record of success in biologics discovery and global development to transcend current cancer therapies. Committed to reactivating the immune system to fight against diseases, the proprietary Fc-based designer biologics (FBDB\u2122) platform enables unique biologics with diverse multi-targeting modalities to unleash both innate and adaptive immunity to overcome the current inadequacies of anti-PD1\/L1 therapies. The FBDB\u2122 platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit HanchorBio or follow us on LinkedIn.<\/div>\n
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HanchorBio Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company\u2019s investigational new drug (IND) application to initiate a multi-regional clinical trial of its independently developed novel drug candidate, HCB301 today.HCB301-101 is a multiregional, multicenter, open-label, dose-finding, first-in-human (FIH) study of adults with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas in the US, Australia, and Taiwan. The study evaluates the safety, tolerability, pharmacokinetics, and preliminary clinical efficacy of weekly HCB301 intravenous injections. The HCB301 IND is on track to be reviewed by the Australia Therapeutic Goods Administration (TGA) and the Taiwan FDA.<\/p>\n","protected":false},"featured_media":975,"template":"","news-category":[],"class_list":["post-1711","news","type-news","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news\/1711","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\/975"}],"wp:attachment":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/media?parent=1711"}],"wp:term":[{"taxonomy":"news-category","embeddable":true,"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news-category?post=1711"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}