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Harbour BioMed Announces U.S. FDA IND Clearance for HBM7004 for the Treatment of Advanced Solid Tumors
Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other disease areas, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for HBM7004, enabling the initiation of a first-in-human (FIH) Phase I clinical trial. The study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor act
About this update from Hbm Holdings Ltd.
[{"type":"text","content":"CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, May 8, 2026 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other disease areas, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for HBM7004, enabling the initiation of a first-in-human (FIH) Phase I clinical trial. The study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM7004 in subjects with advanced solid tumors.","length":654,"tagName":"p"},{"type":"image","alt":"Logo (PRNewsfoto/Harbour BioMed)","displaySize":"","headline":null,"caption":"Logo (PRNewsfoto/Harbour BioMed)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":159,"url":"https://media.zenfs.com/en/prnewswire.com/47f569ac406a18e992467aae42c1112a"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/QfTD0HAZLEeUnnuJyHFWgQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTI4MA--/https://media.zenfs.com/en/prnewswire.com/47f569ac406a18e992467aae42c1112a","width":400,"height":159},"resize_sm":{"url":"https://s.yimg.com/ny/api/res/1.2/8RL2Zlreu4aGYnLKxlt.MA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTY0MDtoPTI1NA--/https://media.zenfs.com/en/prnewswire.com/47f569ac406a18e992467aae42c1112a","width":400,"height":159}},"href":"https://mma.prnewswire.com/media/1096360/HB_for_email_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"HBM7004 is a novel B7H4xCD3 bispecific antibody developed using the Company's HBICE® platform. This bispecific antibody is designed to provide a differentiated approach to cancer immunotherapy with the potential to enhance both efficacy and safety. The development of HBM7004 further demonstrated the HBICE® platform's versatility and plug-and-play advantages. In preclinical studies, HBM7004 demonstrated an intratumor B7H4-dependent T cell activation manner. In multiple animal models, HBM7004 showed strong anti-tumor efficacy, remarkable in vivo stability, and reduced systemic toxicity. Additionally, in preclinical models, HBM7004 exhibited a strong synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio,...