{"id":22877,"date":"2023-01-13T22:57:00","date_gmt":"2023-01-13T14:57:00","guid":{"rendered":"https:\/\/flcube.com\/?p=22877"},"modified":"2025-01-24T22:59:26","modified_gmt":"2025-01-24T14:59:26","slug":"harbour-biomeds-hbm1020-receives-fda-approval-for-us-phase-i-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=22877","title":{"rendered":"Harbour BioMed’s HBM1020 Receives FDA Approval for US Phase I Study"},"content":{"rendered":"\n

Harbour BioMed (HKG: 2142<\/a>), a global biotech company operating in the Netherlands, the United States, and China, has announced receiving approval from the US Food and Drug Administration (FDA) to conduct an open-label, multi-center Phase I study of its monoclonal antibody (mAb) HBM1020. The study will assess the safety, tolerability, pharmacokinetics, and antitumor activities of HBM1020 in patients with advanced solid tumors.<\/p>\n\n\n\n

HBM1020: Mechanism and Preclinical Data<\/strong>
HBM1020 is the world’s first monoclonal antibody targeting B7H7, developed using the H2L2 transgenic mouse platform. The antibody enhances anti-tumor immunity by blocking the binding of the immune checkpoint target and its ligand. Preclinical data have confirmed HBM1020’s immune activation and anti-tumor functional activity. B7H7, a newly discovered member of the B7 family, is expressed in various refractory tumors and is closely associated with tumor cell immune escape. Importantly, B7H7 is independent of PD-L1 expression and is often highly expressed in PD-L1-negative tumors, making it a promising target for cancer immunotherapy.<\/p>\n\n\n\n

Clinical Development and Future Outlook<\/strong>
The Phase I study of HBM1020 represents a significant step forward in the clinical development of this innovative therapy. By targeting B7H7, HBM1020 has the potential to address significant unmet needs in the treatment of advanced solid tumors, particularly in patients with PD-L1-negative cancers. Harbour BioMed’s global presence and expertise in biotechnology position the company to drive the development of HBM1020 and bring this novel treatment option to patients worldwide.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Harbour BioMed (HKG: 2142), a global biotech company operating in the Netherlands, the United States,…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,62,190,916,25],"class_list":["post-22877","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-harbour-biomed","tag-hkg-2142","tag-potential-first-in-class"],"yoast_head":"\nHarbour BioMed's HBM1020 Receives FDA Approval for US Phase I Study - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Harbour BioMed (HKG: 2142), a global biotech company operating in the Netherlands, the United States, and China, has announced receiving approval from the US Food and Drug Administration (FDA) to conduct an open-label, multi-center Phase I study of its monoclonal antibody (mAb) HBM1020. 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