CAMBRIDGE, Mass. and ROTTERDAM, Netherlands and SUZHOU, China, June 1, 2022 /PRNewswire/ -- Harbour BioMed (the "Company", HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics, today announced the progress of its dual MOA of CTLA-4 inhibition and Treg depletion, next-generation fully human heavy-chain antibody (HBM4003) with studies of monotherapy and combination therapy with anti-PD-1 antibody. The two abstracts have been published on the American Society of Clinical Oncology (ASCO) website and will be presented at this year's ASCO Annual Meeting.
Abstract One:
Study title: A Phase I Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of HBM4003 in Subjects with Advanced Solid Tumors
Abstract number: 2641
Poster number: 296
Abstract Two
Study title: A Phase I Open-label Study to Evaluate the Safety, Tolerability, PK/PD and Anti-tumor Activity of HBM4003 in Subjects with Advanced Melanoma and Other Solid Tumors
Abstract number: e14586
Particularly in the study of HBM4003 in combination with toripalimab, another PR from a urothelial carcinoma patient (3 lines of previous treatments including toripalimab) was observed at the end of 2021. As of the date of issue, the patient recruitment of the dose-expansion part in this study has been completed.
Commenting on the studies' results, Dr. Humphrey Gardner, CMO of Harbour BioMed, said, "we are excited to observe the promising efficacy and excellent safety profile of HBM4003 and its potential to lead the development of next-generation therapy of immuno-oncology for multiple solid tumors. The Treg depleting activity of HBM4003 offers a potential for clinical efficacy in indications hitherto unaddressed by first generation CTLA4 inhibitors. The clinical results obtained so far have given us the confidence for further global development of HBM4003, and further relevant study results will be published in the upcoming academic conferences."
As the Company further implements its global innovation and development strategy, it will continue to fully commit to advancing the global clinical development project of HBM4003, as part of its broad and innovative immuno-oncology pipeline to address the significant unmet medical needs in multiple solid tumor indications.
About HBM4003
HBM4003 is a fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice®. It is the first fully human heavy-chain-only monoclonal antibody entered into clinical stage globally. By enhancing antibody-dependent cell cytotoxicity (ADCC) killing activity, HBM4003 has demonstrated significantly improved depletion specific to high CTLA-4 expressing Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug in monotherapy and combination therapy.
About Harbour BioMed
Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions.
The Company's proprietary antibody technology platforms Harbour Mice® generate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) are capable of delivering tumor killing effects unachievable by traditional combination therapies. Integrating Harbour Mice®, HBICE® with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies.
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