Harbour BioMed Submits IND Application for HBM9378/SKB378 to Treat COPD

Harbour BioMed, a global biopharmaceutical company based in Cambridge, Mass., Rotterdam, Netherlands, and Suzhou, China, has announced a significant development in its ongoing mission to innovate in the fields of oncology and immunology. On November 8, 2024, the company submitted an Investigational New Drug (IND) application to China’s Centre for Drug Evaluation of the National Medical Products Administration. This application concerns HBM9378/SKB378, a fully human antibody designed to target thymic stromal lymphopoietin (TSLP) for treating chronic obstructive pulmonary disease (COPD).

COPD is a chronic and progressive respiratory illness known for severe complications including cardiovascular issues, respiratory failure, and an increased risk of lung cancer. The disease represents a substantial healthcare burden, leading to increased costs and a profound impact on society. The need for new and effective treatments is pressing, as current options often fall short in alleviating the daily challenges faced by COPD sufferers and improving their overall quality of life.

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, expressed optimism about HBM9378/SKB378, emphasizing its unique advantages over other treatments targeting TSLP. The antibody is fully human, which reduces the risk of immunogenicity and enhances bioavailability. Furthermore, its optimized half-life and superior biophysical properties provide significant benefits in terms of dosing and formulation, making it a promising candidate for addressing the diverse needs of COPD patients.

HBM9378/SKB378 is a result of a collaborative effort between Harbour BioMed and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Both companies share equal global rights to the antibody. The drug is a fully human monoclonal antibody created using the H2L2 platform, which consists of two heavy chains and two light chains. By blocking the interaction between TSLP and its receptor, HBM9378/SKB378 effectively inhibits the TSLP-mediated signaling pathway. This mechanism is designed to provide therapeutic benefits, supported by the drug’s long half-life and favorable dosing properties. The phase I clinical trial for HBM9378/SKB378, aimed at treating moderate-to-severe asthma, has already been completed in China under an IND.

Harbour BioMed is committed to discovering, developing, and commercializing innovative antibody therapeutics with a strong focus on immunology and oncology. The company is expanding its portfolio and pipeline through its robust internal R&D capabilities, strategic collaborations, and selective acquisitions. Harbour BioMed’s proprietary antibody technology platforms, such as Harbour Mice®, generate fully human monoclonal antibodies in both H2L2 and heavy chain only (HCAb) formats. The HCAb-based immune cell engagers (HBICE®) bispecific antibody technology platform is designed to deliver tumor-killing effects that traditional combination therapies cannot achieve. By integrating Harbour Mice® and HBICE® with a single B cell cloning platform, the company has developed a highly efficient antibody discovery engine for next-generation therapeutic antibodies.

Harbour BioMed continues to leverage its innovative platforms and strategic partnerships to advance its mission of bringing novel antibody therapeutics to patients worldwide. As the company progresses with the development of HBM9378/SKB378, it remains focused on meeting the unmet medical needs of patients suffering from debilitating conditions such as COPD.