#None #HBM9378 #Harbour BioMed #Anti-TSLP

Harbour BioMed Initiates Phase 2 POLARIS Trial for HBM9378/WIN378

In a significant development for asthma therapies, Harbour BioMed, a leading global biopharmaceutical company, has commenced a Phase 2 clinical trial entitled POLARIS. This study focuses on HBM9378/WIN378, a long-acting, fully human anti-TSLP (thymic stromal lymphopoietin) antibody. The POLARIS trial, which is global in scope, aims to assess both the safety and efficacy of this innovative therapy in asthma patients. With an announcement made on July 23, 2025, the company is anticipating initial data results to surface by mid-2026.

Asthma is not merely a mere inconvenience; it impacts approximately 300 million individuals globally, and its prevalence continues to rise at an alarming rate. Current treatments, primarily inhaled corticosteroids and bronchodilators, often fail to provide adequate relief for many patients. Consequently, there is an urgent demand for new, long-acting solutions that specifically target the fundamental mechanisms underlying asthma.

HBM9378/WIN378 stands out due to its unique mechanism. As a monoclonal antibody that targets TSLP, it has been highlighted as potentially best-in-class. Notably, the antibody's fully human sequence minimizes the risk of immunogenicity, a significant advantage over other therapies targeting TSLP. Its design allows for extended dosing intervals, specifically the potential for administration twice a year, which could dramatically reduce the treatment burden for patients grappling with chronic respiratory diseases.

Previous Phase 1 trials of HBM9378/WIN378 showcased promising results, revealing a prolonged half-life along with a low incidence of antidrug antibodies. The therapy was well tolerated by participants, establishing a solid foundation for its advancement into larger scale studies. According to Dr. Jingsong Wang, the Founder and CEO of Harbour BioMed, "We are excited about HBM9378/WIN378's advancement. It has shown great promise in preclinical and clinical investigations, demonstrating potential to meet the substantial needs of asthma patients."

The origins of HBM9378/WIN378 trace back to a collaborative project between Harbour BioMed and Kelun-Biotech, with both companies sharing global rights. Earlier this year, a strategic partnership formed with Windward Bio granted them exclusive rights to research, develop, and commercialize HBM9378/WIN378 globally, apart from several specific territories in Greater China and South East Asia.

Beyond asthma, HBM9378/WIN378 is also being explored as a treatment for COPD (chronic obstructive pulmonary disease). In November 2024, an Investigational New Drug application was submitted to China's National Medical Products Administration for HBM9378/WIN378 for the treatment of COPD, receiving approval in January 2025. Windward Bio's plans include starting global trials for COPD in 2026. The promising advancements of HBM9378/WIN378 in addressing both asthma and COPD underscore the therapy's versatility and potential impact on patient care.

About Harbour BioMed
Founded on innovation and commitment, Harbour BioMed aligns its mission with the pressing need for modern therapeutics in immunology and oncology. The company is leveraging its proprietary antibody technology platform, Harbour Mice®, which efficiently generates fully human monoclonal antibodies effective against a range of diseases. Their pipeline continues to expand through strategic collaborations, reflecting their dedication to advancing biopharmaceutical discoveries.

About Windward Bio AG
Windward Bio stands at the forefront of biotechnology, focusing on the advancement of therapeutic solutions for patients confronting severe immunological challenges. Their flagship program encompasses WIN378, the long-acting anti-TSLP monoclonal antibody currently in clinical development for asthma. With a robust strategy bolstered by significant funding and strong investor backing, Windward Bio aims to deepen its pipeline while addressing various respiratory and immunological conditions.

As we await the results of the POLARIS trial, the scientific community and asthma patients alike hold high hopes for HBM9378/WIN378, a therapy that could reshape management strategies for chronic respiratory diseases.