Cambridge, MA, Rotterdam, NL, Suzhou, CN— July 16, 2021 

Harbour BioMed (“HBM”, HKEX: 02142) today announced last patient dosing in a phase 1b/2a study of its anti-FcRn antibody, batoclimab (HBM9161), for the treatment of acute neuromyelitis optica spectrum disorder (NMOSD). This clinical study aims to assess the safety, tolerability, pharmacodynamics, and efficacy of batoclimab (HBM9161) in patients with NMOSD in China. It is the first anti-FcRn PoC study for the treatment of NMOSD.

Batoclimab (HBM9161) is a fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn) that accelerates the degradation of autoantibodies that drive NMOSD as well as other autoimmune disorders. Based on its novel mechanism and high unmet need in China, HBM has initiated clinical trials in several other autoimmune diseases, including myasthenia gravis, Grave’s ophthalmopathy and adult immune thrombocytopenia(ITP).

"NMOSD is a serious autoimmune disease of the central nervous system. There is no innovative and effective therapeutics available for acute attack of NMOSD. The earlier clinical studies, including our phase 1 trial, demonstrated that batoclimab (HBM9161) has an excellent safety profile and potent IgG reduction capability. We believe this novel mechanism will bring an effective therapeutic to the acute NMOSD patients.” said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

HBM is developing batoclimab (HBM9161) as a pipeline in a product to treat multiple pathogenic-IgG mediated autoimmune diseases with significant unmet medical needs.

About Batoclimab (HBM9161)

Batoclimab (HBM9161), a fully human anti-FcRn mAb, blocks FcRn-IgG interactions, accelerating the degradation of autoantibodies and leads to the treatment of pathogenic IgG-mediated autoimmune diseases. Available evidence suggests that reduced levels of pathogenic IgG in patients with NMOSD are associated with clinical benefit. Earlier studies demonstrated that batoclimab is well tolerated​ and can rapidly reduce total IgG in a wide array of pathogenic IgG-mediated autoimmune diseases, including myasthenia gravis, Grave’s ophthalmopathy, neuromyelitis optica spectrum disorder and immune thrombocytopenia amongst others. HBM licensed batoclimab (HBM9161) from HanAll Biopharma and has the right to develop, manufacture and commercialize in Greater China (including Hong Kong, Macau and Taiwan).

About Neuromyelitis Optica Spectrum Disorder

Neuromyelitis optica spectrum disorder (NMOSD) is a lifelong and debilitating autoimmune disease of the central nervous system (CNS), characterized by inflammatory demyelination in the optic nerve and spinal cord. The main pathogenesis is the binding of pathogenic IgG to AQP4, which leads to complement-dependent cytotoxicity and secondary inflammation, accompanied by infiltration of granulocytes and macrophages, destruction of the blood-brain barrier and oligodendrocytes damage.

The acute attacks or relapses of NMOSD can lead to accumulating, permanent neurological damage, visual impairment and disability, paralysis and blindness. The currently available treatment options for an acute attack in NMOSD are limited, and therapeutic effect is not satisfactory. The purpose of acute attack treatment is to alleviate the symptoms of the attack, shorten the course of the disease, improve the degree of disability and prevent complications.

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 oncology and immunology. 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^® with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies.  

For further information, please refer to www.harbourbiomed.com