Harbour BioMed Announces First Patient Dosing of Phase 1b/2a Study of Anti-FcRn Batoclimab for Treating Neuromyelitis Optica Spectrum Disorder

First anti-FcRn PoC study for the treatment of NMOSD

Anti-FcRn antibody with potential to become a portfolio-in-a-product

CAMBRIDGE,Mass.,ROTTERDAM,Netherlands andSUZHOU,China,April 21,2020 -- Harbour BioMed (HBM) today announced first patient dosing in a Phase 1b/2a study of its anti-FcRn antibody,batoclimab (HBM9161),for the treatment of 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 plans to begin clinical trials this year in several other autoimmune diseases,including myasthenia gravis,Grave's ophthalmopathy,and neuromyelitis optica spectrum disorder.

"With the COVID-19 situation gradually easing in China,we are happy to have successfully achieved the milestone of dosing the first patient. NMOSD is a serious autoimmune disease of the central nervous system with no approved effective treatment. The initial clinical studies,including our Phase 1 trial,demonstrating 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 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. NMOSD is among the first indications that HBM is developing in China.

About Batoclimab(HBM9161)

Batoclimab (HBM9161) is an antibody targeting the neonatal Fc receptor (FcRn). FcRn expression is upregulated by proinflammatory cytokines like TNF-α and extends the half-life of IgGs and serum albumin by reducing lysosomal degradation in endothelial cells and bone-marrow derived cells. Blocking the FcRn-IgG interaction accelerates the degradation of autoantibodies and alleviates the flare-up in wide array of pathogenic IgG-mediated autoimmune diseases,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 (NMO) 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 first attack can lead to accumulating,permanent neurological damage,visual impairment and disability,paralysis and blindness. 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. In 2015,TheInternational PanelforNMODiagnosis (IPND) was convened to develop revised diagnostic criteriaof NMOSD and brought out a new nomenclature which defined the unifying term NMO spectrum disorders (NMOSD).

There is no approved standard treatment of NMOSD. Acute relapses are mainly treated with large doses of glucocorticoid.

About Harbour BioMed

Harbour BioMed is a global,clinical stage biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology and immunological diseases. The company is building its proprietary pipeline through internal R&D programs,collaborations with co-discovery and co-development partners and select acquisitions.

The company's internal discovery programs are centered around its two patented transgenic mouse platforms (Harbour Mice®) for generating both fully human monoclonal antibodies,heavy chain only antibodies (HCAb) and HCAb based bispecific antibodies. Harbour BioMed also licenses the platforms to companies and academic institutions.The company has operations in Cambridge,Massachusetts; Rotterdam,The Netherlands; and Suzhou & Shanghai,China.For more information,please visitwww.harbourbiomed.com