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Harbour BioMed Announces Dosing of First Patient of Batoclimab Phase III Trial in Patients with Generalized Myasthenia Gravis

September 27, 2021

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Harbour BioMed Announces Dosing of First Patient of Batoclimab Phase III Trial in Patients with Generalized Myasthenia Gravis

September 27, 2021

Cambridge, MA, Rotterdam, NL, Suzhou, CN— September 27, 2021


Harbour BioMed (“HBM”, HKEX: 02142) announced that, the clinical trial of its anti-FcRn antibody, batoclimab (HBM9161), has completed the first dosing of first patient in registrational phase III trial for the treatment of generalized myasthenia gravis (gMG). This clinical study aims to assess the efficacy and safety of batoclimab in patients with gMG in China. It is a subsequent milestone to the announcement of positive outcome of the first anti-FcRn proof of concept study for the treatment of gMG completed in August 2021. As the first anti-FcRn therapy which achieved clinical evidence in China, data received from the phase II study showed a statistically significant and clinically meaningful efficacy of batoclimab, as well as a favorable safety and tolerability profile.


HBM is developing batoclimab as a pipeline in a product to treat multiple pathogenic-IgG mediated autoimmune diseases with significant unmet medical needs. gMG is among the first of such multiple indications for which HBM is developing drug candidates in China and this therapy has been granted “Breakthrough Therapy Designation” by the Chinese NMPA in early 2021.


“Data received from the phase II clinical trial of batoclimab in Chinese gMG patients showed the efficacy of batoclimab over placebo, a favorable safety and tolerability profile. The positive results also indicate that FcRn antagonist can improve the condition of gMG patients rapidly and significantly, manifesting the application potential in other autoantibody-mediated autoimmune diseases”, said the principal investigator Chongbo Zhao, MD, Professor of Neurology at Huashan Hospital of Fudan University in Shanghai.


"For decades, there has been lacking adequate and effective therapies for treating myasthenia gravis patients in China, especially for those refractory patients, patients potentially progressing to life-threatening myasthenic crisis, and patients affected by severe side effects associated with long-term use of current therapies, who are yearning for safe and efficacious novel therapeutics. The first patient first dosing in the phase III study brings us one step closer to deliver the novel therapeutic and we look forward to receiving more evidence soon to support batoclimab as the promising potential novel treatment for gMG patients.” said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.


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. Phase 2 study in myasthenia gravis showed that batoclimab can quickly and significantly alleviate patients’ symptoms and improve quality of life. Earlier studies demonstrated that batoclimab is well tolerated​ and can rapidly reduce total IgG in a wide array of pathogenic IgG-mediated autoimmune diseases. 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 Generalized Myasthenia Gravis (gMG)


Myasthenia gravis (MG) is an acquired autoimmune disease mediated by antibodies such as anti-acetylcholine receptor (AChR) immunoglobulin G (IgG) antibody and anti-muscle-specific tyrosine kinase (Anti-MuSK) IgG, which involves the postsynaptic membrane of the neuromuscular junction, causes impaired transmission at the neuromuscular junction, and presents with skeletal muscle contraction weakness. Patients often have ocular muscle manifestations, and about 85% of patients will show symptoms other than ocular muscles and develop generalized myasthenia gravis (gMG), and some patients even develop myasthenic crisis.


Current main treatments for MG include cholinesterase inhibitors and glucocorticoids and other immunosuppressive drugs, but the efficacy and safety cannot meet the clinical needs of many patients. Targeting reduction of pathogenic IgG autoantibodies is a pathophysiological mechanism driven solution in MG treatment, such as plasmapheresis and intravenous immunoglobulin, however, there still remains a significant unmet need for these treatment options, including the accessibility, safety and economic cost. 


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® 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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