Harbour BioMed Announces Dosing of First Patients in Two Phase II Clinical Studies of Batoclimab (HBM9161) for the Treatment of Myasthenia Gravis and Immune Thrombocytopenia

CAMBRIDGE, Mass. and ROTTERDAM, Netherlands and SUZHOU, China, Sept. 30, 2020 /PRNewswire/ -- Harbour BioMed (HBM), a global, clinical-stage, bio-pharmaceutical company announced today the dosing of the first patient in two separate Phase II clinical trials of Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), in mainland China. These studies are designed to evaluate the efficacy and safety of Batoclimab for the treatment of Myasthenia Gravis (MG) and adult Immune thrombocytopenia (ITP) patients.

Batoclimab, a fully human anti-FcRn mAb, blocks FcRn-IgG interactions, accelerating the degradation of autoantibodies and lead to the treatment of pathogenic IgG-mediated autoimmune diseases. Earlier studies show Batoclimab is well tolerated and can rapidly reduce total IgG. These findings make Batoclimab the first anti-FcRn to demonstrate a sustained IgG reduction in both Chinese and Caucasian populations when administered via subcutaneous (SC) injection. With multiple trials ongoing simultaneously in MG, ITP, Graves' ophthalmology (GO) and neuromyelitis optica spectrum disorder (NMOSD), Batoclimab is on its way to become a portfolio-in-a-product.

MG is a severely debilitating condition that manifests itself in the form of skeletal muscle contraction and weakness limiting movement and could even result in fatal respiratory failure. In China, an estimated 250,000 patients suffer from this condition. Current therapies are limited due to inadequate efficacy, safety issues or limited availability.

Adult ITP is an autoimmune bleeding disorder that drives abnormally low platelet levels leading to bruising, spontaneous bleeding, and an increased risk of potentially fatal internal organ bleeding events. Current treatment options including splenectomy, anti-CD-20 mAb and others are limited due to inadequate efficacy and significant side effects. Recognizing the unmet need for these patients, the Chinese NMPA approved a seamless ph. II/III clinical trial of Batoclimab in ITP, which will significantly accelerate the availability of this next-generation treatment for patients.

"We are excited to make strides with the enrollment of the patients for both MG and ITP trials. Given our commitment to drive next generation of therapeutics, Batoclimab is expected to bring life changing solutions for large numbers of patients in China," said Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed. "The dosing of the first patient in the Ph II trials is only a start, and we will continue to accelerate the development of Batoclimab to treat patients with MG and ITP."

About Harbour BioMed

Harbour BioMed is a global, clinical development stage, biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology, immunologic diseases, and COVID-19.  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 HBICE™ immune cell engager technology for developing 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 visit: www.harbourbiomed.com

Media and Investor Contact:

Atul Deshpande PhD, MBA
Chief Strategy Officer and Head, US Ops.
Harbour BioMed
Phone: +1-908-210-3347
E-mail: atul.deshpande@harbourbiomed.com

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