Harbor BioMed Announces IND Approval for Phase II Trial of Anti-FcRn Batoclimab in Chronic Inflammatory Demyelinating Polyneuropathy in China

CAMBRIDGE, Mass. and ROTTERDAM, Netherlands and SUZHOU, China, Sept. 1, 2021 / PRNewswire / – Harbor BioMed (“HBM”, HKEX: 02142) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the new investigational drug (IND) request to initiate a phase II trial of anti-FcRn batoclimab in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

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

Based on the new batoclimab mechanism and on high unmet medical needs in China, HBM has initiated clinical trials in several autoimmune diseases with reported positive results, including myasthenia gravis, Grave’s ophthalmopathy, adult immune thrombocytopenia (ITP) and neuromyelitis optic spectrum disorder (NMOSD).

CIDP is a chronic, progressive disease characterized by progressive weakness and impaired sensory function of the legs and arms and is closely related to Guillain-Barré syndrome. Pulsed corticosteroids and intravenous immunoglobulin (IVIg) are common therapies for patients with CIDP, but they can hardly meet the increasing medical needs of patients in terms of side effects and drug availability.

“Due to the side effects of steroids and limited access to IVIG, there are still many unmet medical needs to explore new effective and practical therapies for CIDP. We believe that this new mechanism will provide safe and effective therapy for patients with CIDP. We are committed to further accelerating this exciting new therapeutic development to help Chinese patients by need,” said dr. Jingsong Wang, Founder, CEO of Harbor BioMed.

About the 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 autoimmune diseases mediated by IgG. A phase 2 study in myasthenia gravis showed that batoclimab can quickly and significantly relieve symptoms in patients and improve quality of life. Previous studies have demonstrated that batoclimab is well tolerated and can rapidly reduce total IgGs in a wide range of pathogenic IgG-mediated autoimmune diseases. HBM licensed batoclimab (HBM9161) from HanAll Biopharma and has the right to develop, manufacture and market in Greater China (including Hong Kong, Macau and Taiwan).

About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

CIDP is a chronic, progressive disease characterized by progressive weakness and impaired sensory function of the legs and arms and is closely related to Guillain-Barré syndrome. Corticosteroid pulses after high-dose maintenance of prednisone or intravenous immunoglobulin (IVIG) are common therapies for patients with CIDP, with about two-thirds of patients requiring IVIG for many years. Due to the side effects of steroids and limited access to IVIG, there are still many unmet medical needs to explore new effective and practical therapies for CIDP.

About Harbor BioMed

Harbor BioMed (HKEX: 02142) is a global biopharmaceutical company engaged in the discovery, development and commercialization of novel therapeutic antibodies focused on immunology and oncology. The Company builds its solid portfolio and differentiated pipeline through internal R&D capabilities, collaborations with co-discovery and co-development partners and selected acquisitions.

Harbor Mice’s proprietary antibody technology platforms® generate fully human monoclonal antibodies in two heavy chain and two light chain format (H2L2), as well as heavy chain only format (HCAb). Based on anti-HCAb antibodies, HCAb-based immune cell activators (HBICE ™) are capable of producing tumor-killing effects not achievable by traditional combination therapies. Integration of house mice® With a single B cell cloning platform, our antibody discovery engine is very unique and efficient for the development of next generation therapeutic antibodies.

For more information, please visit www.harbourbiomed.com

SOURCE Port BioMed

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