Abnova Develops Fully Human HMGB1 Monoclonal Antibody for the Treatment of Sepsis
Neihu, Taiwan (July 8, 2010)
Abnova Corporation announced today the initiation of an antibody humanization program using a proprietary in vitro immunization plaform for its in-house monoclonal antibody targeting a HMGB1 (high-mobility group box 1) protein involved in sepsis. With only one approved drug (Xigris®) by the FDA and a lack of desirable response to current treatments, sepsis therapy not only represents a great unmet need in the estimated $30 billion USD market but also a therapeutic challenge due to elaborate involvement of many immune cells, intracellular and extracellular proteins, and inflammatory pathways. Nonetheless, Abnova has garnered an extensive collection of HMGB1 antibody and protein research tools which have become one of the best selling and widely published products in the industry. HMGB1 protein has also proven to be a significant contributor to sepsis as evidenced by several successful validations in animal models. With almost complete homology between mouse and human HMGB1 gene, the development of a fully human antibody therapeutic against HMGB1 will propel the validation and application of antibody treatment for sepsis in human patients. Abnova aims to complete the full humanization of HMGB1 monoclonal antibody utilizing the more advanced in vitro immunization platform by 2011, ahead of its original schedule of utilizing conventional mouse monoclonal antibody humanization platform by 2013 and initiation of human clinical trial in 2015.
Fully human monoclonal antibody produced from in vitro immunization platform possesses the same quality of the natural monoclonal antibody in human immune system. It has no mouse counterpart gene in its antibody backbone, and its combined antibody light chain and heavy chain originate from the same immune B cell. It is distinguished from humanized monoclonal antibody generated by (1) CDR drafting platform which still carries a 5-10% residual mouse gene, (2) phage display and (3) transgenic mouse platforms in which the antibody light chain and heavy chain are from different B cells. Contamination of mouse gene and less natural combination of antibody light chain and heavy chain are major causes of immune side effects in clinical trials which are under increased scrutiny by the FDA. After immortalization and screening of HMGB1 monoclonal antibody, Abnova will perform functional testing of its antibody on in vitro cell and animal models followed by optimization of monoclonal antibody expression in a mammalian system. Aided by Abnova’s existing and well-established bio-tools for qualitative and quantitative studies, and extensive experience in antibody drug candidate custom manufacturing for large pharmaceutical companies, Abnova’s HMGB1 antibody drug development can be greatly accelerated thereby shortening the time to human clinical trial.
HMGB1 is our body’s crucial pro-inflammatory cytokine in response to both injury and infection. The temporal characteristic which makes HMGB1 an ideal target for treatment of sepsis while other therapies have failed is its late-onset of release by the human body. This is because other early onset cytokines does not allow sufficient time for therapeutic intervention. Abnova has also selected the HMGB1 target for fully human monoclonal antibody development based on a stringent set of market, technical, intellectual property, preclinical and clinical criteria. In addition to a nascent yet large antibody therapeutic market of sepsis, HMGB1 is amenable to targeting by a monoclonal antibody, has a thorough and well-studied cDNA sequence and expression profiles, a freedom to operate in the intellectual property arena, and strong correlative preclinical models for antibody functional testing and analysis prior to human clinical trial. Besides sepsis, fully human HMGB1 monoclonal antibody drug maybe used for the treatment of inflammatory disease such as arthritis and diabetes, and also cancer.
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About Abnova
Abnova is the world’s largest monoclonal antibody manufacturer. The system Abnova has developed is a unique combination of world-class technologies and management experience of the IT industry in Taiwan. By taking a genome-wide, approach to industrial-scale production, the company has vastly expanded the scope and availability of monoclonal antibodies which are the essential bio-tools for accelerating all facets of research and discovery in the biotech and pharmaceutical industries. Abnova intends to leverage its antibody capability to the creation and development of antibody integrated systems, point-of-care in vitro diagnostics (IVD), and fully human monoclonal antibody therapeutics for the treatment of infection and cancer. ( www.abnova.com)
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