mrc

First Alzheimer’s patient treated with BAN2401, a novel antibody targeting the neurotoxin believed to cause Alzheimer’s disease

(London, UK, 06 September 2010) MRC Technology announced today that BAN2401, the antibody it humanized for Swedish biopharmaceutical company BioArctic Neuroscience AB (Stockholm), has entered clinical trials to treat patients with Alzheimer’s disease. The antibody is licensed by BioArctic Neuroscience AB to Japanese pharmaceutical company Eisai Co., Ltd. (Tokyo) who is conducting the trials.

BAN2401 is an antibody that targets the toxic amyloid aggregates believed to cause degeneration of brain cells leading to Alzheimer’s disease. The new treatment approach is expected to halt progression of the disease.

The study will primarily evaluate the safety of BAN2401 to determine a safe dose range and its effects on Alzheimer biomarkers. More than 80 Alzheimer’s patients with mild to moderate forms of the disease will participate. BAN2401 is the first monoclonal antibody to selectively bind and efficiently eliminate amyloid-β protofibrils, the toxic protein believed to cause Alzheimer’s disease.

The role of monoclonal antibody therapies in treating medical conditions has expanded tremendously since the first such therapy was developed in the 1970s by the UK’s Medical Research Council, and their use in treating neurological conditions has only increased in the past few years.

MRC Technology’s Tarran Jones, Director of their Therapeutic Antibody Group (TAG) said, ”Once again our antibody humanization process has proven to be one of the best ways to deliver robust antibody-based clinical candidates for the biotechnology and pharmaceutical industry. Our worldwide record of success shows the confidence our partners have in our ability to engineer therapeutic antibodies.”

MRC Technology will receive clinical development milestones as BAN2401 enters into and progresses through clinical trials as well as royalties on sales. Additional financial terms were not disclosed.

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Notes to editors

Antibody BAN2401

Current research suggests that an intermediate (Aβ protofibril) in the aggregation process of the amyloid-β peptide Aβ initiates and drives the neurodegenerative process in Alzheimer’s disease. These Aβ protofibrils have been proven to be toxic elements of the disease in a number of studies in transgenic animals with the Arctic and Swedish mutations (APParcswe), published by Prof. Lars Lannfelt, Uppsala University. BioArctic Neuroscience has developed a humanized monoclonal antibody (BAN2401) that selectively eliminates these toxic Aβ protofibrils. Eisai has obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of Alzheimer’s disease. BioArctic retains the rights to market the antibody in Nordic countries and use it for other medical indications. 

Antibody Humanization

Antibody humanization, also known as CDR-grafting (CDR is a synonym for complementarity determining region) was first invented at the MRC Laboratory of Molecular Biology in the UK by Dr. Sir Greg Winter and patented by the MRC in the late 1980's. CDR-grafting involves the genetic transfer of mouse CDRs (which are responsible for antigen binding) into human frameworks of a variable region. A variable region is one domain of an immunoglobulin chain, a whole antibody itself comprising of one light and one heavy immunoglobulin chain. The key to success in antibody humanization is the careful analysis of the mouse antibody to identify key framework residues important for the preservation of antibody function in the humanized antibody.

Alzheimer’s Disease

Alzheimer’s disease is a devastating neurodegenerative disease characterized by an insidious onset and progressive loss of memory and cognition. The disorder is also manifested by behavioural disturbances and functional impairment, and leads to premature death.

Alzheimer’s disease is a demographic time bomb. The disease is age-related and the number of patients doubles every five years beyond age 65, meaning that 30% of 85-year-olds are suffering from the disease. Today, an estimated 15 million people worldwide are affected by Alzheimer’s, and researchers estimate that this number could increase to around 70 million by 2050. In the United States, the annual cost for treatment, care, and loss to business as a result of Alzheimer’s disease is estimated at €100 billion. This figure is expected to continue to grow as the average age of the population increases.

Alzheimer’s disease represents an area of high unmet medical need, as there is currently no treatment that can cure or stop the disease. The world market for an effective Alzheimer’s drug is estimated at €12 billion. Halting disease progression would lead to enormous benefits to patients and caregivers and cost savings for society given the huge cost of patient care.

About Medical Research Council Technology (MRC Technology)

MRCT is the exclusive commercialisation agent for the UK Medical Research Council, working to translate cutting edge scientific discoveries into commercial products. MRCT bridges the gap between innovative basic science and making medicine. MRCT works to provide drug-like candidate molecules to innovative new drug targets, and to translate innovative antibody-based drug targets into potent and selective therapeutic antibody candidates giving pharmaceutical and biotechnology companies new starting points for drug discovery and development, based on MRC advances in science.   MRCT’s Therapeutic Antibody Group (TAG) scientists have a proven track record of success in antibody humanization. Over the past 22 years TAG scientists have successfully humanized nearly 50 rodent antibodies, of which 10 have progressed as clinical candidates and two have secured regulatory approval worldwide: Elan/Biogen Idec’s Tysabri® and Chugai/Roche’s Actemra®.

www.mrctechnology.org

About BioArctic Neuroscience

BioArctic Neuroscience AB is a biopharmaceutical company with a proprietary technology for developing therapeutic monoclonal antibodies for the treatment of Alzheimer’s disease, Parkinson’s disease, and other disorders caused by misfolded proteins.

www.bioarctic.se

About Eisai Co., Ltd

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs approximately 11,000 employees worldwide.

Contact Information:

Medical Research Council Technology (MRCT):

Suzy Hargreaves

E-mail:   shargreaves@tech.mrc.ac.uk

Phone:   +44 (0)20 7391 2798