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BioWa begins Phase 1 clinical Mab trial in asthma

By Wai Lang Chu , 31-Oct-2006

BioWa has announced it is to commence Phase 1 clinical trials anti-IL-5 receptor monoclonal antibody (Mab), which is being developed for the treatment of asthma, a respiratory disorder that is on the rise, particularly in children.

The Mab targets the IL-5 receptor, which is expressed predominantly on the surface of a class of white blood cells known as eosinophils. These are one of several types of white blood cells that act to combat infection.

However, in a more negative action, eosinophils have been implicated as the major cause of problems in the lung associated with various forms of asthma.

The Mab - BIW-8405, is being developed to reverse the debilitating effects of asthma by acting to eliminate eosinophils that accumulate locally in the lung.

It is hoped this therapy can eventually enter a market that is predicted to increase from the current $12bn (€9.5bn) to over $19bn worldwide by the year 2009.

The overall market for BIW-8405 could potentially gross over $500m worldwide peak sales as number of patients affected by asthma is growing significantly. Latest figures show that globally, asthma is responsible for around 180,000 deaths annually.

"The commencement of the BIW-8405 clinical studies is a significant step for BioWa's technology platform, demonstrating our commitment to building a pipeline of Antibody-Dependent Cellular Cytotoxicity (ADCC) enhanced therapeutic products, positioning BioWa as a key player in asthma therapeutics," said Dr. Nobuo Hanai, President and CEO of BioWa.

"We believe that ADCC enhancement of antibodies will overcome many existing problems of antibody therapeutics today. We are pursuing the discovery and development of high value proprietary therapeutic products through the use of Potelligent Technology."

ADCC activity is an important function of the human immune system, whereby immune cells can kill target cells, e.g. cancer cells.

Several anti-cancer therapeutic antibodies that are on the market today have ADCC activity as one of their mechanisms for the killing of tumour cells.

Enhancement of this activity is one promising approach in the next generation of antibody technologies.

Potelligent technology involves the reduction of the amount of fucose in the carbohydrate structure of an antibody using a proprietary fucosyltransferase-knockout CHO cell line as a production cell.

Research shows that Potelligent technology significantly enhances ADCC activity of an antibody in vitro, thereby increasing the potential for improved activity in vivo.

"Moving forward with our clinical program for BIW-8405 is an exciting step for BioWa, especially since this is the first Mab of the BioWa pipeline to enter human trials," said George Spitalny, BioWa's senior Vice President of research and development.

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