BioWa, Inc. announced that it is beginning its phase 1 clinical trial to evaluate the safety and tolerability of BIW-8405, BioWa's anti-IL-5 receptor monoclonal antibody (Mab). The Mab is being developed for the treatment of asthma.
"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, Inc. "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."
"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 L. Spitalny, Ph.D., BioWa's senior vice president of research and development.
The IL-5 receptor 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. BIW-8405 is being developed to reverse the debilitating effects of asthma by acting to eliminate eosinophils that accumulate locally in the lung.
The overall market for BIW-8405 could potentially gross over $500million worldwide peak sales. The number of patients affected by asthma is growing significantly. The asthma market is predicted to increase from the current $12 billion to over $19 billion worldwide by the year 2009.
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.