Development of Anti-IgE Monoclonal Antibody for Treatment of Allergic Diseases
Presenter: Dr. Cheng Peng
Senior Scientist, Tanox, Inc.
摘要：
IgE is a key component driving pathological allergic reactions. Over 100 million people suffer form various IgE-mediated allergic diseases including asthma, allergic rhinitis, atopic dermatitis, food and drug allergies, and severe reactions to insect stings. Scientists at Tanox Inc. discovered a way to neutralize the activity of the IgE molecule, and target the cells producing it, without triggering allergic reactions. A unique monoclonal antibody able to bind to IgE in the circulation, and to cells producing IgE, and able to neutralize the activity of IgE by preventing it from binding to IgE receptors was identified, and its activity and specificity fully characterized in the laboratory. The antibody was genetically engineered by humanization to make it more compatible and effective for use in humans.
Anti-IgE has been shown to be safe and efficacious in Phase II and Phase III clinical trials in allergic rhinitis and Phase II trials in allergic asthma, Phase III trials in allergic asthma are underway. In these trials, patients treated with anti-IgE had fewer symptoms than patients treated with placebo, used fewer allergy and asthma medications, such as anti-histamines and steroids, and suffered fewer asthma exacerbations requiring emergency treatment or bursts of increased steroids medications. Anti-IgE has had a "placebo-like" safety profile.
The anti-IgE partners (Tanox, Novartis and Genentech) plan to file applications to US and EU drug regulatory authorities next year to obtain approval to market the anti-IgE product rhumabE25 (E25).