Milestone: Fountain Biopharma Allergy Treatment New Drug Approved for Phase I Human Clinical Trials

The Anti-CemX monoclonal antibody drug FB825 under development by Fountain Biopharma had been officially approved by United States FDA for Phase I human clinical trials on September 25, 2014. It is Fountain Biopharma’s first antibody new drug approved for human clinical trials, and an important development milestone for the company.
This product was a technology transfer from Academia Sinica to Fountain Biopharma, after much effort, the milestone for approval for human clinical trials has been achieved. In the area of intellectual property protection, patents have been officially approved from the United States, Australia, South Africa, and other countries, fully protecting the intellectual property of the product. In terms of new drug development, multiple in vitro, in vivo, human physical and safety related tests had been administered, proving that FB825 is a highly safe drug, which can effectively deplete mIgE+B lymphocytes, and inhibit biological activity of IgE. The IND application was submitted to the FDA after completing pre-clinical toxicology studies and GMP compliant manufacturing. It sets a good example of a commercialization effort from a licensed product from research institution.
In addition, during the development of FB825, Fountain Biopharma received the support and several recognitions from the Ministry of Economic Affairs (MOEA) on New Drug and Industry Development Technology Program. Fountain Biopharma has established a complete development value chain for new drugs, and will continue to push forward the product line of antibodies into human clinical trial, with unlimited potential for future development.