Astellas Pharma Inc. (Headquarters, Tokyo; President & CEO, Yoshihiko Hatanaka) today announced that the administration of the seasonal influenza HA vaccine ASP7374 (former code: UMN-0502) was successfully completed in the currently ongoing phase I/II clinical trial. Astellas Pharma has been pursuing drug development of this vaccine in cooperation with UMN Pharma Inc. (Headquarters, Akita; CEO, Shu-ichi Kanazashi).
This clinical study enrolled 165 healthy adult volunteers, and aims to comparatively evaluate the immunogenicity and safety of two subcutaneous and one intramuscular doses of ASP7374 to determine the optimal clinical dose.
The seasonal influenza HA vaccine ASP7374, which contains three different strains of antigens, has been produced by the cell-culture manufacturing method employing the Baculovirus Expression Vector System (BEVS), a next-generation technology platform for manufacturing of biopharmaceutical products. In USA, Protein Sciences Corporation has completed all clinical studies required for approval, and submitted a Biologic License Application of this vaccine to the Food and Drug Administration.