Sanofi Pasteur and KaloBios Pharmaceuticals have announced the issuance of FDA fast track designation for novel biologic candidate KB001A targetting Pseudomonas Aeruginosa (Pa).
An antibody fragment KB001A is developed against Pa that causes pneumonia in mechanically-ventilated patients.
Sanofi Pasteur research and development senior vice president Michel DeWilde said, "Sanofi Pasteur is currently targeting the antibody for use in primary prevention of Pa-associated pneumonia in mechanically ventilated patients in hospitals and we are also interested in providing prevention of relapses and improvement of treatment outcomes in patients with an ongoing Pa infection."
Under the terms of the agreement signed between the countries, Sanofi has global rights KaloBios' KB001A technology for indications related to Pa infections, except cystic fibrosis and bronchiectasis, with an option to obtain them in the future.
At present Sanofi Pasteur is conducting a phase I trial of the monoclonal antibody in the US and is planning a phase IIb study.
KaloBios president and CEO David Pritchard said, "KB001's novel mechanism of action against Pa may provide a unique means of fighting these infections, which are often resistant to antibiotic therapies."