KaloBios Pharmaceuticals, Inc. recently announced that data from its phase I study on KB001 has been published online in the journal Pediatric Pulmonology. KB001 is a first generation, anti-pseudomonas aeruginosa (Pa) type III secretion system (TTSS) antibody, being developed for patients with cystic fibrosis (CF).
KB001 is a precursor molecule to KB001-A. KB001-A, a second generation, anti-TTSS antibody, is currently in a phase II study for the treatment of chronic Pa infections in CF patients. While KaloBios has orphan drug status for KB001-A in the EU, the U.S. Food and Drug Administration (FDA) has completed its review for the same and has asked for additional information.
After the completion of the ongoing phase II CF study, KaloBios will provide the FDA with additional data. Enrollment is expected to complete in mid-2014 with top-line results due in the fourth quarter of 2014.
We note that KaloBios has a development and commercialization agreement with Sanofi (SNY - Analyst Report) for KB001-A. As per the agreement, Sanofi is responsible for bearing the cost of research, development, manufacture, and commercialization of the licensed products for the diagnosis, treatment and/or prevention of all human diseases and conditions caused by Pa. KaloBios will bear the cost of development and promotion of the products for the diagnosis, treatment and/or prevention of Pa in patients with CF or bronchiectasis.
The FDA has granted Fast Track designation to KB001-A to Sanofi for the prevention of bacterial pneumonia caused by Pa in mechanically ventilated patients.
KaloBios carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Gilead Sciences Inc. (GILD - Analyst Report) with a Zacks Rank #1 (Strong Buy), and Jazz Pharmaceuticals (JAZZ - Analyst Report) with a Zacks Rank #2 (Buy).