KaloBios Pharmaceuticals, Inc.
) recently announced that data from its phase I study on KB001
has been published online in the journal
. 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
) 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.
) with a Zacks Rank #1 (Strong Buy), and
) with a Zacks Rank #2 (Buy).
GILEAD SCIENCES (GILD): Free Stock Analysis
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
KALOBIOS PHARMA (KBIO): Free Stock Analysis
SANOFI-AVENTIS (SNY): Free Stock Analysis
To read this article on Zacks.com click here.