Date: 2014-07-28
Type of information: Termination of an agreement
Compound: KB001A
Company: KaloBios Pharmaceuticals (USA -CA) Sanofi Pasteur (France)
Therapeutic area: Infectious diseases - Respiratory diseases - Lung diseases
Type agreement: collaboration licensing
Action mechanism: KB001A, a Humaneered™ antibody fragment, is designed to fight Pseudomonas aeruginosa (Pa) by blocking a virulence mechanism (the Type Three Secretion System or TTSS) on the bacterium\'s external surface that enables Pa to evade human immune defenses by killing white blood cells and epithelial cells, and triggering tissue-damaging inflammation. By blocking Pa\'s killing mechanism, KB001A is intended to reduce the damage done to the lungs by Pa and potentially enable the patient\'s own immune system to effectively fight and clear the bacteria from sites of infection.
Disease: Pseudomonas aeruginosa pneumonia
Details: * On July 28, 2014, KaloBios Pharmaceuticals announced that it has reached an agreement with Sanofi Pasteur to regain all rights to KaloBios\' KB001-A program. Under this agreement, the collaboration and licensing agreement entered into in 2010 has been terminated. Under that collaboration agreement, Sanofi Pasteur had been developing KB001A, a patented monoclonal antibody targeting Pseudomonas aeruginosa (Pa), for Pa pneumonia prevention in the intensive care setting while KaloBios had been developing KB001A for chronic treatment of Pa lung infections in cystic fibrosis (CF) patients. KaloBios also announced that it has achieved full enrollment in the 180 patient Phase 2 study evaluating KB001A in CF subjects with chronic Pa lung infection. KaloBios now expects to release top-line data on this study in early first quarter 2015. KaloBios had previously completed a Phase 1/2 study with KB001 in thirty-five patients colonized with Pa which demonstrated approximately a 50% reduction in ventilator associated pneumonia (VAP) in patients treated with KB001. The study also showed a dose-dependent increase in bacterial event-free survival relative to placebo. The results of this study were published in Critical Care Medicine, and represented the primary efficacy data included in the Sanofi Pasteur regulatory submission under which the VAP indication received Fast Track Status from the FDA. In a separate Phase 1/2 study conducted with CF patients, KaloBios showed a trend towards a dose-dependent reduction in several key inflammatory markers, including neutrophil elastase, when measured 28 days after a single dose of KB001. The results of this study were published in Pediatric Pulmonology. KaloBios is currently conducting a 180 patient Phase 2 study of KB001A in CF subjects with chronic Pa lung infection. KaloBios has received Orphan Drug designation from both the FDA and the European Medicines Agency for KB001A for the treatment of Pa lung infection in CF patients. KB001A has also received Fast Track Status from the FDA for the prevention of ventilator associated pneumonia. KaloBios is planning to seek a partner to help accelerate the development of this program.
Financial terms: Sanofi Pasteur agreed to terminate the collaboration and licensing agreement with KaloBios in consideration of low single digit royalties on net sales of KB001-A, subject to a $40 million cap on the aggregate royalties to be paid. In addition, Sanofi Pasteur will be entitled to receive up to 10% of certain sub-license payments or other milestone payments received in the event KaloBios successfully re-partners KB001-A, subject to a separate $40 million cap on the aggregate amount of sub-license payments to be shared with Sanofi Pasteur.
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