SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--KaloBios Pharmaceuticals, Inc. today announced an agreement with Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, for the development and commercialization of KB001, an investigational new biologic for the treatment or prevention of Pseudomonas aeruginosa (Pa) infections. Sanofi Pasteur will be responsible for the development and commercialization of KB001 and initially focus on hospital indications, including the prevention of Pa pneumonias in mechanically ventilated patients. KaloBios will focus on developing and commercializing KB001 for use in treating patients with cystic fibrosis and bronchiectasis, an obstructive lung disease aggravated by bacterial infections.
Under the terms of the agreement, KaloBios will receive an upfront payment of $35 million from Sanofi Pasteur, plus development, regulatory and commercial milestones for a potential further $255 million, as well as royalties on eventual product sales. Sanofi Pasteur also has the option to acquire commercial rights to KaloBios’ indications for KB001 outside the United States and co-promotion rights in the United States.
“Sanofi Pasteur is the world’s largest company devoted entirely to human vaccines, including those for the prevention of pneumonia,” said David Pritchard, President and Chief Executive Officer of KaloBios. “Their enormous development expertise in the field of infectious disease and worldwide commercialization capabilities make them the ideal partner for KB001, which has shown early promise in preventing Pa pneumonia and mortality in mechanically ventilated patients and in treating patients with cystic fibrosis.”
“Hospital-based pneumonias, especially those associated with mechanically ventilated patients in the ICU, are a life-threatening complication that can significantly increase mortality and morbidity as well as add tens of thousands of dollars to the cost of a hospital stay,” said Tillman Pearce, M.D., Chief Medical Officer of KaloBios. “KB001’s novel mechanism of action against Pa provides a unique means of fighting these infections, which are often resistant to antibiotic therapies. We also think this novel mechanism could have a significant impact on Pseudomonas aeruginosa infections in cystic fibrosis patients as well.”
KB001, 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, KB001 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. KB001 avoids known mechanisms of antibiotic resistance and does not contribute to broad-spectrum resistance, making it optimal for use as a single agent or in synergy with antibiotics in the preventive or therapeutic setting. KB001 has completed two Phase 1/2 clinical studies in mechanically ventilated patients colonized with Pa and in chronically Pa infected patients with cystic fibrosis.
KaloBios Pharmaceuticals, Inc., a U.S. based, private monoclonal company, uses its biologic capabilities and its proprietary platform technology to develop first-in-class human antibody therapeutics. The company has multiple programs that have been in seven Phase 1 or 2 clinical trials in the last few years. KB001 is a PEGylated monoclonal antibody fragment directed against Pseudomonas aeruginosa that is in development for patients with cystic fibrosis and patients in intensive care on a ventilator. KaloBios is also developing an anti-GM-CSF human monoclonal (KB003) for the treatment of patients with autoimmune and chronic inflammatory conditions, such as rheumatoid arthritis and asthma. KB004 is a human monoclonal antibody in preclinical development for hematologic malignancies and solid tumors. The company’s Humaneering™ technology is designed to offer advantages over other methods of human antibody creation in terms of immunogenicity, potency, and manufacturing yields. For more information, visit http://www.kalobios.com.