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KaloBios Provides Update On Pipeline Of Clinical Programs

SOUTH SAN FRANCISCO, Calif., June 27, 2013 /PRNewswire/ -- KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO) today provided an update on the status of its ongoing clinical programs for KB003, KB001-A and KB004, its pipeline of proprietary monoclonal antibodies in development for severe respiratory diseases and cancer.

(Logo: http://photos.prnewswire.com/prnh/20130225/MM66380LOGO)

The company announced early completion of enrollment in its ongoing Phase 2 study of KB003, a Humaneered ® monoclonal antibody (mAb) targeting granulocyte macrophage colony-stimulating factor (GM-CSF) in subjects with severe asthma whose disease is not adequately controlled by corticosteroids.

KaloBios also reported that enrollment has been slower than planned on its ongoing Phase 2 study of KB001-A, a Humaneered ® mAb being studied in patients with cystic fibrosis (CF) who are chronically infected with Pseudomonas aeruginosa ( Pa). KB001-A, an anti-PcrV mAb fragment, is a novel, anti-infective approach to the treatment of chronic Pa infections that cause airway inflammation and irreversible lung damage in patients with CF. 

In its third program, focused on cancer, KaloBios has also progressed its Phase 1 dose escalation safety study for KB004 without yet reaching dose-limiting toxicities.  KB004 is KaloBios' Humaneered ® mAb targeting the EphA3 receptor tyrosine kinase, an antigen expressed in a number of hematologic and solid tumor cells. 

"Full recruitment of our clinical proof-of-concept study for KB003 in patients with severe asthma, conducted in the United States, Europe and Australia, has been achieved ahead of schedule," said Néstor A. Molfino, M.D., Chief Medical Officer of KaloBios. "We now look forward to announcing top line data early in the first quarter of 2014 and presenting detailed results at a major scientific meeting next year."

"Enrollment in our CF trial of KB001-A has been slower than planned," Dr. Molfino added. "We believe that this delay may be due to a number of reasons, including other CF trials underway in the United States. Based on our revised projections, we are now targeting release of top line data from this KB001-A study in the fourth quarter of 2014."

"Finally, we are pleased to announce that we have progressed to the 190 mg cohort in our KB004 (anti-EphA3) dose escalation trial in hematologic malignancies, the sixth dose level being tested," Dr. Molfino continued. "We continue to plan for the expansion phase of this study treating EphA3 positive acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients.  We are targeting this study to begin in the third quarter of this year."

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