KaloBios Pharmaceuticals has updated 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.
It announced early completion of enrollment in its ongoing phase II study of KB003, a Humaneered monoclonal antibody (mAb) targeting granulocyte macrophage colony-stimulating factor (GM-CSF) in patients with severe asthma whose disease is not adequately controlled by corticosteroids.
KaloBios also reported enrollment has been slower than planned on its ongoing phase II 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.
"Enrollment in our CF trial of KB001-A has been slower than planned," said Néstor A. Molfino, M.D., chief medical officer of KaloBios. "We believe that this delay may be due to reasons including other CF trials underway in the U.S. 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."
In its third program, focused on cancer, KaloBios has also progressed its phase I, 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.
"We have progressed to the 190mg cohort in our KB004 (anti-EphA3) dose-escalation trial in hematologic malignancies, the sixth dose level being tested," said Molfino. "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."