SOUTH SAN FRANCISCO, CA, USA I September 11, 2012 I KaloBios Pharmaceuticals, Inc. today announced that dosing has begun in a randomized, double-blind, placebo-controlled Phase 2 clinical trial of KB003, the company’s anti-GM-CSF Humaneered™ monoclonal antibody, in subjects with severe asthma uncontrolled by corticosteroids.
“KB003 is a potent inhibitor of GM-CSF, a cytokine thought to be central to the inflammatory response that activates immune cells believed to play a key role in the two main phenotypes of asthma, allergic and non-allergic”
The multi-center study will enroll approximately 150 subjects at sites throughout the United States, Europe and Australia. Subjects will be dosed with KB003 or placebo in addition to current therapy for 5 months. The primary endpoint for the study is the change in mean pre-bronchodilator forced expiratory volume (FEV1) from baseline, a marker of airway obstruction. Secondary endpoints include asthma exacerbation rate and the degree of asthma symptom control. KaloBios expects to complete the study in Q1 2014.
“KB003 is a potent inhibitor of GM-CSF, a cytokine thought to be central to the inflammatory response that activates immune cells believed to play a key role in the two main phenotypes of asthma, allergic and non-allergic,” said Néstor A. Molfino, M.D., KaloBios’ Chief Medical Officer. “Results of a previous Phase 1/2 study showed this antibody to be well tolerated and non-immunogenic. We now look forward to evaluating the therapeutic potential of KB003 in a severe asthma patient population in a randomized, placebo-controlled trial with repeat dosing.”
“This clinical study is an example of our strategy of enriching patient selection for response to our therapeutic agents (patient targeted antibody therapy),” said David Pritchard, KaloBios’ Chief Executive Officer. “We hope to expand upon the activity of our anti-GM-CSF antibody seen in our previous clinical study.”
“We are targeting the severe asthma population which represents approximately 5 – 10% of the total asthma population of more than 300 million people. Severe asthma is responsible for approximately 50% of asthma hospitalization costs,” noted Mr. Pritchard.
About KaloBios
KaloBios Pharmaceuticals, Inc. is developing a portfolio of proprietary, patient-targeted, first-in-class monoclonal antibodies (mAbs) designed to significantly improve the lives of seriously ill patients with difficult-to-treat diseases.
Currently, KaloBios has three drug development programs:
KB001-A, an anti-PcrV mAb fragment, is partnered exclusively with Sanofi Pasteur and is being developed for the prevention and treatment of Pseudomonas aeruginosa (Pa) infection. KaloBios has retained rights for the cystic fibrosis (CF) indication and plans to initiate a Phase 2 study in CF subjects with chronic Pa infection.
KB003, an anti-GM-CSF mAb with potential to treat inflammatory diseases, is being developed for the treatment of severe asthma.
KB004, an anti-EphA3 mAb, has potential in treating hematologic malignancies and solid tumors. KaloBios is currently testing this drug in a Phase 1 study in subjects with hematologic malignancies.
All of the company’s antibodies were generated using its proprietary Humaneered™ technology, a method that converts nonhuman antibodies (typically mouse) into recombinant antibodies that have a high binding affinity to their target and are designed for chronic therapeutic use. The company believes that antibodies produced using its Humaneered™ technology offer important clinical and economic advantages over antibodies generated by other methods in terms of high binding affinity, high manufacturing yields, and minimal to no immunogenicity (inappropriate immune response) upon repeat administration in humans.
SOURCE: KaloBios Pharmaceuticals
Post Views: 64
SOUTH SAN FRANCISCO, CA, USA I September 11, 2012 I KaloBios Pharmaceuticals, Inc. today announced that dosing has begun in a randomized, double-blind, placebo-controlled Phase 2 clinical trial of KB003, the company’s anti-GM-CSF Humaneered™ monoclonal antibody, in subjects with severe asthma uncontrolled by corticosteroids.
“KB003 is a potent inhibitor of GM-CSF, a cytokine thought to be central to the inflammatory response that activates immune cells believed to play a key role in the two main phenotypes of asthma, allergic and non-allergic”
The multi-center study will enroll approximately 150 subjects at sites throughout the United States, Europe and Australia. Subjects will be dosed with KB003 or placebo in addition to current therapy for 5 months. The primary endpoint for the study is the change in mean pre-bronchodilator forced expiratory volume (FEV1) from baseline, a marker of airway obstruction. Secondary endpoints include asthma exacerbation rate and the degree of asthma symptom control. KaloBios expects to complete the study in Q1 2014.
“KB003 is a potent inhibitor of GM-CSF, a cytokine thought to be central to the inflammatory response that activates immune cells believed to play a key role in the two main phenotypes of asthma, allergic and non-allergic,” said Néstor A. Molfino, M.D., KaloBios’ Chief Medical Officer. “Results of a previous Phase 1/2 study showed this antibody to be well tolerated and non-immunogenic. We now look forward to evaluating the therapeutic potential of KB003 in a severe asthma patient population in a randomized, placebo-controlled trial with repeat dosing.”
“This clinical study is an example of our strategy of enriching patient selection for response to our therapeutic agents (patient targeted antibody therapy),” said David Pritchard, KaloBios’ Chief Executive Officer. “We hope to expand upon the activity of our anti-GM-CSF antibody seen in our previous clinical study.”
“We are targeting the severe asthma population which represents approximately 5 – 10% of the total asthma population of more than 300 million people. Severe asthma is responsible for approximately 50% of asthma hospitalization costs,” noted Mr. Pritchard.
About KaloBios
KaloBios Pharmaceuticals, Inc. is developing a portfolio of proprietary, patient-targeted, first-in-class monoclonal antibodies (mAbs) designed to significantly improve the lives of seriously ill patients with difficult-to-treat diseases.
Currently, KaloBios has three drug development programs:
KB001-A, an anti-PcrV mAb fragment, is partnered exclusively with Sanofi Pasteur and is being developed for the prevention and treatment of Pseudomonas aeruginosa (Pa) infection. KaloBios has retained rights for the cystic fibrosis (CF) indication and plans to initiate a Phase 2 study in CF subjects with chronic Pa infection.
KB003, an anti-GM-CSF mAb with potential to treat inflammatory diseases, is being developed for the treatment of severe asthma.
KB004, an anti-EphA3 mAb, has potential in treating hematologic malignancies and solid tumors. KaloBios is currently testing this drug in a Phase 1 study in subjects with hematologic malignancies.
All of the company’s antibodies were generated using its proprietary Humaneered™ technology, a method that converts nonhuman antibodies (typically mouse) into recombinant antibodies that have a high binding affinity to their target and are designed for chronic therapeutic use. The company believes that antibodies produced using its Humaneered™ technology offer important clinical and economic advantages over antibodies generated by other methods in terms of high binding affinity, high manufacturing yields, and minimal to no immunogenicity (inappropriate immune response) upon repeat administration in humans.
SOURCE: KaloBios Pharmaceuticals
Post Views: 64
