News & Events

KB004, experimental anti-EphA3 monoclonal antibody therapeutic, in clinical development against hematologic cancers

SOUTH SAN FRANCISCO, CA (December 5, 2013): KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO), today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for a composition of matter patent covering certain antibodies targeting EphA3, including KaloBios’ experimental anti-cancer monoclonal antibody (mAb), KB004.  The allowed claims relate to high-affinity Humaneered^® antibodies to the EphA3 receptor.

Geoffrey Yarranton, Ph.D., KaloBios’ Chief Scientific Officer and co-inventor, commented, “EphA3 is a tyrosine kinase receptor that is expressed on hematologic cancers and solid tumors, including tumor stem cells, but not on normal blood or bone marrow stem cells. Targeting this antibody may therefore offer a way to selectively treat patients with hematologic malignancies who have become resistant or otherwise intolerant of standard chemotherapies.”

KaloBios is currently conducting a Phase 1 study of KB004 in hematologic malignancies and will be presenting interim data from that study at the 55^th American Society of Hematology Annual Meeting and Exhibition on December 9, 2013.  The Phase 1 study of KB004 is a multi-center, dose-escalation study evaluating KB004 in patients with advanced hematologic malignancies.  KaloBios plans to initiate the Phase 2 portion of the study in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients by the end of the year.

“This Notice of Allowance is a validation of the uniqueness of KB004 and our Humaneered^® technology incorporated into it.  This is the third significant composition of matter patent for our proprietary product candidates, following U.S. patents granted for KB001-A and KB003, all expiring in 2028 and beyond,” said Don Joseph, KaloBios’ Chief Legal Officer.

About KaloBios

KaloBios Pharmaceuticals, Inc. is developing a portfolio of proprietary, patient-targeted, first-in-class monoclonal antibodies designed to treat severe life-threatening or debilitating diseases for which there is an unmet medical need, with a clinical focus on severe respiratory diseases and cancer.

Currently, KaloBios has three drug development programs:

·        KB003, an anti-GM-CSF mAb with potential to treat inflammatory diseases, being developed for the treatment of severe asthma. Enrollment of 160 patients has been completed in a Phase 2 study in the United States, Europe and Australia.

·        KB001-A, an anti-PcrV mAb fragment, 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 is conducting a 180 patient Phase 2 study in CF subjects with chronic Pa lung infection in the United States.  KaloBios has received Orphan Drug designation from both the U.S. FDA and the European Medicines Agency for KB001-A for the treatment of Pa lung infection in CF patients. Sanofi is pursuing a ventilator-associated pneumonia prevention indication in the intensive care setting, an indication which has received U.S. FDA Fast Track Designation.

·        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.

For more information on KaloBios Pharmaceuticals, please visit our web site at http://www.kalobios.com.