KaloBios Provides Update on Pipeline of Clinical Programs

Jun 27, 2013, 08:00 ET from KaloBios Pharmaceuticals

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.

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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."

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, is being developed for the treatment of severe asthma. Enrollment of 160 patients has been completed in a planned 150 patient Phase 2 study in the United States, Europe and Australia.
  • KB001-A, an anti-PcrV mAb fragment, is partnered exclusively with Sanofi and is being developed for the prevention and treatment of Pa infection. KaloBios has retained rights for the CF indication and has initiated a 180 patient Phase 2 study in CF subjects with chronic Pa lung infection in the United States. 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.

Forward Looking Statements This release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including: the statements under the heading "Anticipated Upcoming Milestones for 2013-2014"; and statements regarding the company's clinical development of KB001-A, KB003 and KB004. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the company's limited cash reserves and its ability to obtain additional capital on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that the company has initiated or plans to initiate; the company's dependence on Sanofi Pasteur for the development and commercialization of KB001-A; the company's ability to successfully complete further development of its programs; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; the company's ability to protect the company's intellectual property; competition; changes in the regulatory landscape or the imposition of regulations that affect the company's products; and other factors listed under "Risk Factors" in the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 1, 2013 and the company's other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The company has no obligation, and expressly disclaims any obligation to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.


Jeffrey H. Cooper Chief Financial Officer KaloBios Pharmaceuticals, Inc. (650) 243-3146 ir@kalobios.com

Media Contact:

Joan E. Kureczka Kureczka/Martin Associates Tel: (415) 821-2413 Mobile: (415) 690-0210 Joan@Kureczka-Martin.com

SOURCE KaloBios Pharmaceuticals