Coronado Biosciences Inc., a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, has received orphan-drug designation from US Food and Drug Administration (FDA) for CNDO-109-Activated Allogeneic Natural Killer Cells (CNDO- 109) for “the treatment of acute myeloid leukemia (AML).”

CNDO-109 is a biologic that activates the immune system’s natural killer cells to seek and destroy cancer cells. Preclinical studies of CNDO-109 have demonstrated activity in multiple myeloma, breast cancer, prostate cancer and ovarian cancer and, based on data obtained from a phase I investigator- sponsored clinical trial in patients with AML, the company believes early efficacy was observed.

Coronado currently plans to initiate a phase I/II dose escalation trial in AML patients in the second half of 2012.

Orphan-drug designation is granted by the US FDA Office of Orphan Products Development to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the US. The designation provides the drug developer with a seven-year period of US marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication. It also provides tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.