Coronado Biosciences Inc., a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for CNDO-109, a novel biologic that primes natural killer (NK) cells without the need for cytokines (IL-2), and is being studied for the treatment of patients with high risk acute myeloid leukaemia (AML) in first complete remission.

“The submission of the IND marks an important milestone in the development of our NK cell programme,” said Dr Bobby W Sandage, Jr., Coronado’s president and CEO. “We are extremely encouraged by the data generated to date on CNDO-109.  Pending FDA review of our IND, we anticipate initiating a phase I/II allogeneic clinical trial for the treatment of patients with high risk AML in first complete remission in the second quarter of this year.”

Results from a phase I investigator-initiated clinical trial of CNDO-109 were presented at the 53rd American Society of Hematology (ASH) Annual Meeting and Exposition on December 13, 2011. Although the primary endpoint of the phase I clinical trial was safety, the results demonstrated that the majority of AML patients experienced a longer complete remission (CR) after receiving CNDO-109 activated NK cells than their previous complete remission.

AML is one of the most deadly and most common types of acute leukaemia in adults. There are over 30,000 cases worldwide, primarily afflicting elderly and relapsed and refractory populations. Once diagnosed with AML, patients typically receive induction and consolidation chemotherapy, with the majority achieving complete remission.

CNDO-109 is a novel biologic that primes natural killer (NK) cells without the need for cytokine (IL-2) treatment that is being evaluated for the treatment of hematological cancers, including AML, and solid tumours. CNDO-109 activated NK cells have shown early efficacy in an investigator-initiated phase I clinical trial in patients with AML and demonstrated preclinical activity in multiple myeloma, breast cancer, prostate cancer and ovarian cancer.