KB003 is a Humaneered, recombinant monoclonal antibody (mAb) that neutralizes soluble granulocyte-macrophage colony-stimulating factor (GM-CSF), a critical cytokine for the growth of certain hematologic malignancies and solid tumors (Company Pipeline, KaloBios, JUL 4, 2016, View Source [SID:1234513679]).

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KB003 is a highly potent GM-CSF antagonist with a favorable safety profile that has previously been studied in more than 90 subjects in clinical studies in either healthy adults or adults with autoimmune diseases.

Data generated by a collaborator of the company confirm GM-CSF hypersensitivity plays an important role in inappropriate growth and survival of CMML cells, similar to juvenile myelomonocytic leukemia (JMML), in which such hypersensitivity is a hallmark of the disease.

This data also strongly suggests a role for KB003 in the treatment of CMML. Because KaloBios is now focused on oncology indications for KB003, and following discussions with clinical experts, the Food and Drug Administration, and the European Medicines Agency, the company intends to initiate study enrollment in a Phase 1 clinical trial in CMML patients to assess the safety, pharmacokinetics, and activity of KB003 in this patient population later this year.