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news.KaloBios Pharmaceuticals has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for KB003, an anti-GM-CSF monoclonal antibody (mAb), to treat patients with chronic myelomonocytic leukemia (CMML).
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The IND acceptance allows the company to start an open-label Phase I trial designed to evaluate the safety, pharmacokinetics and clinical activity of KB003 in previously treated CMML patients.
The trial will include an accelerated dose escalation component starting at 200mg and escalating up to 600mg, followed by a group expansion of up to 13 additional patients to explore clinical activity at the selected dose level.
The company noted that site initiation activities are underway and patient enrollment is expected to begin later this year.
H. Lee Moffitt Cancer Center and Research Institute Department of Hematologic Malignancies Dr Eric Padron said: "I am very excited to be able to explore KB003, an anti-GM-CSF agent, as a potential therapeutic for CMML patients given the significant unmet medical need these patients face.
"Given the hyper-sensitivity of CMML cells to GM-CSF, and the cell killing we have seen in our pre-clinical work as a result of depriving CMML cells of GM-CSF using KB003, we are hopeful that KB003 will prove to be an effective therapeutic for patients suffering from CMML."
KaloBios is focused on improving the lives of patients by developing new therapies to treat diseases of high unmet medical need, with a focus on oncology.