KaloBios Pharmaceuticals Inc (NASDAQ:KBIO), a monoclonal antibody company focused on developing innovative therapies to benefit patients with diseases of unmet medical need, with a focus on oncology, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for KB003, an anti-GM-CSF monoclonal antibody (mAb), in patients with chronic myelomonocytic leukemia (CMML), and that the IND is now active.

The acceptance of this IND allows KaloBios to initiate an open-label Phase I study designed to evaluate the safety, pharmacokinetics and clinical activity of KB003 in previously treated CMML patients. The study will consist of an accelerated dose escalation component starting at 200 mg and escalating up to 600 mg, followed by a cohort expansion of up to 13 additional patients to explore clinical activity at the selected dose level. Site initiation activities are underway, and the company anticipates that enrollment will begin later this year.

“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,” said Dr. Eric Padron of the Department of Hematologic Malignancies at H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida. “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.”

CMML is a life-threatening hematologic malignancy characterized by elevated levels of monocytes, immature blood cells, or blast cells, and abnormal cells in the peripheral blood as well as in the bone marrow.  According to the American Cancer Society, there are approximately 1,100 new diagnoses of CMML each year in the United States and median survival from diagnosis is 15 to 20 months. Current approved treatment options for CMML patients are limited and generally consist of hypomethylating agents or hydroxyurea. (Original Source)

Shares of KaloBios Pharmaceuticals Inc opened today at $2.32 and are currently trading up at $2.35. KBIO has a 1-year high of $17.20 and a 1-year low of $2.18. The stock’s 50-day moving average is $3.62 and its 200-day moving average is $3.96.

KaloBios Pharmaceuticals Inc is a biopharmaceutical company. The Company is engaged in the development of monoclonal antibody therapeutics for diseases that burdens the society and to patients and their families.