On July 25, 2016 KaloBios Pharmaceuticals, Inc. (OTC:KBIO), a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases, reported that the first patient has been dosed in its open-label, multi-center Phase 1 clinical trial with lenzilumab (formerly KB003) focused on patients with previously-treated Chronic Myelomonocytic Leukemia (CMML) (Press release, KaloBios, JUL 25, 2016, View Source [SID:1234514144]).
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This multi-center Phase 1 dose escalation trial is being conducted to evaluate the safety, maximum tolerated dose, and preliminary activity of single-agent lenzilumab in subjects with CMML who are relapsed/refractory to, and/or intolerant to, standard-of-care treatments.
"The new KaloBios is now in action mode, and the first dosing of a patient in the lenzilumab study highlights our pivot to swift execution in advancing our pipeline assets," said Cameron Durrant, MD, KaloBios chairman and CEO. "CMML is a rare and devastating disease for which there are limited effective treatment options currently available. We anticipate this trial will demonstrate lenzilumab’s potential to help patients who need new treatment options and support its continued clinical advancement."
The study will enroll up to 18 patients and is designed to identify the maximum tolerated dose, or recommended Phase 2 dose, of lenzilumab in subjects with previously-treated CMML. It will also assess preliminary efficacy of single-agent lenzilumab and to provide additional data on pharmacokinetics, pharmacodynamics and safety.
"The first patient to receive treatment in this study also signifies the first of many important clinical milestones ahead for KaloBios, as we seek to tackle neglected and rare diseases through innovative and responsible business models," added Dr. Durrant.
About Lenzilumab
Lenzilumab is a monoclonal antibody that targets and is an antagonist of soluble Granulocyte Macrophage – Colony Stimulating Factor (GM-CSF), a cytokine suggested to be central to the inflammation and activation of certain immune cells. Lenzilumab has been studied for its ability to limit hypersensitivity to GM-CSF signaling, which appears to be a key feature to many CMML patients and its inhibition may affect the growth of leukemic cells in patients. Lenzilumab has been tested in more than 90 subjects in previous clinical trials in rheumatoid arthritis, asthma and healthy volunteers, and was found to be well tolerated. Data also suggest lenzilumab may have the potential to treat other diseases, including juvenile myelomonocytic leukemia (JMML).
About CMML
CMML is a rare and aggressive cancer of the blood with approximately 1,500-3,000 new cases per year in the United States. The cancer interferes with normal blood cell production, including red blood cells, white blood cells and platelets. CMML patients have shortened life expectancies, with a median survival rate of one to two years, and approximately 15-30 percent of patients will go on to develop acute leukemia.