PHASE I LENZILUMAB STUDY UNDERWAY IN CMML PATIENTS.
Lenzilumab is a highly potent GM-CSF antagonist with a favorable safety profile. It has been tested in more than 90 patients and found to be well tolerated in previous clinical studies in either healthy adults or those with autoimmune diseases.
GM-CSF is one of the cytokines involved in the development and maturation of certain types of myeloid blood cells. Earlier data generated by a collaborator confirmed that hypersensitivity to GM-CSF plays an important role in the growth and survival of CMML cells. Such hypersensitivity is also a hallmark of JMML. Inhibition of GM-CSF may affect growth of leukemic cells in patients.
Currently available treatments in CMML are limited and produce inadequate responses, leaving these patients with high unmet medical need for effective and tolerable therapies.
KaloBios has started a Phase I trial focused on patients with previously treated CMML. The Phase I study is a multi-center, open-label dose escalation trial to evaluate the safety, maximum tolerated dose and preliminary activity of single-agent lenzilumab in CMML patients who are relapsed, refractory to, or intolerant to standard-of-care treatments. The first patient was dosed with lenzilumab in late July 2016.
The study will enroll up to 18 patients and is designed to identify the maximum tolerated dose –and a recommended Phase II dose – of lenzilumab in previously treated CMML patients. It will also assess preliminary efficacy of single-agent lenzilumab and provide additional data on pharmacokinetics, pharmacodynamics – including correlative biomarkers and mutational analysis – and safety.