Humanigen has finished enrolling patients in its ongoing Phase I trial of lenzilumab in patients with previously treated chronic myelomonocytic leukaemia (CMML).
The trial seeks to examine the maximum tolerated dose, safety and efficacy of single-agent lenzilumab in 12 patients with CMML who are relapsed, refractory to, or intolerant to standard-of-care treatments.
It also intends to provide additional data on pharmacokinetics and pharmacodynamics.
Humanigen chairman and CEO Cameron Durrant said: “Full enrollment of the CMML trial shows our unflinching commitment to execution on the important work to progress our assets, strengthen our company and to drive value for patients and all our stakeholders.
“We look forward to more milestones quickly ahead as we compile an interim report on the safety of lenzilumab in CMML and we initiate a planned Phase Ib/II study to assess lenzilumab’s potential to prevent and/or reduce neurotoxicity related to CAR-T cancer therapy.”
Lenzilumab is a new Humaneered recombinant monoclonal antibody developed to target and neutralise circulating granulocyte-macrophage colony-stimulating factor (GM-CSF), a central actor in leukocyte differentiation, autoimmunity and inflammation.
Lenzilumab is also a potent inhibitor of GM-CSF in vivo.
In previous clinical studies, lenzilumab has been demonstrated as safe and well-tolerated in more than 100 patients, including those with rheumatoid arthritis, asthma and healthy volunteers.