BARDA will provide technical assistance on a Phase 3 clinical trial underway to evaluate the use of a drug, lenzilumab™, being developed by Humanigen, Inc., to prevent or treat an immune hyper-response called a cytokine storm.
Through a Cooperative Research and Development Agreement (CRADA) with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), BARDA will provide Humanigen subject matter expertise for statistical analysis, and manufacturing and regulatory activities to support drug development in advance of a potential Emergency Use Authorization (EUA) for COVID-19. Cytokine storm is a severe immune reaction in which the body releases a high level of cytokines in the blood in a short time frame, which can result in lung injury, and is associated with COVID-19 infections. Cytokine storm can also be triggered by the acute respiratory distress syndrome in severe cases of COVID-19. Lenzilumab is being evaluated as a treatment for cytokine storm, which may help prevent lung damage.
Lenzilumab is Humanigen's proprietary Humaneered® monoclonal antibody directed against granulocyte macrophage-colony stimulating factor (GM-CSF). GM-CSF is a cytokine secreted by immune cells, and high levels of it correlate with disease severity, cytokine storm, and respiratory failure in COVID-19 patients. A Phase 3 registration trial is ongoing at 18 approved clinical trial sites in the U.S. In addition, lenzilumab was selected by the National Institutes of Health (NIH) for its ACTIV-5 “Big Effect Trial.”
Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) is a public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of some of the most promising treatments and vaccines to treat or prevent SARS-COV-2 infections.
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
Humanigen, Inc. is a clinical-stage biopharmaceutical company developing its portfolio of next-generation cell and gene therapies for the treatment of cancers via its novel, GM-CSF neutralization and gene-knockout platforms. As a leader in GM-CSF pathway science, they are trying to transform CAR-T therapy and a broad range of other T-cell engaging therapies, including both autologous and allogeneic cell transplantation.