Clinical-stage biopharmaceutical company Humanigen and EVERSANA have entered a partnership to make available the former’s lead drug candidate, lenzilumab, to hospitalised and hypoxic Covid-19 patients on obtaining approval.
The company is anticipating an Emergency Use Authorisation issued by the US Food and Drug Administration (FDA) as well as a BLA.
Lenzilumab is a humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody that can potentially prevent and treat cytokine storm, which can lead to acute respiratory distress syndrome in severe cases.
Humanigen CEO Cameron Durrant said: “EVERSANA shares our tireless commitment to patients.
“We’ve matched our dedication to research and development in Covid-19 with a proven commercialisation partner to ensure lenzilumab will reach patients quickly and efficiently following a potential EUA.”
Estimates show that up to 89% of hospitalised Covid-19 patients are hypoxic and at risk of cytokine storm.
According to the deal, with a EUA for lenzilumab for treating hospitalised Covid-19 patients expected, Humanigen will have urgent access to EVERSANA’s fully integrated services optimised by data and predictive analytics.
EVERSANA CEO Jim Lang said: “We stand ready to immediately activate our services spanning all disciplines of the product journey to ensure lenzilumab delivers significant patient value.
“While EVERSANA’s model can be applied to any therapy or indication, we have a moral obligation to help Covid-19 patients in distress, knowing that even with the promise of vaccines there will be many patients who contract this virus and desperately need a treatment if hospitalised and hypoxic.”
Last November, Humanigen signed an agreement with the US Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to develop lenzilumab for Covid-19 treatment.