Humanigen has announced an expansion to the Cooperative Research and Development Agreement (CRADA) with the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).
Through the expanded agreement, Humanigen will now gain access to manufacturing capacity reserved by the Biomedical Advanced Research and Development Authority (BARDA) for the development of lenzilumab as a potential treatment for Covid-19.
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services.
With the agreement now in hand, Humanigen can access the manufacturing capacity for fill-finish product to speed up the production of lenzilumab.
Initially, the company had signed the agreement in November last year, acquiring access to a full-scale, integrated team of manufacturing and regulatory subject matter experts and statistical support in anticipation of applying for EUA and subsequently a Biologics License Application (BLA) for lenzilumab as a potential treatment for Covid-19.
Humanigen CEO Cameron Durrant said: “It has been an honour to have the integrated expert team at BARDA prioritise lenzilumab research and development during this critical time.
“As we move closer to filing a potential EUA, the integrated support of BARDA and JPEO helps us with manufacturing capabilities as we ready operations to support access to lenzilumab.”
Presently, lenzilumab is in Phase 3 clinical trials, evaluating patients with Covid-19. The enrolling was completed last November. The drug is based on Humanigen’s patented Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody.
It is claimed to have been designed to prevent and treat an immune hyper-response called cytokine storm, a complication that is considered to be a cause of death in Covid-19 patients.
Data suggests that up to 89% of hospitalised Covid-19 patients are at risk of immune hyper-response, which can trigger acute respiratory distress syndrome in severe cases.