Emergent BioSolutions and Humanigen have signed a contract development and manufacturing (CDMO) services agreement to accelerate the manufacturing of the drug lenzilumab.
Lenzilumab is an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to prevent and treat an immune hyper-response called “cytokine storm.” Cytokines are immune system proteins but cytokines storms happen when these proteins attack cells rather than the virus. They happen in autoimmune diseases and cancer and are often triggered by the flu or recently, COVID-19.
Lenzilumab is currently in a Phase 3 clinical trial evaluating patients hospitalized with COVID-19. Humanigen plans to file for emergency use authorization (EUA) in the first quarter of 2021.
Emergent will provide access to manufacturing capacity provided by the U.S. government under Humanigen’s Cooperative Research and Development Agreement (CRADA) with the Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Biomedical Advanced Research and Development Authority (BARDA).
Under the terms of the agreement, Emergent will provide CDMO services for the manufacturing of drug product batches to support Humanigen’s efforts to increase supply of lenzilumab in anticipation of a the potential EUA in first quarter of 2021. Emergent would utilize its Baltimore drug product manufacturing facility. This expanded facility was built to provide increased capacity and flexibility to support companies in need of clinical and commercial manufacturing capabilities. The parties intend to negotiate a commercial manufacturing services agreement that could include future fill batches for a biologics license application (BLA).
“As we continue to advance lenzilumab for patients hospitalized with COVID-19, we are executing on plans to ensure that we have the necessary support for the next phase of our growth. Partnering with leading CDMOs like Emergent BioSolutions to help us build out our manufacturing capacity is a cornerstone to that strategy,” Cameron Durrant, chief executive officer of Humanigen, said. “The impact of BARDA’s support through our CRADA and its public-private CDMO partnership with Emergent is vital to our progress and bringing innovative solutions for patients with COVID-19.”
For Emergent, this agreement follows the landmark public-private CDMO partnership between Emergent and BARDA, announced in June 2020. The agreement paved the way for high-priority innovators leveraging reserved capacity at their Drug Substance and Drug Product facilities.
“Drug product manufacturing is a hallmark capability of our CDMO services, and we stand ready to harness our expertise to advance lenzilumab, Humanigen’s COVID-19 therapeutic candidate,” Syed T. Husain, senior vice president and CDMO business unit head at Emergent BioSolutions, said. “Every second counts in the fight against COVID-19, and we are proud that Humanigen trusts us to rapidly deploy our clinical-to-commercial manufacturing operations to fulfill the urgent need for COVID-19 therapeutic options.”
This latest deal is Emergent’s seventh CDMO collaboration with government and industry partners working to deliver COVID-19 vaccine and therapeutic solutions.