Tim Wright, Editor, Contract Pharma01.25.21
Emergent BioSolutions and Humanigen have entered into a contract development and manufacturing (CDMO) services agreement to accelerate the drug product manufacturing of lenzilumab, an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to prevent and treat an immune hyper-response called “cytokine storm.”
Emergent will provide access to manufacturing capacity reserved for and 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), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services. Lenzilumab is currently in a Phase 3 clinical trial evaluating patients hospitalized with COVID-19. Humanigen intends to file for emergency use authorization (EUA) in the first quarter of 2021.
Under the terms of the agreement, Emergent will provide its integrated CDMO services for the manufacturing of drug product batches to support Humanigen’s efforts to increase supply of lenzilumab in anticipation of a potential EUA beginning in the first quarter of 2021, including utilization of a new state-of-the-art flex fill line at Emergent’s Baltimore, MD (Camden) drug product manufacturing facility. This newly 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,” said Cameron Durrant, chief executive officer, Humanigen. “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 and is in addition to the landmark public-private CDMO partnership between Emergent and BARDA, announced in June 2020, to pave 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,” said Syed T. Husain, senior vice president and CDMO business unit head, Emergent BioSolutions. “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 agreement marks Emergent’s seventh CDMO collaboration with government and industry partners working to deliver COVID-19 vaccine and therapeutic solutions.
Emergent will provide access to manufacturing capacity reserved for and 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), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services. Lenzilumab is currently in a Phase 3 clinical trial evaluating patients hospitalized with COVID-19. Humanigen intends to file for emergency use authorization (EUA) in the first quarter of 2021.
Under the terms of the agreement, Emergent will provide its integrated CDMO services for the manufacturing of drug product batches to support Humanigen’s efforts to increase supply of lenzilumab in anticipation of a potential EUA beginning in the first quarter of 2021, including utilization of a new state-of-the-art flex fill line at Emergent’s Baltimore, MD (Camden) drug product manufacturing facility. This newly 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,” said Cameron Durrant, chief executive officer, Humanigen. “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 and is in addition to the landmark public-private CDMO partnership between Emergent and BARDA, announced in June 2020, to pave 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,” said Syed T. Husain, senior vice president and CDMO business unit head, Emergent BioSolutions. “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 agreement marks Emergent’s seventh CDMO collaboration with government and industry partners working to deliver COVID-19 vaccine and therapeutic solutions.
