Already part of several collaborations for COVID-19 vaccine candidates, Gaithersburg-based Emergent BioSolutions announced Monday that it will manufacture a potential treatment for the coronavirus called lenzilumab.
The drug, which is being developed by California-based Humanigen, Inc., is currently being tested in a phase 3 trial on hospitalized COVID-19 patients. It aims to prevent and treat “cytokine storm,” a severe, sometimes deadly, immune system reaction that can be caused by COVID-19.
“Drug product manufacturing is a hallmark capability of our CDMO (contract development and management organization) 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 in a statement. “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.”
Humanigen will be using manufacturing capacity reserved for the Biomedical Advanced Research and Development Authority, a U.S. Department of Health and Human Services office that works to procure and develop medical responses to pandemics, emerging diseases and bioterrorism.
BARDA has reserved $542.7 million in Emergent BioSolutions’ manufacturing capacity for government-backed COVID-19 vaccine candidates under Operation Warp Speed, the federal government’s program to expedite the creation of COVID-19 vaccine candidates, established last May. The agreement also put $85.5 million towards expanding the company’s fill and finish — the process of filling and packaging vials of medication — capacities, at both its Camden and Rockville facilities. This brand new technology will be used in the manufacturing of lenzilumab.
Humanigen was granted access to this reserved capacity last week after BARDA co-signed an existing cooperative research and development agreement that Humanigen established with the Department of Defense last November.
This is the first COVID-19 treatment being manufactured by Emergent BioSolutions through this partnership, though the company is already partnering with the developers of a number of vaccine candidates, including AstraZeneca, Johnson & Johnson, Novavax, Inc. and Vaxart, Inc.
Overall, Emergent BioSolutions’ CDMO portfolio includes around 60 organizations and 90 projects.
Humanigen plans to file for emergency use authorization for the product within the first quarter of 2021.
“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 of Humanigen.
The two companies also intend to negotiate a long-term commercial supply agreement, Husain said. Emergent BioSolutions did not disclose the financial details of the agreement.