Manufacturing powerhouse Emergent BioSolutions unveiled its seventh COVID-19 CDMO tie-up Monday, this time to help crank out Humanigen’s late-stage antibody hopeful lenzilumab.
Emergent will hustle along fill-finish work on lenzilumab at its Camden plant in Baltimore, boosting supplies ahead of a possible emergency nod early this year. Humanigen’s monoclonal antibody, designed to treat and prevent the immune hyper-response known as cytokine storm, is currently in a phase 3 trial in hospitalized patients, and the company says it expects to file for an emergency use authorization in 2021’s first quarter.
Emergent will start churning out lenzilumab batches within 90 days of Monday's announcement, leveraging a new flex-fill line at its Camden plant. That line became operational in January following the acceleration of a $50 million expansion announced in 2018, Syed Husain, senior vice president and CDMO business unit head at Emergent, said over email.
Looking ahead, the companies plan to hash out a commercial manufacturing agreement that could include future fill batches for a biologics license application—necessary to transform Humanigen’s potential EUA into a full FDA approval, the pair said in a statement.
As it stands, Humanigen aims to produce 100,000 lenzilumab treatments this year, Cameron Durrant, M.D., chairman and CEO of the company, told Fierce Pharma. The latest pact marks Humanigen’s ninth partnership to help bring lenzilumab to market, he said.
The company has been building out its manufacturing infrastructure in anticipation of a green light this quarter, buoyed by support from the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) and the Trump administration’s Operation Warp Speed initiative, he added.
Friday, Humanigen announced an expansion to the agreement it first inked with BARDA in November, providing the company with reserved manufacturing capacity for lenzilumab—capacity Emergent will now help Humanigen utilize, Durrant said.
Should lenzilumab pass muster in the clinic, it will become the third antibody drug authorized in the U.S. behind Eli Lilly’s bamlanivimab and Regeneron’s casirivimab and imdevimab antibody cocktail. Back in November, Humanigen offered a sneak peak at the phase 3 data for its drug, which it estimated led to 37% more recoveries than standard care alone in hospitalized patients.
Emergent, for its part, has become a household name when it comes to pandemic manufacturing deals. The Humanigen collaboration makes seven for the Gaithersburg, Maryland-based CDMO, which is also on deck to help produce vaccines for AstraZeneca, Johnson & Johnson, Novavax and Vaxart.
On the therapeutics front, Emergent in April teamed up with the U.S. government to speed development on a human immune globulin plasma-derived therapy against COVID-19, and, three months after that, it signed on the Mount Sinai Health System and ImmunoTek Bio Centers—a fledgling biotech focused on plasma collection—to assist with the project.
Emergent’s deal with the feds is nothing to sneeze at, either. BARDA in June shelled out an eye-popping $628 million to Emergent to scale production of pandemic vaccine candidates, with a view to make “tens to hundreds of millions” of doses available through 2021.
The government partitioned $542.7 million of that to reserve bulk manufacturing capacity at Emergent’s Baltimore Bayview site—which BARDA in 2012 helped build out into a pandemic response site. The remaining $85.5 million was earmarked to expand fill-finish capacity at two Emergent plants in Rockville, Maryland, and Baltimore, where the manufacturer will now produce Humanigen’s drug.