Six drugmakers working on COVID-19 antibody treatments want to swap information and scale up production before those therapies win approval—and now they have Justice Department approval to share their need-to-know secrets.
Eli Lilly, AstraZeneca, Roche's Genentech unit, Amgen, GlaxoSmithKline and Lilly partner AbCellera can now share manufacturing information that could help speed up coronavirus antibody production, thanks to a business review letter from the Justice Department's antitrust division.
The cadre of drugmakers—all in different stages of antibody development—will share information about their manufacturing facilities, capacity, raw materials and other supplies needed to pump out successful monoclonal antibodies. Through the collaborative effort, the six firms aim to lock down manufacturing capacity so they can deliver their COVID-fighting treatments right out of the gate after regulatory approval.
Two things those drugmakers can't collaborate on, though? Production costs and pricing. The DOJ believes sharing that info could lead to anticompetitive behavior.
The rest of the collaboration could grant Americans access to potentially life-saving treatments sooner—and without stymying competition from other developers plotting antibody therapies for COVID-19.
"The demand for monoclonal antibodies targeting COVID-19 is likely to exceed what any one firm could produce on its own," the DOJ said in its letter. "Moreover, waiting until regulators approve specific treatments before scaling up manufacturing might delay access to these potentially life-saving medicines by many months, which adversely could affect the nation’s efforts to fight COVID-19."
Monoclonal antibodies, which bind to targeted cells and tee them up for elimination by the body's immune system, have become a hot ticket item in the realm of COVID-19 treatment. In addition to their use as a therapy to curb COVID-19 symptoms, monoclonal antibodies could potentially halt infection, too, providing a much-needed alternative for those who are vaccine-sensitive, like the elderly and the immunocompromised.
NIAID Director Anthony Fauci has pointed to antibody treatments several times as an exciting prospect that could keep patients with milder cases of COVID-19 from progressing to hospitalization. In a Medscape interview, Fauci also highlighted the success of two earlier antibodies—monoclonal antibody 144 and a Regeneron-made product—shown to slash death rates in Ebola patients last year.
Notably absent from the collaboration project was Regeneron. The Tarrytown, New York-headquartered biotech first pushed its antibody cocktail, dubbed REGN-COV2, into clinical trials in June. The treatment was created by selecting hundreds of neutralizing antibodies against SARS-CoV-2 from a mouse model and humans who recovered from the virus. The company ultimately settled on two of the most potent antibodies, pairing them to prevent a viral mutation from evading treatment.
In July, Regeneron signed a $450 million deal with the Trump administration to supply 1.6 million doses of its antibody cocktail, possibly by summer's end, the company said. Because the biopharma is still pinning down dosage, that order could eventually cover 70,000 to 300,000 treatment courses and 420,000 to 1.3 million preventive courses. The cocktail recently launched into a phase 3 prevention trial and is plugging along in two phase 2 treatment studies.
Meanwhile, Eli Lilly started dosing COVID-19 patients in a phase 1 trial of its AbCellera-partnered antibody therapy last month. The companies said they expected results by the end of June, but that trial data hasn't yet appeared. A little over a week after the Lilly-AbCellera announcement, AstraZeneca revealed it had snagged the license for six coronavirus-neutralizing antibodies from Vanderbilt University, with plans to advance a pair into testing as a combo treatment for COVID-19.
And earlier this month, GlaxoSmithKline shelled out £234 million ($294 million) to Germany's CureVac to collaborate on mRNA-based vaccine and monoclonal antibody development. Under the deal, GSK will fund CureVac's COVID-19 research before stepping in to push those shots and therapies into clinical testing, with CureVac retaining marketing rights in selected countries.