The race to develop antibody-based drugs for the new coronavirus is primarily led by larger drugmakers and biotechs. But a new startup formed by one of the sector's more prolific antibody makers thinks it can contribute as well, and perhaps help prepare for future coronavirus outbreaks too.
That startup, dubbed Adagio Therapeutics, has been spun out of Adimab, a privately-held company whose antibody technology is used by dozens of biotech and pharma companies — among them Biogen, GlaxoSmithKline and Novartis.
Adagio will launch with $50 million in venture backing and license to a portfolio of coronavirus-fighting antibodies developed within Adimab, the first of which should be ready for human testing by the end of the year, according to CEO and co-founder Tillman Gerngross.
There is an urgent need to develop engineered antibodies — which are meant to mimic the infection-fighting proteins the human body naturally produces — against COVID-19. Though a large slate of experimental coronavirus vaccines are moving forward at a record pace, it's still uncertain whether one will effectively prevent infections, how long immunity might last and whether they'll help the most vulnerable, like the elderly or people with weak immune systems.
"If I had the sense that vaccines are going to be highly efficacious, we would have not spun off Adagio," Gerngross said. "Antibodies, over the next six months, are going to be looked at as where the solution is going to come from."
It's a belief shared by some of the nation's leading health experts. Antibodies "might be a bridge to a vaccine," wrote Scott Gottlieb, the former head of the Food and Drug Administration in a recent op-ed. On a call with reporters this week, Janet Woodcock, a top FDA drug official, singled out antibody-based treatments as a major focus of U.S. government efforts to speed development of coronavirus drugs.
Antibodies don't offer the long-lasting protection that a vaccine can, but they work quickly, and could conceivably treat sick patients or prevent infections from developing in those who have been exposed. Effective antibodies have been produced for other viral infections like Ebola and respiratory syncytial virus.
Regeneron and Eli Lilly — large companies well versed in making antibody drugs — already have engineered antibodies targeting SARS-CoV-2 in human testing. Vir Biotechnology, AstraZeneca, AbbVie, Amgen and others could soon follow. These companies are moving extremely fast, using adaptive trial designs and other measures to accomplish in months what usually takes years. Regeneron has said it aims to generate enough evidence to support an emergency approval for its antibody cocktail by the end of the year.
Adagio, then, will need to work quickly to be relevant. The startup is backed by some notable firepower, however. It's also led by Gerngross, a biochemical engineer and Dartmouth University professor turned serial biotech entrepreneur who built and sold GlycoFi — whose technology made proteins from yeast — to Merck for $400 million. Merck eventually shuttered GlycoFi, but Gerngross achieved another milestone with his next company, Adimab, by turning it into a self-sustaining biotech.
Some 40 Adimab antibodies are in clinical development within various companies, and one approved drug — the Innovent and Eli Lilly cancer medicine Tyvyt — has come from the effort. Adimab has spun out multiple startups as well, the latest being Adagio.
Unlike many antibody developers taking aim at the new coronavirus, Adagio aims to develop drugs that neutralize multiple coronavirus types, not just SARS-CoV-2, the source of the current pandemic. The idea is to have a group of antibodies that can thwart future potential coronavirus outbreaks.
That's a "major hole in our armamentarium today," said Marc Elia, a co-founder of M28 Capital, an investor in Adimab who joined the round for Adagio.
The work underpinning the startup was published in the journal Science in June, and showed Adimab's engineered antibodies could neutralize a variety of coronavirus types, including the one that caused the SARS outbreak in 2003 and two currently circulating in bats. A portfolio of those antibodies was licensed to Adagio.
A single antibody meant to prevent coronavirus infection is headed to human testing first, while other antibody cocktails that would be used therapeutically for sick patients would come afterwards, Gerngross said.
Adagio is designing its antibodies to last six months, so people would only need to get two shots each year. Antibodies from Regeneron and Lilly that are in human testing are anticipated to last about a month, though Vir and others are advancing candidates that could last longer.
As a startup, however, Adagio faces several major disadvantages. A particularly notable hurdle is manufacturing, as even Regeneron has indicated it might need alliances to meet the potentially massive global demand for a successful antibody drug for coronavirus infection. Gerngross said Adagio aims to show a 100 milligram dose twice a year can work, which could make supplying millions of doses annually doable "without heroic efforts."
Larger drugmakers also have the financial power to quickly ramp up the big clinical trials needed to prove out a new treatment. The $50 million round just gets Adagio to the clinic, though Gerngross expects additional money to be there — from an initial public offering, private investors or others — if Adagio can prove a "profound disease-modifying effect."
"If we deliver on that," he said, "I'm not too worried about raising money."