Hoping to still make the case for an FDA authorization for its COVID-19 antibody, Adagio Therapeutics is making modifications and exploring higher doses in search of an omicron offense.
Reporting first quarter earnings Friday, the infectious disease biotech provided an update on work with adintrevimab, the broadly neutralizing antibody intended to prevent and treat COVID-19. But the therapy has only proven it can work so far against older variants. When put up against omicron, the lead antibody candidate couldn’t fight back.
Adagio has tried to plow on, making a pitch for FDA authorization based on data in older variants—a long shot as the virus has outpaced therapeutic development and caused the FDA to limit or cut use of previously authorized therapies from bigger companies.
Now, interim CEO David Hering says some changes are afoot. Adagio is plugging away at efforts to “improve antibody activity to the omicron variant,” he said in the earnings statement. That includes modifications to adintrevimab, which were not defined, and higher dosing in an ongoing phase 1 trial.
“We continue to be encouraged by adintrevimab’s potential as a prophylactic and treatment option for certain variants of SARS-CoV-2, which is supported by the positive data that met all primary endpoints from our global EVADE and STAMP trials,” Hering said.
Meanwhile, Adagio is going back to the drawing board to develop next-generation monoclonal antibodies—having never achieved the first generation at least for COVID-19.
The company has capital to run operations through the second half of 2024 with $532.2 million in cash on hand as of the end of March. R&D efforts drained $92 million in the first quarter of the year compared to $34 million for the same period a year before. Adagio attributed the uptick to manufacturing validation, supply activities and ongoing clinical trial expenses.
Adagio will present data from a phase 2/3 trial of adintrevimab in ambulatory patients with mild to moderate COVID-19 at the upcoming American Society for Microbiology annual meeting in June.
Hering replaced founding CEO Tillman Gerngross, Ph.D., who resigned suddenly in February. Prior to joining Adagio, Hering was head of Pfizer’s mRNA global franchise where he helped launch the COVID-19 vaccine as president of North America.