Adagio Therapeutics has nabbed a massive $336 million series C from a who’s who of investors as it more than triples its previous funding drive last year.
The company raised $50 million in its debut last year and $80 million in November; Now, as vaccines start to play a bigger part in global protection, there is still a major need for a bespoke treatment to help those who are still getting infected and reduce their risk of severe illness or death.
The company is developing its lead prospect, ADG20, for the prevention of COVID-19 infection as well as for the treatment of patients who have fallen ill. It may be zeroing in on SARS-CoV-2—the virus that causes COVID-19—but ADG20 and Adagio’s other antibodies are designed to protect against other coronaviruses, too. They bind to a piece of the spike protein that is found on multiple viruses, including SARS-CoV-1 and some coronaviruses circulating in bats.
It now has an extra $336 million in the bank for its clinical plans, with the cash coming from RA Capital Management, which led the round, with help from a host of new investors including Redmile Group, Federated Hermes, Foresite Capital, ArrowMark Partners, PremjiInvest and another leading healthcare investor.
Existing investors Fidelity Management & Research Company, LLC, OrbiMed, Polaris Partners, Mithril, GV, Population Health Partners, Adimab and Omega Funds also put in cash for the financing.
It will hope to have better luck than Eli Lilly, which had its antibody from AbCellera saw its emergency use authorization pulled late last week by the FDA, after it was found not to work well enough against the new variants. The pharma is now looking to antibody combos to boost efficacy. Adagio, however, believes it can prove better at knocking down new variants.
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Just last week, the biotech began recruitment in a test for ADG20. The study is assessing the effect of a single dose of ADG20 on patients with mild to moderate COVID-19 and a high risk of disease progression, and it will hope to ramp up quickly to fill the large drug gap in the COVID treatment paradigm.
Tillman Gerngross, Ph.D., set up Adagio early in the pandemic to develop antibodies that neutralize SARS-CoV-2 and related coronaviruses. Adagio has retained that focus as vaccines and rival antibodies have come to market, reflecting a belief that there remains a need for its candidate in a world that faces SARS-CoV-2 variants and the persistent risk of other SARS-like viruses.
Adagio began dosing healthy volunteers with ADG20 in February, setting it up to move into a phase 1/2/3 clinical trial in COVID-19 patients. The team will assess intramuscular and intravenous doses of ADG20 against different endpoints as the study moves through its three phases.
The phase 3 part of the study is designed to show the effect of ADG20 on COVID-19 hospitalizations and all-cause death through Day 29. If the study goes to plan, Adagio expects to report initial results, which could support early patient access to ADG20, by the end of the year.
That timeline means ADG20 could come to market around one year after the first anti-SARS-CoV-2 antibodies and COVID-19 vaccines. By then, vaccination campaigns may have reduced case counts to low levels by the standards of the past year. Even so, Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio, sees a need for ADG20.
“With its potential to address resistant variants and ability to be easily administered as a low dose, affordable, intramuscular injection in the outpatient setting, ADG20 is uniquely poised to address the current need for effective, safe and convenient outpatient therapy for individuals at high risk of disease progression,” Connolly said.
ADG20 could address those needs in parts of the world where variants with some level of resistance to existing neutralizing antibodies are dominant. Having set out to develop an antibody that works against SARS-CoV-2 and other clade 1 sarbecoviruses, Adagio created a therapy that targets a highly conserved epitope that is found in COVID-19 variants.
Researchers at the University of Oxford found ADG20 maintains its potency against P.1 and B.1.351, the variants that originated in Brazil and South Africa. Adagio has previously discussed its intention to test ADG20 in countries that have high levels of resistant variants.
It hopes the latest trials, when finished, will help it toward a speedy emergency use authorization.
“The COVID-19 pandemic continues to be a major health crisis worldwide, and even with emergency use authorizations for vaccines and antibody-based therapies, there remains a significant need for medications to treat and prevent COVID-19 infection. We are advancing ADG20 through a rapid development strategy based on preclinical data that demonstrate its best-in-class potential for treating all known variants of COVID-19 today,” said Gerngross.
“This financing is a testament to the quality of our science, the relentless execution by the Adagio team and to Jane Henderson, who joined us as CFO earlier in the year and brings a 32-year track record of financial and corporate strategy, execution and operations. With the support of this sophisticated group of investors, we are properly capitalized to continue our expedited development and ultimate commercialization of ADG20 to benefit the many people at risk of COVID-19 mortality.”