Adagio Studying its Monoclonal Antibody for Prevention and Treatment of COVID-19

Last summer, Adagio Therapeutics was launched by its parent company, Adimab. The spin-off company is going to focus on developing anti-coronavirus antibodies as both therapeutics and prophylactics against COVID-19 and future coronaviruses.

The company’s investigational therapy, ADG20, is a monoclonal antibody developed for both the treatment and prevention of COVID-19. ADG20 was designed and engineered to possess high potency and broad neutralization against SARS-CoV-2 and additional clade 1 sarbecoviruses, by targeting a highly conserved epitope in the receptor binding domain. ADG20 is delivered via intramuscular administration instead of intravenously.

With the rise of variants, concerns over efficacy for COVID-19 vaccines and therapies has been raised. Adagio says it has kept the evolving variants in mind when it developed its monoclonal antibody and has demonstrated effectiveness against them.

The company reported data at the recent MAD-ID virtual conference. “The most important takeaway [from the data reported at the conference] would be the antibody shows very broad and potent activity across SARS-CoV-2, variants of SARS-CoV-2 including the B.1.1.7 variant, B.1.351, P1, and other SARS-like viruses,” Laura Walker, senior director of Antibody Sciences at Adimab, and chief scientific officer, Adagio Therapeutics, said.

Adagio announced in early May that it had treated the first patient in its phase 2/3 EVADE trial evaluating ADG20 for the prevention of COVID-19. Trial initiation is supported by positive preliminary data from the company’s ongoing phase 1 trial in healthy volunteers.

The EVADE trial is a global, multi-center, double-blind, placebo-controlled clinical trial evaluating ADG20 in two independent cohorts. The first cohort (post-exposure prophylaxis) is designed to assess the safety and efficacy of ADG20 compared to placebo for the prevention of COVID-19 after exposure to an individual with laboratory confirmed SARS-CoV-2 infection.

The second cohort (pre-exposure prophylaxis) is designed to assess the efficacy and safety of ADG20 compared to placebo in individuals who are at increased risk for SARS-CoV-2 infection due to occupational, housing or recreational situations, and in individuals who are at increased risk of poor vaccine response, including individuals with compromised immune systems or other comorbidities.

EVADE will be conducted globally at more than 100 sites, including in regions where there is a high prevalence of SARS-CoV-2 variants of concern, and will evaluate the ability of a single, intramuscular dose of ADG20 to prevent COVID-19 in both pre- and post-exposure settings.

In addition to the EVADE trial, ADG20 is being studied in 2 other trials: the ongoing phase 1 clinical trial of ADG20 in healthy volunteers and the ongoing STAMP trial evaluating ADG20 as a treatment for high-risk individuals with mild or moderate COVID-19.

Contagion recently spoke to Walker about the history of the ADG20 platform, how Adagio’s broadly neutralizing therapy is designed to address these mutations and insights into their ongoing trials.