Adagio Therapeutics Inc. is riding high after the company said its experimental antibody is likely to be just as effective against the omicron variant of the coronavirus as it is against previous variants. The antibody, a drug called ADG20, affords protection for up to one year, according to the firm, and is also being tested as a treatment for those already infected.
Adagio (Nasdaq: ADGI) shares had spiked by more than 80% by 2 p.m. Monday, trading at about $46 and giving the Waltham-based biotech, which held its IPO just a few months ago, a market cap of almost $4.9 billion.
Adagio launched in the summer of 2020 with the singular mission of advancing a portfolio of coronavirus antibodies. Co-founder and CEO Tillman Gerngross believes extremely potent antibodies will be key in the fight against the pandemic, especially as other treatments and preventive measures wane in the face of new, more transmissible variants like omicron. ADG20 is given as a single shot in an outpatient setting, a crucial difference from the currently authorized monoclonal antibodies that must be given as infusions inside hospitals.
Another major difference: ADG20 targets a specific epitope on the virus’s receptor binding site that is not targeted by any authorized antibodies, making the epitope less subject to “immune pressure,” the company says. ADG20 is unaffected by mutations to the virus’s spike protein that have showed up in the omicron variant.
“We, from the beginning, predicted exactly what is happening now. We said that the Greek alphabet has 24 letters, and we have a long way to go,” Gerngross told the Business Journal. “The only way to really hedge against the viral escape that we’re seeing is to come up with antibodies that target residues on the receptor binding domain. We did the work to do that. We ended up engineering antibodies that are extremely potent and that have this broad recognition.”
Adagio is testing ADG20 both as a prophylactic, to prevent Covid-19, and as a treatment for mild to moderate cases of the disease. Phase 2/3 trials are ongoing at more than 100 sites globally — including several in South Africa, which first sequenced the omicron variant — to account for variants of concern. Fittingly, Adagio is calling the study “EVADE.” Adagio expects results in mid-2022, although Gerngross noted that interim data will be available before that.
Adagio is additionally developing a suite of other, “backup” antibodies should a variant emerge that escapes the reaches of ADG20. The company says that ADG20 has so far been effective against the ancestral strain of SARS-CoV-2 (the scientific name for the novel coronavirus) as well as the alpha, beta, delta and gamma variants.
“It neutralized SARS 1. It will neutralize SARS-CoV-2 and all its known variants,” Gerngross said. “That’s the strategy we had articulated at the beginning.”
Grossman also believes it’s time for a “Warp Speed 2.0” from the White House. He credits the program with the quick development of vaccines and first-generation antibodies, and he would like to see the government similarly back responses to new threats. Not that Adagio isn’t well financed. The company held one of the largest IPOs of the year at $309 million in August. Before that, it had raised nearly $500 million across three rounds from the likes of RA Capital Management, Redmile Group, Fidelity Management and Research and Polaris Partners, among others.
Adagio plans to submit data for approval not only to the U.S. Food and Drug Administration but to regulatory agencies around the globe. In July, the company signed an agreement with Biocon Ltd., India’s largest biologics firm, under which it will provide Biocon with materials and instructions to manufacture and commercialize an antibody treatment based on ADG20 in southern Asia.
“The goal was to make this drug as broadly available and to touch as many lives as possible,” Gerngross said.