Adagio Therapeutics has filed an initial public offering to raise money to bring its COVID-19 antibody to market. The IPO will support phase 2/3 clinical trials that Tillman Gerngross’ Adagio is running to position ADG20 for the treatment and prevention of COVID-19.
Adimab-spinout Adagio has succeeded in attracting investor support for its anti-SARS-CoV-2 antibody even as rival assets have come to market and vaccines have curbed the crisis in some countries. The biotech is now aiming to follow up the monster $336 million series C round raised in April with an IPO that will equip it to take ADG20 through to initial commercialization.
Adagio has taken ADG20 into phase 2/3 treatment and prevention clinical trials on the strength of early-phase data. The treatment trial, called STAMP, is enrolling mild-to-moderate COVID-19 patients at high risk of disease progression to generate data to support commercial launch in 2022.
The IPO paperwork reveals Adagio modified the design and conduct of the STAMP trial “exclusively outside of the United States” after the FDA said “it had changed its view on allowing high risk patients to be randomized to placebo.” Adagio now intends to conduct its STAMP treatment trial at sites outside of the U.S., provided overseas regulators support its plans.
“Applicable foreign regulatory authorities may determine that a placebo-controlled trial would expose patients to unacceptable health risks (for example, if alternative effective therapies become available in these regions during the conduct of the trial), which could delay enrollment of our trial and the authorization or approval of ADG20,” Adagio wrote in its IPO paperwork.
The IPO paperwork pulls back the curtain on other previously hidden aspects of the privately held biotech. For example, Adagio cites its reliance on service provider WuXi as a risk factor, adding that a change to Chinese export procedures delayed a shipment of ADG20 from the supplier late last year.
Adagio also flagged up potential intellectual property issues to the investor community. In October, a “third party claimed that one of its employees should be listed as an inventor on certain of our patent applications claiming SARS-COV-2 binding antibodies or their preparation,” the paperwork states. Adagio believes the claim is “without merit” but warned it “could result in the loss of our exclusive rights in our technology.”
The broader challenge for Adagio is delivering on its promise of establishing ADG20 as an important part of the treatment toolkit in the postvaccine phase of the pandemic. Adagio argues there remains a need for anti-SARS-CoV-2 antibodies because of the threat of variants, gaps in vaccine coverage and questions over the duration of immunity. Adagio’s focus on an epitope that is found across multiple SARS-like viruses suggests ADG20 could fare better than other antibodies against variants.