Weeks after announcing that its lead monoclonal antibody was demonstrating efficacy against the Omicron variant, Adagio Therapeutics CEO Tillman Gerngross steps down.
Weeks after announcing that its lead monoclonal antibody, ADG20, was demonstrating efficacy against the Omicron variant of the SARS-CoV-2 virus, Adagio Therapeutics Chief Executive Officer Tillman Gerngross announced he was stepping down from his position.
In a Friday filing with the U.S. Securities and Exchange Commission, Adagio announced that Gerngross intended to step down from his position but provided no details regarding that decision. The company noted that Gerngross and the company’s chairman of the board of directors “agreed in principle” to the resignation. Adagio did not provide an indication as to whether or not Gerngross was leaving the company entirely or if he would retain his seat on the board of directors.
Taking over as interim CEO is David Hering, chief operating officer of Adagio. Prior to joining Adagio, Hering led Pfizer’s mRNA franchise, which includes the company’s COVID-19 vaccine co-developed with Germany-based BioNTech.
In a brief statement, Hering noted the company intends to put out a statement regarding the CEO transition as well as an update on its pipeline.
“We have built a strong foundation for Adagio as a late-stage stage development company with the resources in place to execute the work ahead,” Hering said in a press release. “We have great confidence in the deep expertise of the entire Adagio team as we move to our next phase of long-term success and growth.”
While there is no update on the CEO transition, Adagio announced strategic initiatives for its ADG20 program this morning. Based on Phase II/III clinical development data, Adagio said it is assessing the potential for Emergency Use Authorization submissions for ADG20 for the prevention and treatment of COVID-19. Waltham, Mass.-based Adagio has suggested that its monoclonal antibody is on par with the only two drugs of its type currently authorized against COVID: Vir and GlaxoSmithKline’s sotrovimab, which has been authorized for treatment of early COVID-19, and AstraZeneca’s Evusheld, which was authorized for the pre-exposure prophylaxis (prevention) of COVID-19 in some adult and pediatric patients.
Adagio said this morning that before the end of the first quarter of 2022, the company intends to undertake several strategic actions for ADG20, including the analysis of the ongoing Phase II/III EVADE and STAMP studies to assess the safety and efficacy of 300 mg of the monoclonal antibody in each trial. The analysis will be finalized in March, and Adagio said it will inform its next steps for ADG20 from there.
Additionally, the company intends to assess higher doses of ADG20 in a Phase I clinical trial to supplement the 300mg dose data and advance the ongoing efforts to modify ADG20 to improve binding to the Omicron variant. These modifications are expected to enhance its neutralization potency, along with broad neutralization that has been shown in vitro against other SARS-CoV-2 variants of concern.
Adagio said ADG20 has demonstrated in vitro neutralizing activity against Alpha, Beta, Delta, Delta Plus, Gamma and the BA.1 lineage of the Omicron variant. The company also stated that following in vitro assays, ADG20 has “markedly reduced neutralization activity against the BA.2 lineage of the Omicron variant.”
