AstraZeneca, US Gov’t in $486-M Pact for COVID-19 Antibody ComboBy
AstraZeneca has been awarded up to $486 million from the US government for the late-stage development and large-scale manufacturing of the company’s AZD7442, a cocktail of two monoclonal antibodies, for the potential treatment or prevention of SARS-CoV-2, the virus that causes COVID-19.
Under the agreement, the US government will provide approximately $486 million to AstraZeneca for two Phase III clinical trials and related development activities, including a large-scale manufacturing demonstration project and supply of AZD7442 doses in the US. One trial will evaluate the safety and efficacy of AZD7442 to prevent infection for up to 12 months in approximately 5,000 participants. The second trial will evaluate post-exposure prophylaxis and pre-emptive treatment in approximately 1,100 participants. AstraZeneca says it is planning additional trials to evaluate AZD7442 in approximately 4,000 patients for the treatment of COVID-19.
AstraZeneca also says it plans to supply up to 100,000 doses starting toward the end of 2020 and that the US government can acquire up to an additional one million doses in 2021 under a separate agreement.
The agreement builds on previous funding of more than $25 million from US government agencies, the Biomedical Advanced Research and Development Authority (BARDA) under the US Department of Health and Human Services and the Defense Advanced Research Projects Agency for the discovery and evaluation of the monoclonal antibodies as well as the Phase I clinical trial that started in August 2020 to assess safety, tolerability, and pharmacokinetics of AZD7442 in healthy individuals.
AZD7442 is a combination of two monoclonal antibodies discovered by Vanderbilt University, licensed to AstraZeneca, and modified using AstraZeneca’s proprietary half-life extension technology to extend their duration of action (the amount of time that the antibodies remain in the body).