Long-Acting Antibody Combination Heads to Phase 3 Trials for COVID-19

AstraZeneca’s investigational long-acting antibody (LAAB) combination will advance into phase 3 clinical trials for coronavirus disease 2019 (COVID-19).

According to AstraZeneca, the company has received around $486 million from the US government for the development and supply of AZD7442 under an agreement with the Biomedical Advanced Research and Development Authority (BARDA).¹

AZD7442, a combination for 2 LAABS derived from convalescent patients after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was discovered by Vanderbilt University Medical Center (VUMC) and licensed to AstraZeneca in June 2020.^1,2

According to VUMC, the 2 antibodies that make up AZD7442 were isolated by the VUMC team from the blood of a couple from Wuhan, China, who had been diagnosed with COVID-19 after traveling to Toronto, Canada, in late January. Early research showed that, in pre-clinical experiments, the LAABs blocked the binding of the SAR-CoV-2 virus to host cells and protected against infection in cell and animal models of the disease.²

“LAABs mimic natural antibodies and have the potential to treat and prevent disease progression in patients already infected with the virus, as well as to be given as a preventative intervention prior to exposure to the virus,” AstraZeneca said in its press release.¹ “A LAAB combination could be complementary to vaccines as a prophylactic agent, eg for people for whom a vaccine may not be appropriate or to provide added protection for high-risk populations. It could also be used to treat people who have been infected.”

AstraZeneca will conduct 2 phase 3 studies of AZD7442. One trial will enroll approximately 5000 participants to examine the safety and efficacy of AZD7442 to prevention COVID-19 infection for up to 12 months. The second trial will evaluate post-exposure prophylaxis and pre-emptive treatment in approximately 1100 participants. Additional trials will also evaluate the treatment in approximately 4000 patients for the treatment of COVID-19.¹

“The agreement with the US government will help accelerate the development of our long-acting antibody combination which has the potential to provide immediate and long-lasting effect in both preventing and treating COVID-19 infections,” Pascal Soriot, chief executive officer of AstraZeneca, said in a statement.¹ “We will be evaluating the LAAB combination in different settings from prophylaxis, to outpatient treatment to hospitalization, with a focus on helping the most vulnerable people.”

AstraZeneca plans to supply up to 100,000 doses starting toward the end of 2020 and the US government can acquire up to an additional 1 million doses in 2021 under a separate agreement, the pharmaceutical company said.¹

AZD7442 is among several antibody treatments being tested clinically for COVID-19.²

References:

1. COVID-19 Long-Acting Antibody (LAAB) combination AZD7442 rapidly advances into Phase 3 clinical trials. News release. AstraZeneca; October 9, 2020. Accessed October 14, 2020. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/covid-19-long-acting-antibody-laab-combination-azd7442-rapidly-advances-into-phase-iii-clinical-trials.html#!
2. COVID-19 long-acting antibodies discovered by Vanderbilt University Medical Center move to phase 3 clinical trials. News release. Vanderbilt University Medical Center; October 13, 2020. Accessed October 14, 2020. https://news.vumc.org/2020/10/13/covid-19-long-acting-antibodies-discovered-by-vanderbilt-university-medical-center-move-to-phase-3-clinical-trials/​