Vaccine Info

COVID-19 Long-Acting Antibody (AZD7442)

COVID-19 Long-Acting Antibody (AZD7442) Description

COVID-19 Long-Acting Antibody (AZD7442) has been engineered with AstraZeneca’s proprietary half-life extension technology to increase the durability of the therapy for six to 12 months following a single administration.

AstraZeneca's COVID-19 Long-Acting Antibody (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.

This LAAB combination (AZD8895 + AZD1061) could be complementary to vaccines as a prophylactic agent, e.g. 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.

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the LAABs were optimized by AstraZeneca with half-life extension and reduced Fc receptor binding. The half-life extended LAABs should afford six to 12 months of protection from COVID-19. The reduced Fc receptor binding aims to minimize the risk of antibody-dependent enhancement of disease, a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection, and/or disease.

In a recent Nature publication, the LAABs were shown in pre-clinical experiments to block the binding of the SARS-CoV-2 virus to host cells and protect against infection in cell and animal models of disease.

Pascal Soriot, AstraZeneca's CEO stated on October 9, 2020: “This agreement with the US Government will help accelerate the development of our long-acting antibody combination which has the potential to provide an immediate and long-lasting effect in both preventing and treating COVID-19 infections. 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 is a global, science-led biopharmaceutical company.

COVID-19 Long-Acting Antibody (AZD7442) Indication

AZD7422 (AZD8895 + AZD1061) is indicated to prevent infection from the SARS-CoV-2 virus, as well as treat patients who have become infected by the SARS-Cov-2 coronavirus and developed COVID-19 disease.

Participants randomized to AZD7442 will be administered dose 1, each in Cohort 1a (IM) and Cohort 1b (IV). Participants in Cohort 2 and 3 will receive AZD7442 (IV) doses 2 and 3, respectively.

COVID-19 Long-Acting Antibody (AZD7442) News

October 9, 2020 - Two trials of AZD7442 will enroll over 6,000 adults for the prevention of COVID-19 with additional trials enrolling ~4,000 adults for the treatment of SARS-CoV-2 infections.

July 15, 2020 - Study published by Nature: Potently neutralizing and protective human antibodies against SARS-CoV-2.

April 8, 2020 - The Chinese Academy of Sciences and Vanderbilt University Medical Center are providing AstraZeneca with genetic sequences for antibodies they have discovered against SARS-CoV-2 for further in silico and in vitro assessment.

COVID-19 Long-Acting Antibody (AZD7442) Clinical Trials

Clinical Trial NCT04507256:  AZD7442 is a Potential Combination Therapy for the Prevention and Treatment of COVID-19. Last Update Posted: August 31, 2020.

  • In this first-in-human dose-escalation study, AZD7442 (AZD8895 + AZD1061) will be evaluated for safety, tolerability, pharmacokinetics, and generation of anti-drug antibodies (ADAs). The study is intended to enable future studies of AZD7442's efficacy in preventing and treating COVID-19.
  • The study will comprise of: A Screening Period of up to 27 days (Day -28 through Day -2); A Treatment Period during which participants will be resident at the Clinical Unit from Day -1, 1 day before Investigational Medicinal Product (IMP) administration (on Day 1) until at least 24 hours after IMP administration, will be discharged on Day 2 after all safety evaluations have been completed, and a Follow up Period lasting 360 days (through to Day 361) after the IMP dose.

Updated
10/13/2020 - 09:58