AstraZeneca’s Covid-19 LAABS antibody combination, AZD7442, will advance into two Phase III trials in more than 6,000 participants at sites inside and outside the US in the coming weeks.
The antibodies could treat Covid-19 patients or be used in cases where individuals are at high risk of the virus or cannot take a vaccine.
AstraZeneca employs 1,500 in Delaware.
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.
The combination is also designed to reduce the risk of resistance developed by the Covid-19 virus.
The Company has received support $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), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.
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 in approximately 1,100 participants.
AstraZeneca is planning additional trials to evaluate AZD7442 in approximately 4,000 patients for the treatment of COVID-19.
AstraZeneca plans to supply up to 100,000 doses starting towards the end of 2020 and the US Government can acquire up to an additional one million doses in 2021 under a separate agreement.
Pascal Soriot, CEO, said: “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.”
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 prior to exposure to the virus.
A LAAB combination could be complementary to vaccines 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.
The agreement builds on previous funding of more than $25 million from US government agencies BARDA and the Defense Advanced Research Projects Agency for the discovery and evaluation of the monoclonal antibodies, as well as the Phase I clinical trial started in August 2020 to assess AZD7442 in healthy individuals.
The agreement is not anticipated to impact the company’s financial guidance for 2020 as the US Government funding is being offset by expenses to progress the clinical trials of AZD7442 as well as manufacturing process and upscaling costs.
Should the Phase III trials prove successful and AZD7442 become an approved medicine, the company anticipates providing the medicine at commercial terms during and after the current coronavirus pandemic.
AZD7442 is a combination of two LAABs derived from convalescent patients after SARS-CoV-2 infection. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June.
AstraZeneca is also working with Oxford University on a Covid-19 vaccine. The vaccine has been undergoing Stage 3 trials outside the U.S. after a brief pause after an illness was reported in a patient. The U.S. Food and Drug Administration has paused the trial in the U.S. while it investigates.
