Trump administration funding Phase 3 studies on AZ monoclonal antibody therapy
The Biomedical Advanced Research and Development Authority (BARDA) and the DoD, as part of Operation Warp Speed, announced an agreement on Friday [October 9] with AZ for late-stage development and large-scale manufacturing of the product, a cocktail of two monoclonal antibodies.
AZ will receive around US$486m for two Phase 3 clinical trials and related development activities, including a large-scale manufacturing demonstration project and supply of AZD7442 doses in the US.
This latest agreement builds on previous funding of over $25m from BARDA and the DoD for the therapy.
An effective monoclonal antibody, particularly one that is long-lasting and delivered by intramuscular injection, may be of particular use in certain groups including people who have compromised immune function, those who are over 80 years old, and people undergoing medical treatments that preclude them from receiving a COVID-19 vaccine.
Vanderbilt university led innovation
AZD7442 is a combination of two LAABs derived from convalescent patients after SARS-CoV-2 infection. It was discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.
AZ's LAABs have been engineered with the company's proprietary half-life extension technology, which the pharma giant says increases the durability of the therapy for six to 12 months following a single administration.
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.
Phase 3 clinical studies
AZ said the Phase 3 trials on AZD7442 are due to begin in the next weeks.
One of those studies will evaluate the safety and efficacy of the product to prevent infection for up to 12 months in 5,000 volunteers. A second Phase 3 clinical study will evaluate if the LAABs can help prevent infection in people who have come in contact with someone with COVID-19 in a post-exposure prophylaxis setting; that study will have a cohort of 1,100.
AZ plans to supply up to 100,000 doses starting towards the end of 2020; it said the US government can acquire up to one million more doses in 2021 under a separate agreement.
Monoclonal antibodies making a lot of noise
Products based on monoclonal antibodies (mAb) have been grabbing a lot of headlines of late in relation to COVID-19 treatment; last week saw Regeneron submit a request for Emergency Use Authorization (EUA) to the FDA for its REGN-COV2 investigational antibody combination for COVID-19 which was given to US President Donald Trump, as part of his treatment.
The biotech’s combination of two monoclonal antibodies has been designed to block infectivity of SARS-CoV-2. The company said it has doses available for around 50,000 patients at this time, with the ability to scale this up to 300,000 within the coming months.
Regeneron is already part of Operation Warp Speed, having announced a $450m manufacturing and supply agreement with BARDA and the DoD for the antibody cocktail in July.
Eli Lilly also announced last week that it has submitted an initial request for EUA to the FDA for its LY-CoV555 monotherapy, a neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19.
