AstraZeneca launches new antibody cocktail Covid-19 prevention studies – PharmaLive

AstraZeneca initiates new antibody cocktail COVID-19 prevention studies

LONDON (Reuters) – AstraZenecaAZN.L began late-stage trials of an experimental long-acting monoclonal antibody combination drug that it hopes could be used as a so-called prophylactic to prevent COVID-19 infection in people. at risk up to 12 months.

The Phase III international clinical trial will recruit a total of 5,000 people across countries in Europe and the United States to evaluate the safety and efficacy of the antibody cocktail, known as AZD7442.

Prophylactic treatment differs from a vaccine in that it introduces antibodies, rather than prompting the body’s immune system to produce them. It can be useful in people whose immune systems are weaker or compromised and who do not respond to vaccination. Separately, AstraZeneca is developing a COVID-19 vaccine in collaboration with researchers from the University of Oxford.

In Britain, where trials of the monoclonal antibody combination began on Saturday, 1,000 participants will be recruited at nine sites, researchers leading the British arm said.

“What we are investigating in this study is whether we can provide protection by providing antibodies that have been shown to neutralize the virus, by injection into the muscle,” said Andrew Ustianowski, professor and lead investigator of the UK study.

“The hope is that this will provide good protection for many months against infection.”

Monoclonal antibodies mimic the natural antibodies the body generates to fight infections. They can be synthesized in the laboratory and are already used to treat some types of cancer.

AstraZeneca said its COVID-19 cocktail – which combines two monoclonal antibodies – has the potential to both treat and prevent disease progression in patients already infected with the SARS-CoV-2 virus, and to be given as a preventive drug before of people such as health workers are exposed to the virus.

“These were specifically designed to have what we call a long half-life, (so) we think they will confer protection for (at least) six, but more likely closer to 12 months,” Mene Pangalos, executive vice president of AstraZeneca biopharmaceutical R&D, said. to reporters in a briefing.

He said this made the cocktail, “in effect, almost like a passive vaccination.”

In addition to the 5,000-participant study evaluating the drug’s potential as a preventive, AstraZeneca also plans to evaluate AZD7442 as a preventive and post-exposure preventive treatment in approximately 1,100 study participants in Europe and the United States.

Last month the US government awarded AstraZeneca $ 486 million to develop and secure supplies of up to 100,000 doses of the COVID-19 cocktail.

The UK government also has a principle agreement with AstraZeneca which says it grants access to one million doses of AZD7442 if successful in Phase III trials.

As part of a plan to create a global manufacturing network, Astra in October enlisted contract manufacturer Lonza LONN.S to manufacture the drug in Portsmouth, New Hampshire, beginning in the first half of 2021.

Reuters Source:

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-antibo/astrazeneca-starts-new-covid-19-prevention-trials-of-antibody-cocktail-idUSKBN281003