Pharmaceutical giant AstraZeneca is now injecting volunteers with its new antibody treatment for Covid-19 in a bid to see if it will protect people and also help already sick patients.
The British company, which also makes an experimental jab developed by experts at the University of Oxford, is hoping monoclonal antibody therapy will prove to be a breakthrough against coronaviruses.
The treatment works by pumping antibodies – natural virus-fighting molecules – into people who don’t have theirs.
These antibodies are taken from patients who have already had the disease and have produced the right substances to repel it.
If AstraZeneca’s therapy works, it could be a way to equip people’s immune systems to fight the coronavirus, even if they’ve never had it.
The £ 114 billion company confirmed today that the treatment has now started human trials in a group of 48 adult UK volunteers.
Pharmaceutical company AstraZeneca is testing treatment based on cloned antibodies from the immune system of people who have already recovered from Covid-19
The AstraZeneca treatment – currently known as AZD7442 – is a combination of two monoclonal antibodies.
Antibodies are substances produced and stored by the immune system to fight against an invader, such as the coronavirus.
The presence of a specific type of antibody in a person’s blood – for Covid-19, for example – usually indicates that someone has had an illness before.
Sometimes this means that patients are unlikely to contract it again, but it is not known if this is the case with the SARS-CoV-2 virus.
Monoclonal antibody therapy works by harvesting these antibodies from people who have previously had coronavirus and cloning them in a lab.
The cloned antibodies are then put into a solution and injected into a patient who has not had Covid-19, to strengthen their immune system.
It strengthens the immune system because the therapy means that if someone is exposed to the virus or has already caught it, their body is effectively given a lot of extra soldiers to fight it off.
The coronavirus-specific antibodies were discovered by Vanderbilt University in Nashville, Tennessee, and then shared with AstraZeneca in June.
The company then engineered the suit genetically so that it “offers at least six months of protection against Covid-19”.
AstraZeneca’s trial, involving healthy volunteers between the ages of 18 and 55, will look at the safety of the treatment, as well as the body’s reaction to the drug and how it treats it.
He hailed the move as an “important step” and said the drug has the potential to both protect uninfected people and help those already sick.
The treatment is different from a vaccine because it does not cause the body to develop immunity to the disease.
Vaccines usually inject a part of the virus into a person so that their body can learn to fight it in a safe environment by being exposed to it for real. Antibody treatment would be limited and would not cause the body to make more of its own antibodies.
Monoclonal antibody therapy works by injecting a person with antibodies that bind to the coronavirus and prevent it from attaching to cells in the body
Mene Pangalos, vice president of research and development for the company, said: “This trial is an important step in the development of our combination of monoclonal antibodies to prevent or treat Covid-19.
“This combination of antibodies, together with our proprietary half-life extension technology, has the potential to improve both efficacy and durability of use, in addition to reducing the likelihood of viral resistance. “
COVID-19 TREATMENT TRIAL FOR DIABETES PATIENTS TO BEGIN THIS WEEK
Possible treatment for patients with Covid-19 diabetes will begin human trials in the UK this week.
Excalibur Healthcare Services will begin testing a drug made by AstraZeneca called AZD1656 to see if it can reduce the risk of serious illness or death for people with diabetes who catch coronavirus.
People with diabetes are at a considerably higher risk of dying if they catch Covid-19 and, in May, a third of all coronavirus deaths were in people living with the disease.
Studies suggest that people with type 1 diabetes have a more than three times higher risk of death from Covid-19 than a healthy person, and those with type 2 diabetes are twice as likely to die , according to the NHS.
The trial of Excalibur, a type of medicine called a glucokinase activator, which helps regulate blood sugar, will try to stop people’s immune systems from overreacting to the coronavirus, which can be fatal.
The drug will be tested on coronavirus patients in UK hospitals who show “mild to moderate” symptoms.
If that works, the company has suggested the drug could be prescribed by a general practitioner for people with diabetes who show early symptoms of Covid-19.
The ARCADIA trial has received approval from the Government’s Medicines and Health Products Regulatory Agency (MHRA).
If the initial trial is successful – that is, the drug appears safe and effective – the company plans to move to larger phase two and three human trials.
The trial is funded by the US Defense Advanced Research Projects Agency and the Biomedical Advanced Research and Development Authority, part of the US Department of Health and Human Services.
AstraZeneca is not the first company to develop monoclonal antibody therapy and the pharmaceutical company Eli Lilly & Co is already testing its own therapy in the United States.
Indiana-based Eli Lilly is currently testing two types of antibody therapy, which work by sticking and blocking “spike proteins” on the surface of the coronavirus, which are what he uses to cling to cells. human.
This effectively neutralizes the SARS-CoV-2 virus – which causes Covid-19 – preventing it from attaching itself inside the airways and infecting people.
Dr Daniel Skovronsky, chief scientist of the $ 144 billion company, said if the trials go well, the treatments could be ready by fall.
“For the indication of treatment, in particular, it could go quite quickly,” he told Reuters.
“If in August or September we see that treated people do not progress to hospitalization, that would be powerful data and could lead to emergency use authorization. “
“So that puts you in the fall: September, October, November is not unreasonable,” he said.
AstraZeneca’s announcement comes after the company yesterday rejected claims the United States was trying to strike a deal to gain access to its Covid-19 vaccine before clinical trials were completed.
The company has issued a denial as Donald Trump wanted to get the coup approved ahead of this fall’s presidential election.
White House insiders have claimed that the US president is planning to speed up regulatory approval of the jab, originally developed by scientists at the University of Oxford.
Commissioning of a vaccine and slowing the devastating US coronavirus crisis – the world’s worst – could increase Trump’s chances of being re-elected in November, when he runs against Democratic candidate Joe Biden, who accused him of ‘failing to protect’ us’.
But AstraZeneca, which oversees the manufacture and distribution of the jab, said it had not entered into discussions to obtain emergency use authorization in the United States. He added that it would be “premature to speculate on this possibility”.
A company spokesperson said, “AstraZeneca has not discussed emergency use authorization with the US government and it would be premature to speculate on this possibility.
“Late Phase II / III trials for AZD1222 are underway in the UK and other markets around the world, and we don’t expect efficacy results until later this year.
Number 10 insisted yesterday that Britain would be the first to receive the Covid-19 vaccine, if it turns out to work.
The UK has already purchased 100 million doses of the jab, while the US has ordered 300 million.
The first trials have shown promising results, with tests showing that the vaccine is safe to use in humans and appears to elicit an immune response.
But the data that proves it protects people is not expected until later this year.
WHAT IS MONOCLONAL ANTIBODY THERAPY?
Monoclonal antibody therapy is a form of immunotherapy that uses monoclonal antibodies (mAbs).
It is given by injection under the skin or by drip into a vein.
The treatment works in different ways. It can work like a vaccine, protecting a patient from serious illness or can help stimulate the patient’s immune system to attack the antigens.
Hybridoma technology is a method of producing a large number of monoclonal antibodies – identical antibodies that are clones of a single mother cell.
The process begins by injecting an animal, such as a mouse, with an antigen that elicits an immune response.
B cells produce antibodies that bind to the antigen. These antibody-producing B cells are then harvested and used to grow more antibodies.
Monoclonal antibodies are screened against their ability to act, with initial animal experiments.
Major technological advancements have made the discovery and development of mAb therapies faster and more effective, deriving antibodies from humans and not from animals.
Scientists can create a mAb specific for almost any antigens and are working on one for the coronavirus.
The spike protein on the SARS-CoV-2 virus is the main target explored for potential Covid-19 monoclonal antibodies.
The goal is that by targeting the spike protein, the antibody can neutralize the SARS-CoV-2 virus, thus preventing it from infecting healthy cells.
One particularly interesting avenue is to give them to people who are not yet infected as a prevention tool. If the antibodies are strong enough and long-lasting enough, they could provide enough protection for some time before a vaccine is found.
Research and development is underway to create antibodies against diseases such as rheumatoid arthritis, multiple sclerosis, Alzheimer’s disease, and different types of cancers.
But many are already in use in the US and UK.
Since 2008, 48 new mAbs have been approved, contributing to a total global market of 61 mAbs in clinical use at the end of 2017, according to the US FDA.