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 patients who are already ill.
The British company, which is also manufacturing an experimental jab developed by experts at Oxford University, hope the monoclonal antibody therapy will prove to be a coronavirus breakthrough.
The treatment works by pumping antibodies — natural virus-fighting molecules — into people who don’t have their own.
These antibodies are harvested from patients who have already had the disease and produced the right substances to fend it off.
If AstraZeneca’s therapy works it could be a way to equip people’s immune systems to fight the coronavirus, even if they have never had it.
The firm, worth £114billion, today confirmed the treatment has now started human trials in a group of 48 adult volunteers in the UK.
The pharmaceutical company AstraZeneca is trialling a treatment based on cloned immune system antibodies from people who have already recovered from Covid-19
AstraZeneca’s treatment — known currently as AZD7442 — is a combination of two monoclonal antibodies.
Antibodies are substances produced and stored by the immune system to tackle an invader, such as the coronavirus.
The presence of a specific type of antibody in someone’s blood — for Covid-19, for example — usually indicates someone has already had a disease.
Sometimes it means the patients are unlikely to get it again, but it is not clear if this is the case for the SARS-CoV-2 virus.
Monoclonal antibody therapy works by harvesting these antibodies from people who have already 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 boost their immune system.
It boosts the immune system because the therapy means that if someone is exposed to the virus or has already caught it, their body effectively receives a batch 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 firm then genetically engineered the combination so that they ‘afford at least six months of protection from Covid-19’.
AstraZeneca’s trial, involving healthy volunteers aged 18 to 55, will look at the safety of the treatment, as well as the body’s reaction to the drug and how it processes it.
It hailed the move an ‘important milestone’ and claimed the drug has the potential to both protect uninfected people and to help people who are already sick.
The treatment is different to a vaccine because it does not train the body to develop immunity against the illness.
Vaccines usually inject someone with a part of the virus so their body can learn how to fight it in a safe environment by being exposed to it for real. The antibody therapy would be limited and would not lead to the body making more of its own antibodies.
Monoclonal antibody therapy works by injecting a person with antibodies which bind onto the coronavirus and stop it being able to latch onto cells in the body
Mene Pangalos, vice-president of research and development at the firm, said: ‘This trial is an important milestone in the development of our monoclonal antibody combination to prevent or treat Covid-19.
‘This combination of antibodies, coupled to our proprietary half-life extension technology, has the potential to improve both the effectiveness and durability of use, in addition to reducing the likelihood of viral resistance.’
COVID-19 TREATMENT TRIAL FOR DIABETES PATIENTS TO BEGIN THIS WEEK
A possible treatment for Covid-19 patients with diabetes will begin human trials in the UK this week.
The company Excalibur Healthcare Services will begin tests of an AstraZeneca-made drug called AZD1656 to see if it can reduce the risk of serious illness or death for people with diabetes who catch coronavirus.
Diabetics face a considerably higher risk of dying if they catch Covid-19 and, by May, a third of all coronavirus deaths had been in people living with the illness.
Studies suggest that people with type 1 diabetes have a more than three times higher risk of death with Covid-19 than a healthy person, and those with type 2 diabetes are twice as likely to die, according to the NHS.
Excalibur’s trial, of a type of drug called a glucokinase activator, which helps to regulate blood sugar, will try to prevent people’s immune systems from over-reacting to coronavirus, which can be deadly.
The drug will be trialled on coronavirus patients in UK hospitals who have ‘mild to moderate’ symptoms.
If it works the company suggested the drug could be prescribed by a GP to diabetic people who have early symptoms of Covid-19.
The ARCADIA trial has received approval from the governmental Medicines and Healthcare products Regulatory Agency (MHRA).
If the initial trial is successful — that is, the drug appears to be safe and effective — the company plans to move on to larger phase two and three human trials.
The trial is being funded by the US Defence Advanced Research Projects Agency and the Biomedical Advanced Research and Development Authority, which is part of the US Department of Health and Human Services.
AstraZeneca is not the first company to develop a monoclonal antibody treatment and pharmaceutical firm Eli Lilly & Co is already trialling its own therapy in the US.
Eli Lilly, based in Indiana, is currently trialling two types of antibody therapy, which work by sticking onto and blocking the ‘spike proteins’ on the surface of the coronavirus, which are what it uses to latch onto human cells.
This effectively neuters the SARS-CoV-2 virus – which causes Covid-19 – stopping it from attaching to the insides of the airways and infecting people.
Dr Daniel Skovronsky, chief scientific officer at the $144billion company, said if trials go well the treatments could be ready to go by the autumn.
‘For the treatment indication, particularly, this could go pretty fast,’ he told Reuters.
‘If in August or September we’re seeing the people who got treated are not progressing to hospitalization, that would be powerful data and could lead to emergency use authorization.’
‘So that puts you in the fall time: September, October, November is not unreasonable,’ he said.
AstraZeneca’s announcement comes after the company yesterday fended off claims that the US was trying to strike a deal to get access to its Covid-19 vaccine before clinical trials had finished.
The company issued a denial amid reports Donald Trump wants to get the jab approved before the presidential election this autumn.
White House insiders claimed the US President is considering speeding up regulatory approval for the jab, originally developed by Oxford University scientists.
Getting a vaccine into use and slowing down the US’s devastating coronavirus crisis — the worst in the world — could boost Trump’s chances of becoming re-elected in November, when he runs against Democratic candidate Joe Biden, who accused him of having ‘failed to protect us’.
But AstraZeneca, which oversees manufacturing and distribution of the jab, said it has not entered any talks about getting it an emergency use authorisation in the US. It added that it would be ‘premature to speculate on that possibility’.
A spokesperson for the firm said: ‘AstraZeneca has not discussed emergency use authorization with the US government and it would be premature to speculate on that possibility.
‘Late stage Phase II/III trials for AZD1222 are ongoing in the UK and other markets globally, and we do not anticipate efficacy results until later this year.’
Number 10 yesterday insisted Britain will be the first to get the Covid-19 vaccine, if it is proven to work.
The UK has already bought 100million doses of the jab, while the US has ordered 300million.
Early trials have shown promising results, with tests showing the vaccine is safe to use in humans and appears to provoke an immune response.
But 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 (mAb).
It’s given as an injection under the skin or through a drip into a vein.
The treatment works in many different ways. It can work in a vaccine-like way, protecting a patient from severe disease, or can help to stimulate the patient’s immune system to attack antigens.
Hybridoma technology is one method for producing large numbers of monoclonal antibodies – identical antibodies that are clones of a unique parent cell.
The process starts by injecting an animal, such as a mouse, with an antigen that provokes an immune response.
B cells produces antibodies that bind to the antigen. These antibody producing B-cells are then harvested and used to culture more antibodies.
The monoclonal antibodies are screened against their ability to work, with initial experiments in animals.
Major technological advances have made the discovery and development of mAb therapies quicker and more efficient, deriving the antibodies from humans and not animals.
Scientists can create a mAb that is specific to almost any antigen, and are working on one for the coronavirus.
The spike protein on the SARS-CoV-2 virus is the primary target being explored for potential Covid-19 monoclonal antibodies.
The aim is that by targeting the spike protein, the antibody will be able to neutralise the SARS-CoV-2 virus, therefore stopping it from infecting healthy cells.
A particularly interesting avenue is giving them to people who aren’t infected yet as a preventative tool. If the antibodies are potent and long-lasting enough, they could provide sufficient protection for a period of time before a vaccine is found.
Research and development is underway to create antibodies for diseases such as rheumatoid arthritis, multiple sclerosis, Alzheimer’s disease, and different types of cancers.
But many are already in use both 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.