Experimental cancer drug is fast-tracked into human coronavirus trials

Bemcentinib, an experimental Norwegian cancer drug has become the first to be fast-tracked into UK Government-funded coronavirus trials

An experimental Norwegian cancer drug has become the first of six promising coronavirus treatments to be fast-tracked into human coronavirus trials in the UK.

The medication, called bemcentinib, could be tested on 120 hospitalised COVID-19 sufferers at six NHS trusts as early as this week.

Laboratory studies by the University of Iowa found the pill could boost immune response and switch off AXL receptors, which when turned on, allow the virus to enter and multiply in lung cells.

BerGenBio said its drug – which had shown promising results in trials on cancer patients – was ‘special’ because it is taken as a once-a-day pill and has few side effects.

The small Bergen-based biotech firm said this made it suitable for elderly and fragile people prone to developing severe illness. 

Bemcentinib, along with five other promising drugs, has been selected as part of the Government’s ACCORD programme to find a cure for the virus.

The Department of Health revealed two of the others being looked at are MEDI3506 and acalabrutinib. But officials told MailOnline they were not naming the other three.  

MEDI3506 is found in Farxiga, which can help treat chronic obstructive pulmonary disease (COPD) and diabetic kidney disease.

Calquence, generic name acalabrutinib, is a medication for a type of non-Hodgkin lymphoma known as mantle cell lymphoma. 

Bemcentinib is believed to work by inhibiting the AXL receptor, thought to be coronavirus' doorway into cells

Bemcentinib is believed to work by inhibiting the AXL receptor, thought to be coronavirus’ doorway into cells

Bemcentinib will be rushed into the phase 2 trial this week or next, and results are expected within months.

Phase 2 studies focus on the testing of a drug on patients to assess how effective it is, while working out its side effects. 

If it is found to treat coronavirus patients it will be rushed into large-scale phase three trials on thousands of patients.

Bemcentinib is believed to work by inhibiting AXL receptors, which regulate immune cells, according to lab studies at the University of Iowa.

The number of AXL receptors increases when their environment is stressed, particularly when viruses or cancers start multiplying in the body.

When AXL receptors are hijacked by invading viruses, the cell’s antiviral powers are switched off and it becomes defenceless to the disease.

The test tube studies also showed the drug enhanced a type I interferon response, which alerts the body to the coronavirus and calls for more immune cells to attack it.

Bemcentinib is currently being trialled on around 300 cancer patients, but it is not approved as a treatment in any country.

Given at the same time as chemotherapy, it has been shown to boost the immune response to cancer, prevent drug resistance and slow down the spread of tumours.

Calquence is also being studied

The Department of Health revealed two of the others being looked at are MEDI3506, found in Forxiga

The Department of Health revealed two of the others being looked at are MEDI3506, found in Forxiga (right), and acalabrutinib, branded as Calquence (left)

Richard Godfrey, chief executive of BerGenBio, said: ‘We are delighted to be part of this initiative which is a ground-breaking partnership between government, academia and industry.

‘We are hopeful that bemcentinib can play a significant role in the global effort to find suitable treatment options for COVID-19 patients, which has had such serious implications for so many people and thereby ease pressures on hospital intensive care units, and ultimately treat thousands of patients.

‘We are poised to commence dosing in the coming days and will provide results as soon as is practically possible.’

Health Secretary Matt Hancock said: ‘Currently no drugs in the world have been clinically proven to treat Covid-19. But our Therapeutics Taskforce has identified a number of promising candidates.

WHAT ARE THE THREE MAIN CORONAVIRUS TRIALS IN THE UK?

Principle 

The Principle trial is studying people aged 50 to 64 who have COVID-19 symptoms and a chronic health condition such as heart disease, asthma or cancer. 

It is unclear how many patients are taking part. 

It is also open to those aged 65 or over, with or without other illnesses.

The first drug that will be trialled is hydroxychloroquine, sold as Plaquenil. Other potential treatments will be used if they show promise in pre-clinical studies.

The study is being run at the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) in Surrey.

It will last until March next year.

Recovery

The Randomised Evaluation of COV-id19 thERapY (RECOVERY) trial is being run by the University of Oxford. 

It will test the HIV drug lopinavir/ritonavir, marketed as Kaletra and Aluvia, hydroxychloroquine, a malaria medication sold as Plaquenil, and dexamethasone, a type of steroid use in a range of conditions to reduce inflammation.

Almost 1,000 patients from 132 different hospitals have been already recruited in just 15 days.

Thousands more are expected to join the trial in the coming weeks, making it the largest randomised controlled trial of potential COVID-19 treatments in the world.

Definitive results on whether the treatments are safe and effective are expected within months and, if positive, they could potentially benefit hundreds of thousands of people worldwide. 

REMAP-CAP

The REMAP-CAP trial is an international effort, with more than 50 research teams around the world taking part. 

It is looking specifically at patients who develop community-acquired pneumonia (CAP) as a result of viral infections.   

The study will test 16 drugs, including  hydroxychloroquine, lopinavir/ritonavir and interferon beta, which have all shown promise in pre-clinical trials.

Between 2,000 and 4,000 patients will be enrolled.

‘Currently, six different treatments have been entered into national clinical trials and the first is ready to enter the next stage: a new early phase clinical trial platform that we are launching today. This is a national effort made possible by government, academia and industry working together.’

Funded by the DOH and UK Research and Innovation, the ACCORD (Accelerating COVID-19 Research & Development platform) trial aims to get an early indication of drug treatments’ effectiveness in treating coronavirus.

The ‘rapidly’ scaled-up national initiative will accelerate the development of new drugs for patients hospitalised with the disease.

This will reduce the time taken to set up clinical studies for new therapies from months to just weeks, helping to ease pressure on the NHS.

Doctors are scrambling to find a treatment that can help cure or slow down the disease, which has killed more than 21,000 people in Britain.

Repurposing one which is already used to treat another illness would be the best way to do this because it saves time on clinical trials and licensing.

Further potential treatments will be rapidly fed into ACCORD as the programme rolls out over the next few weeks.

Early hopes for treatments included a lupus and rheumatoid arthritis drug called hydroxychloroquine and an antiviral designed for Ebola called remdesivir.

Trials on those two have so far returned mixed results but countries around the world continue to test them under the guidance of the World Health Organization.

Hydroxycholoroquine is being tested in the UK in three studies.

One is a study being run by the Royal College of General Practitioners for patients aged over 50 who develop COVID-19 symptoms.

It is being done on an unknown number of people, of whom the under-65s will all have to have a long-term health condition such as asthma or heart disease to qualify.

Another trial, named RECOVERY, will test hydroxychloroquine as well as others such as the HIV drug lopinavir/ritonavir, and a steroid called dexamethasone, on thousands of patients from more than 100 different NHS hospitals.

The RECOVERY trial, run by the University of Oxford, is the UK’s largest so far and results could be returned within months.

Britain’s third main trial, named REMAP-CAP, is part of an international effort which will study people who develop pneumonia after catching the coronavirus. It will test 16 drugs on those patients, among them hydroxychloroquine and lopinavir/ritonavir.

Another clinical trial being done in NHS hospitals is not testing medication, per se, but examining whether COVID-19 patients could benefit from being injected with immune cells taken from patients who have already recovered from the virus.

The blood plasma therapy trial is being carried out with the help of the NHS Blood & Transplant service and involves collecting immune cells from people who have recovered, and making a sterilised treatment to give to people who are currently ill.

The treatment, known as convalescent plasma, has been around in principle for over 100 years and may work by boosting the patient’s immune system.

A drug designed to battle Ebola, called remdesivir, had been slated as a promising option but was last week reported to have failed its first clinical trial in China. Results for patients taking it appear to be mixed.

Documents published by accident by the World Health Organization suggested the trial had not worked just days after one in Chicago said it eased patients’ symptoms and helped them to leave hospital sooner.

Trials in the UK were announced by the manufacturer, Gilead, at the start of this month and are taking place across 15 medical clinics in the UK.

In another announcement about medications today, Mr Hancock said the Government would relax the laws on medicine-sharing in care homes.

He said staff in nursing and residential homes would now be able to use spare drugs prescribed to treat a resident for whom they were not initially prescribed in certain circumstances, if they were otherwise going to be thrown away.

He said this would help the homes ‘make best possible use’ of drug supplies.

Mr Hancock also announced that routine coronavirus swab testing will now be available for everyone working or living in a care home or hospital, regardless of whether they have symptoms of COVID-19.

And tests will also be available to anyone over the age of 65 who has a high temperature or a new cough, and to people who live with them.

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