In the Covid-19 pandemic, the UK is officially the worst-hit country in Europe. According to the latest government figures, over 219,000 people have tested positive for the viral disease and slightly more than 31,000 of those have sadly died. Although the UK Government’s response to the pandemic has been criticised – particularly over sufficient provision of necessary personal protective equipment for frontline healthcare workers – it has sought to look beyond just the short-term impact of this pandemic.
Instead, a core priority of the UK Government and its healthcare agencies has been supporting the clinical development of potential treatment options to tackle this viral disease.
This has come in the form of funding commitments to international agencies – CEPI, the GAVI vaccine alliance, and contributing to an EC-led $8bn investment pledge – as well as attempting to leverage the UK’s strong track-record in life sciences research to combat Covid-19. Taskforces for both therapies and vaccines have been set up by the government to coordinate research and development efforts.
A recent example of the Therapeutics Taskforce in action is the launch of the Accelerating COVID-19 Research & Development (ACCORD) study platform to fast-track promising drugs through early clinical development and into the UK’s large-scale studies, such as the RECOVERY trial, the world’s largest Covid-19 study.
What is the UK’s Covid-19 ACCORD programme?
“Through ACCORD, we are bringing together the government, industry and research organisations to speed up the development of effective new coronavirus treatments, helping to save thousands of people’s lives and benefiting our NHS,” said Secretary of State for Business, Energy and Industrial Strategy Alok Sharma.
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The initiative is being funded by the Department of Health and Social Care (DHSC) and UK Research and Innovation (UKRI), but delivered through the National Institutes of Research and its associated expert centres, and furthered supported by AstraZeneca as an industry representative.
“Bringing together expertise from across the UK’s world-class research and innovation sectors – from clinical researchers through to the pharmaceutical industry – this national platform will rapidly prioritise and deliver the best potential drugs into clinical trials to discover if they can help people with Covid-19,” noted UKRI chief executive Professor Sir Mark Walport.
It is hoped this collaborative approach will reduce the time it takes to set up clinical studies from months to just weeks; the ultimate aim is to reduce the timeline even further.
Initially, six drugs have been chosen to be studied on the platform; these include both novel compounds and those being repurposed from other conditions. The Phase II, adaptive clinical trial platform has been provided by clinical research company IQVIA as it facilitates the conduct of multiple studies from different sponsors.
The government has only publicly declared the name of one the six therapies – BerGenBio’s investigational drug bemcentinib. However, AstraZeneca noted in a press release that two of its molecules are being explored: its Bruton’s tyrosine kinase inhibitor approved for blood cancers, Calquence, and an interleukin 33 drug candidate being studied in Phase II for another indication.
Pharma companies will be able to suggest to the Therapeutics Taskforce other promising drugs to be trialled using ACCORD.
Spotlight on BerGenBio’s bemcentinib
The first drug to be fast-tracked through the ACCORD programme is BerGenBio’s bemcentinib. It is a potent selective inhibitor of the AXL kinase, a protein “used by cells to allow them to change shape and move around”, explains Mewburn Ellis partner and patent attorney Rob Andrews, who has been advising BerGenBio for almost a decade.
This drug was initially developed by the British-Norwegian biopharma company to treat cancer because by inhibiting AXL kinase it can help stop cancer metastasising in the body. However, research has shown that AXL kinase also helps viruses infect the host’s cells, so “it turns out if you use bemcentinib to inhibit its target protein, then viruses find it more difficult to get into your cells”, Andrews says. This is because inhibiting AXL kinase activity blocks viral entry and enhances a key cellular defence mechanism against viral infection.
“Based on the fact that bemcentinib has been shown to work with some other viruses [including Ebola and Zika], BerGenBio did some preliminary, pre-clinical checks and they found that, indeed, it does reduce the rate at which coronaviruses could infect cells,” says Andrews. “That holds out the possibility that it might also work to prevent or treat Covid-19.”
Importantly, bemcentinib is a good candidate against Covid-19 because unlike most drugs being studied for this indication, which mainly focus on the severe end of the disease’s spectrum, it is applicable across the board.
“Because of its mechanism, it could potentially be used to prevent people getting Covid-19 in the first place as you can prevent that initial infection,” Andrews explains. “Also, if you’ve got someone who’s already suffering from Covid-19, in principle, you could give them bemcentinib to reduce the progression and symptoms of the disease.”
Andrews concludes: “If our aim is to reduce the burden on the NHS, you either want to stop people catching Covid-19 in the first place, or you want to make sure the people who have it do not end up needing intensive care or ventilators; bemcentinib could essentially work on both of those aspects.”
This drug also has a very favourable safety profile in adults, because the protein it inhibits becomes less essential in adulthood – it is more closely linked to a baby’s development in the womb. Its profile is well known because BerGenBio has been studying this drug for several years in oncology indications. This also allows the company to hit the ground running when it comes to testing it against Covid-19.
A final reason why Andrews thinks BerGenBio was an attractive first entrant into the ACCORD programme is because the company is “well plugged into the UK science scene” through existing partnerships and agreements within the country, as well as its research facilities in Oxford.
Pros and cons to pharma of engaging with ACCORD
“There is a huge PR and publicity advantage in pharma companies showing they are interested in society and are publicly-minded” by taking part in the ACCORD programme, notes Andrews.
In addition, there are scientific and technical benefits of being involved since “the UK Government is cutting a lot of red tape for these trials,” meaning “by taking part in an accelerated testing programme such as ACCORD might mean a company like BerGenBio could save months, if not years, of testing and finding patients” to recruit into studies.
However, Andrews notes this “PR sword can cut both ways; if you join in and don’t give the government what they ask for, that can reflect badly on you, particularly given the bad reputation of the pharma industry in some circles.”
There are also concerns among pharma companies with the loss of control over studies featuring their product, particularly as the ultimate aim of ACCORD is for these drugs to progress into the UK’s existing large-scale studies. Andrews notes: “One of the reasons why it is difficult to find patients for clinical trials is companies want to assess the patients carefully to make sure they’re from the group that are expected to benefit most from the drug.”
He continues: “When the firm doesn’t have that control, the patient group may not be so well suited to the drug. At best, the drug may be ineffective, at worst there could be a side effect linked with the drug when it is used in patients the company never would have selected for treatment. Identifying such a side effect could have a negative impact on the progress of a drug and, therefore the company’s value and/or share price.”
Ultimately, Andrews is optimistic that the benefits of participating in a programme like ACCORD outweigh these concerns, and concludes that “in practice pharma companies don’t have much choice” but to cooperate with these initiatives.