Hospital staff could be carrying SARS-CoV-2, the coronavirus that causes COVID-19 disease, without realising they are infected, according to a study by Cambridge University researchers.

Patients admitted to NHS hospitals are now routinely screened for the SARS-CoV-2 virus and isolated if necessary. But NHS workers, including patient-facing staff on the front line, such as doctors, nurses and physiotherapists, are tested and excluded from work only if they develop symptoms of the illness. 

Many of them, however, may show no symptoms at all even if infected, as a new study published in the journal eLife demonstrates.

The Cambridge team pro-actively swabbed and tested over 1,200 NHS staff at Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, throughout April. 

The samples were analysed using a technique called PCR to copy and read the genetic information of material present on the swab, producing a colour change whenever the coronavirus was present in a specimen. At the same time, staff members were asked about relevant coronavirus symptoms.

Of the more than 1,000 staff members reporting fit for duty during the study period, three per cent nevertheless tested positive for the coronavirus. 

On closer questioning, around one in five reported no symptoms, two in five had very mild symptoms that they had dismissed as inconsequential and a further two in five reported COVID-19 symptoms that had stopped more than a week previously.

To probe routes of possible transmission of the virus through the hospital and among staff, the researchers also looked at whether rates of infection were greater among staff working in ‘red’ areas of the hospital, those areas caring for COVID-19 patients. 

Despite wearing appropriate personal protective equipment, red area staff were three times more likely to tested positive than staff working in COVID-19 free ‘green’ areas. 

It’s not clear whether this genuinely reflects greater rates of transmission from patients to staff in red areas. Staff may have instead transmitted the virus to each other or acquired it at home. 

Staff working in the red areas were also swabbed earlier in the study, closer to when the lockdown was first initiated, so the higher rates of infection in this group might just be a symptom of higher rates of virus circulating in the community at the time.

Nevertheless, extrapolating these results to the more than half a million patient-facing staff working across the NHS UK-wide suggests that as many as 15,000 workers may have been on duty and infected, with the potential to transmit the virus to co-workers, family members and patients, during the month of April. In fact, this figure could be even higher in settings where the supply of PPE has been very problematic.

The implications of the new study, say senior authors Dr Mike Weekes and Professor Stephen Baker from the Cambridge Institute of Therapeutic Immunology and Infectious Disease, are that hospitals need to be vigilant and introduce screening programmes across their workforces. 

“Test! Test! Test! And then test some more,” Dr Weekes exhorts. “All staff need to get tested regularly for COVID-19, regardless of whether they have any sort of symptoms – this will be vital to stop infection spreading within the hospital setting.”

Ruth Logan, head of assurance at EY in Cambridge, describes the challenges companies are facing in the current crisis and how they are responding with entrepreneurialism, planning and positivity. 

In business, cash is king. Businesses ultimately fail because they run out of cash, so even a profitable business can get into trouble if it has insufficient credit terms from suppliers or inadequate alternative funding for its working capital needs.

There is no doubt that businesses continue to face unprecedented challenges and are having to make very difficult decisions; including adapting or reducing their operations, temporarily ceasing to trade, or sadly closing altogether. 

For those able to revive their business, there will come a period of re-evaluation. Some will find the ‘new norm’ difficult to adjust to and some will struggle to pull through, but there will be others who have embraced the opportunities created by the crisis and will thrive. 

Opportunities for entrepreneurs and visionaries 

Responding quickly to the situation, business leaders with an entrepreneurial mindset shifted their operating models within days to adapt to the new world order. 

For example, manufacturers turned their skills and machinery to make ventilators and other essential medical support devices; restaurant owners devised intelligent ways to make home food deliveries; and media companies offered additional interactive home entertainment. 

Investing in a digital strategy before the crisis began, such as online communications, ordering or payments, is certainly proving its worth right now. 

The East of England is known for its diversity; it’s strength in technology, innovation and pharma industries, for its huge swathes of agricultural land and tourism on the coast. These industries have been some of the hardest hit by COVID-19 and the continued lockdown measures.  

Others, such as those working on supporting activities to find a vaccine for COVID-19 or providing solutions for shortages in respiratory support and PPE are busier than ever, bringing with it different challenges, such as ensuring employee health and wellbeing and supply and demand. 

It’s also been well reported that some businesses operating in rural locations and those involved in arable farming will face challenges associated with labour shortages, due to the closure of borders, at what is for many the peak of their season. 

Regardless of sector, COVID-19 is having a far-reaching impact on businesses. How they respond and, in some cases, recover will depend greatly on how they can adapt to these unprecedented challenges and perhaps access the financial support that is being offered by the UK Government and beyond.  

Welcomed government support

The 100 per cent guarantee scheme, which encourages banks to lend to struggling businesses, is a welcome introduction by the Government. In addition, businesses on the brink may be relieved to see that usual rules on wrongful trading of an insolvent business have been suspended, to allow directors to do everything they can to rescue their businesses without fear of exposure to personal liability. 

What will also help is the postponement of plans to establish HMRC as a secondary preferential creditor – in respect of certain taxes including: VAT, PAYE and employee NICs – from April to December 2020. 

This will give directors more time to understand and navigate the impact of the legislative changes on all creditors, especially if there is a strong chance the company may not emerge solvent from this crisis.

Strong sense of unity

We have already seen the level of pressure companies are facing, demonstrated by a sharp upturn in the number of profit warnings issued by listed businesses across the UK. 

Although, due to the business landscape, with fewer listed companies, the East of England has been largely sheltered. However it is in the region’s retail, hospitality and leisure sectors, particularly on easterly coastal areas where the impact will most keenly be felt. 

Although the impact is no doubt being felt throughout the economy, what is positive to see is the examples of how companies are adapting and acting to support their employees, supply chains and communities that will benefit now and in the future. 

Companies across the East of England have demonstrated incredible resilience in recent years and a strong sense of unity and belief that ‘we are in this together’ will help businesses to reshape and emerge from the crisis.

ey.com

The recent enforced changes in how we work as well as where we work raises questions as to how commercial office space will change in the future, writes Barnaby Clark, Sales and Marketing Director of office design and fit-out specialist, COEL.

A couple of things are evident: for some businesses working from home previously would not have been an option and yet the current lockdown will validate that many employees can work from home and indeed may prefer to. 

Conversely, the deluge of those signing up to Zoom and other communicative technology proves the basic need for most to feel the connectivity and vitality of team dynamics. 

These diverse themes compounded with the likely requirement to cut costs and safeguard employees from infection leads to the question of whether it is possible to create the ideal workplace for a changing world.

COEL recognises that the workplace can act as a facilitator for enhancing company culture and that employees flourish when their work environment is designed with their needs in mind. 

With regards to ongoing costs, a thoughtful design respecting the requirements of the individuals and offering diversity in the methods of working will pay you dividends.

A few years ago, COEL undertook a major project for Bidwells following the firm’s ambitious plan for its headquarters in Trumpington to become the first truly agile refurbished building in Cambridge. 

They wanted their staff to be rewarded on output and performance rather than traditional 9-5 attendance. Staff were given a Surface Pro laptop and a mobile phone each; giving them the option to work from home or from one of the many different work points. 

In the year after the refurbishment was completed Bidwells found they had made incredible economic and ecological savings as well as having significant improvement in staff retention and wellbeing:-

• Electricity costs per head in Bidwell House reduced by 27.5 per cent
• Water costs per head reduced by 31 per cent
• A reduced printing cost of 70 per cent
• A reduced stationary cost of 38 per cent
• Average employee satisfaction levels rose from 53 per cent in January 2018 to around 70 per cent from April 2018 after moving into the refurbished Bidwell House
• Significantly employee sick days have reduced by 23 per cent since adopting an agile way of working

At present we are project managing a scheme to merge the three floors a company presently occupy into one floor. The consolidation process must be done sympathetically and with a commitment to ensure that the workplace is not compromised and that the employees requirements are fulfilled.

Whilst there are clear economic benefits for our client, COEL gives precedence to designing a workplace which builds community, inspires and motivates staff whilst also putting a spotlight on employee health.
Protecting employees’ health and wellbeing will be a prime concern now more than ever. 

Home working has been a practical necessity in recent weeks however, the consequences of people feeling lonely and detached from others can result in a rise in mental health issues such as anxiety and depression. 

The workplace is more than the place people go to to and do their job it is a forum which provides potential connection and collaboration with others, routine, purpose, and a sense of being part of a team.

These are basic human needs that need addressing and in order to do so we must use spaces differently, be flexible and adapt to a changing world. With the benefit of modern technology and products, COEL can provide solutions to concerns, some of which are the following:-

• Provision of cycling racks to enable staff to cycle rather than get public transport
• Automatic doors installed at the building entrance to limit contact with surfaces
• For new building plans larger lift lobbies should be considered to enable fewer occupants on each lift trip
• Ensure there is easy access to stairs, and with multiple staircases having each allocated as ‘up’ or ‘down’ only
• Introduce ‘one directional’ routes around larger offices to help prevent frequent circulation crossovers when social distancing cannot be maintained
• Flooring details that remind staff of 2m distancing
• Signage details that provide reminders of expected distancing and protocols
• Levy a practice of keeping desks clear and as a result easier to clean 
• Privacy screens can be set up to protect workspaces

It will also be crucial to use materials in the design of the workspace which have anti-bacterial qualities and are easy to clean and maintain – such as wipeable wallpaper, anti-bacterial carpets and ceiling tiles.

Office space should become more streamlined and areas eliminated where bacteria and viruses could linger. We would also recommend reviewing air conditioning systems that are in place and updating rest rooms to provide touch-free door access and ensure the provision of correct supply and extract ventilation. 

It goes without saying that premises should provide hand sanitisers and hand washing facilities in obvious and accessible locations. Offices can also install touch free taps in the kitchens and bathrooms.

We suggest minimising the use of cupboards and instead have open units and shelves. Offices should ensure a regular cleaning rota and give staff access to antibacterial gel and sprays.

Importantly, companies should invest in smart technology – such as apps which can call for lifts and track occupancy for different areas of the building.

Plant wellbeing is another important consideration; by providing botanical displays employees benefit from the positive effects of being near nature and at the same time the plants will help purify the air.

COEL prioritises making working lives better and partnering with our clients to solve their workplace challenges. All businesses will be looking to invest in a sustainable future by safeguarding staff and at the same time meet their expectations of success. 

The current climate offers new challenges which the COEL team will continue to meet and provide positive solutions to. 

coel.co.uk

GW Pharmaceuticals plc, which is pioneering medicines based on cannabis, has scaled fresh heights in terms of financial performance and advancement of treatments in the US and Europe in the first quarter of 2020.

The Cambridge, UK headquartered business has turned its cannaboid-based medicines into a pot of gold in Q1, soaring to revenues of $120.6 million from $392m this time last year. At the same time GW has scythed losses from $50.1m in Q1 2019 to just $8m this time.

Despite investment in growth cash burn is more like a slight singe: cash and equivalents at March 31, 2020 were $500.9m compared to $536.9m at December 31.

The jewel in the crown is Epidiolex® for which net product sales scaled to $116.1m. 

CEO Justin Gover said: “In the first quarter of 2020 we have seen continued strength of the Epidiolex brand in both the US and Europe and remain confident about prospects for growth in the remainder of the year. 

“Having been granted priority review by the FDA for our proposed label expansion to include TSC, our US commercial team is actively preparing for the launch of this indication in August.”

Nasdaq-quoted GW had been granted Orphan Drug Designation from the FDA for Cannabidiol for the treatment of TSC (Tuberous Sclerosis Complex) a rare genetic disorder, the most common symptom of which is epilepsy. 

Epilepsy occurs in around 80-90 per cent of TSC patients and is a significant cause of morbidity and mortality.

Gover added: “In this current environment caused by COVID-19, we have been able to support the epilepsy community remotely and maintain production of Epidiolex, while taking necessary steps to maintain the wellbeing of our employees. 

“Looking ahead, GW is well placed to emerge strongly from the COVID-19 crisis with significant growth prospects for Epidiolex in the US and Europe, important pipeline clinical trials ready to execute, a strong balance sheet, and an unparalleled leading position in cannabinoid science.”

Three Cambridge technology innovators have had government support for ventilator designs in which they were instrumental terminated following a further review.

Cambridge Consultants, Sagentia and TTP were co-designers of their particular models but have now met the same fate as Team Consulting for whom financial support was ended in April.

The Cabinet Office confirmed that, following re-assessment from a panel of expert clinicians, the department was ending support for five deisngs which included Veloci-Vent, made by Cambridge Consultants Ltd and MetLase;
CoVent made by TTP and Dyson and the Sagentia Ventilator, made by Sagentia.

Director, Medical Devices Testing and Evaluation Centre, Dr Tom Clutton-Brock said: “All five designs have made exceptional progress since the start of the Ventilator Challenge, with a number of devices having been assessed as having viable designs by expert clinicians. 

“However they would require further development before they would be ready for clinical testing and they are not currently required to meet immediate demand. Companies may continue to develop their designs, including for CE-marking.”

Chancellor of the Duchy of Lancaster Michael Gove revealed that a batch of new ventilators under the Ventilator Challenge has arrived in the UK to continue supporting NHS patients with coronavirus: 150 devices, made up of the Vivo65 and the Nippy4+ ventilators from Breas Medical have arrived from Sweden.

The Government has ordered 2000 of the devices, with hundreds expected to arrive over the coming weeks.

Gove said: “The arrival of the Breas Medical devices further underlines the Ventilator Challenge’s success in stepping up the number of ventilators in the UK.

“These devices are well suited to helping patients in intensive care and will complement the two other Ventilator Challenge devices currently on the NHS frontline.

“We are also hugely grateful to those companies that will not be progressing further in the Ventilator Challenge. They can be proud of the part they played in the national effort to protect the NHS and save lives.”

The UK now has over 11,000 mechanical invasive ventilators available in total.

• PHOTOGRAPH: Chancellor of the Duchy of Lancaster Michael Gove – Crown Copyright.

It is perhaps unavoidable that this month’s column concentrates on the main issue on everyone’s mind – the current crisis in which we find ourselves, writes Will Mooney, Partner, Carter Jonas Cambridge. 

There is no getting away from it, try as we might to switch conversations to other topics, they inevitably lead back to the pandemic, and its impact on nearly every aspect of our lives – some trivial, sadly many tragic.

Given the focus of this column, it seems right to discuss the pandemic in the context of real estate. As a firm, like many other businesses in our network, we have been working hard to reassure our clients that despite lockdown, we are here. 

Although physical offices are temporarily closed, teams are working and can be contacted on normal numbers and emails. Once that was established, we have had to adapt to how we support our clients and how we advise them. As well as the most pressing issues facing both landlords and occupiers, we are also dealing with long-term considerations.

Undoubtedly, the Covid-19 crisis will have a significant impact on the corporate occupier sector, at least in the short-term. When we talk of occupiers, of course, what we are really talking about are businesses with employees. 

In this climate, many clients are taking a wait-and-see approach before committing to high-capital-expenditure projects, such as an office relocation, to see what impact the pandemic has on revenues and staff headcount. 

I have mentioned before that real estate often represents the second largest operating cost of most businesses, after staff salaries. It is very likely then that in the coming months, some businesses will be implementing policies to downsize and reduce their exposure to property costs.

Further, developers have had to shut down construction of new office buildings which will disrupt completion timelines and office moves. A number of occupiers that have entered pre-completion of construction letting agreements are now looking to extend their leases on their existing premises to tide them over until the building that they were scheduled to move to is ready. 

Whilst many landlords are working to accommodate such requests, difficulties arise when the tenant’s existing space has already been committed to another occupier. 

In these circumstances, occupiers that have been affected by the delayed completion are considering alternative temporary accommodation – serviced offices being an obvious solution.

Equally, some tenants with lease expiries, that have not already committed to a contract on alternative premises, are looking to defer a planned office move and seek a short-term lease extension from their landlord. Instead, they are planning a reassessment of the business’ operational and floorspace needs later, when economic conditions become more certain.

Whilst office demand remained relatively strong before the COVID-19 crisis, the supply of quality space has been highly constrained. Construction activity has been subdued ever since the financial crisis a decade ago and has been on a downward trend over the last two years. 

As a result, there is a shortage of grade A supply relative to robust demand in many markets, which will help to cushion rental falls at the prime end. 
However, even a small decrease in rents could lead to buildings that might have once been considered too expensive for some occupiers, now priced at a level that is attractive enough to encourage movement. 

Additionally, some landlords may well have the opportunity to restructure tenancies with their existing tenants and keep space filled and income-producing.

The longer-term impact of the enforced and potentially lengthy period of working at home for many office employees is difficult to gauge. The current situation will likely lead to a readjustment as to how many of us operate and utilise space. 

It is expected to accelerate the trend towards home working and lead to businesses reviewing their operating practices. I think it may also bring into sharper focus the importance of office space as a place to communicate, share ideas, foster team spirit and corporate identity.

It is an understatement to say that the current situation is challenging. As businesses grapple with planning for their future, against a backdrop of much uncertainty and in a climate that is constantly evolving, few issues will be easy to determine. However, solutions are being found. 

Whether you have a pressing concern or are trying to understand how your business may be affected, do keep asking questions and talking to people who can help. 

And, as I said last month, I hope that you are all safe and sound and keeping well.

In the current COVID-19 crisis, governments around the world are turning to businesses and research organisations in the life sciences sector to assist in meeting the challenge, writes James Fry, Partner and head of the life sciences practice at law firm Mills & Reeve. 

We are seeing new levels of innovation and collaboration around the development, at real pace, of vaccines, diagnostic kits and medical devices, as well as the repurposing of medicines for treatment of COVID-19 and the repurposing of businesses to address current needs based on existing biotech platforms. 

At the same time, the industry faces numerous difficulties. Supply chains are being disrupted, transport is curtailed and members of staff are unwell or in isolation. 

Here I review some of the issues being encountered, and steps that can be taken to reduce risk and exposure to loss. I also consider what steps governments and regulators are taking in response to the crisis.

Clinical trials

The conduct of existing clinical trials is severely affected by the pandemic. Clinical staff resource is naturally being redirected towards tackling the crisis. Travel of trial participants to and from clinical trials sites is curtailed in many countries. 

Even where travel is permitted, individuals may be reluctant to attend a clinical setting due to possible exposure to infected patients. Remote monitoring may be necessary, where this is a feasible option. Wet ink signatures are more difficult to obtain, and it may become necessary to post trial medicines directly to participants.

Delays to the completion of clinical trials are leading to knock-on delays in drug development programmes. A business’s pipeline may be put back by several months meaning that planned funding resources may be insufficient, and making it more difficult for businesses to engage in new fund-raising activity.

In the face of these difficulties, it will be welcome news that regulators are showing flexibility. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance indicating that a flexible and pragmatic approach is being taken, provided that the safety of participants remains paramount. 

It may be appropriate, for example, to consider a temporary halt to a trial. Where risk assessment indicates that it is preferable to continue the trial risk mitigation steps can be used to maintain appropriate levels of safety.

Likewise, the European Medicines Agency (EMA) has issued guidance on how to manage clinical trials during the crisis. Developed alongside member state representatives, the guidance encourages consideration of measures that could be appropriate. 

In extreme circumstances, a temporary halt of the trial at all sites may be necessary, but other methods such as phone or video visits, and local laboratory, imaging or diagnostic testing may provide appropriate alternatives. 

At all times, good communication with the relevant ethics committees and regulators should be maintained, and of course, participant safety remains paramount.

US FDA guidance addresses similar issues to assist clinical trial sponsors in navigating through the current difficulties.

Clearly, sponsors and others involved in the conduct of clinical trials need to assess existing contracts to understand how delays in programmes can be managed within existing contracts, or whether contracts need to be varied. 

Consideration also needs to be given as to whether existing contracts may be terminated (eg for force majeure or other reasons) and how this impacts clinical development programmes.

Regulatory submissions and compliance

Many businesses are finding that regulators are very stretched. This means that approvals of new products are facing delays. Although a focus on managing the crisis and fast-tracking the review of COVID-19 related drug and vaccine candidates is necessary, this leaves other drug candidates with longer development times than expected, impacting on pipelines and investment cycles. 

Many contracts (eg IP licences) may be dependent on regulatory approvals being applied for or obtained by particular dates with rights to terminate or re-negotiate flowing from delays in the regulatory approval process.

Normal compliance activity is also affected, and regulators are looking at ways to introduce temporary measures in response. The MHRA, for example, is implementing a set of temporary regulatory flexibilities to respond to the crisis. A new approach to remote working by Qualified Persons will allow batch certification by an offsite QP.

During the crisis, on-site MHRA GxP inspections will be limited to the Government’s COVID-19 response or a potential serious public health risk, and assuming that remote assessment is not possible. 

In other situations, approaches such as office-based assessment of information and documents, with follow up using teleconferences and email. Future on-site visits may be arranged for a time when travel restrictions are alleviated.

Medical devices

Those in the medical devices industry will have been gearing up for the introduction of the EU’s new regulatory regime. Due to have been fully rolled out on 26 May 2020 (for general medical devices), this deadline is being pushed back by 12 months to avoid imposing unnecessary burdens on industry and regulators during the crisis. 

The EU Commission’s stated intention is to avoid “any potential market disruptions regarding the availability of safe and essential medical devices”. Amending legislation has been rushed through and will see the existing law maintained for the coming year.

While the delay makes sense in terms of removing any unnecessary burdens on both users of the system and member state authorities during the current crisis, many device producers will already have taken steps to adhere to the new system and may therefore not realise much benefit.

Supply chains, and moving goods and materials cross border

The life sciences sector is highly international, with multinational operations and supply chains the norm. In situations where a key supplier is unable to maintain supplies, it may be possible to find an alternative source. However, the customer will need to be aware of possible difficulties in simply switching to an alternative supplier. For example, the product or components being sourced may require access to proprietary technology. 

Where IP rights owned by the usual supplier that will be needed for the secondary supply, it may be necessary to seek a licence or find an alternative approach. Using an alternative supplier could lead to IP infringement or other proceedings if the necessary permissions are not in place.

Moving medicines and highly specialised materials cross border now face new restrictions, and these are subject to regular additions and updates to reflect changing national priorities. 

In the UK, the list of restricted medicines for parallel export has been extended to include numerous commonly used medications, like treatments for asthma, antibiotics and pain management drugs.

In the EU, a new programme to address shortages of critical medicines (the i-SPOC, or industry single point of contact) will coordinate information on anticipated or current shortages of critical medicines in order to minimise the impact of shortages.

Emergency legislation issued by the EU Commission on 15 March placed controls on the export of personal protective equipment, such as visors, mouth-nose protection and protective clothing. 

Permission was required for exports of certain items out of the EU. The measures are temporary and subject to regular review. Following the initial six-week period, the measures were adjusted to reduce the list of protected products.

While in some areas tighter restrictions are being imposed, others are seeing a temporary relaxation. EU rules on customs duties and VAT are being loosened in the short term to support efforts to secure vital supplies. The UK and EU countries have temporary permission to waive duties and VAT on imported supplies of much-needed medical equipment.

Digital health

There is a particular focus on what digital health tools can offer during this period. Vast pools of data must be gathered in order to accurately track and predict the course of the pandemic. 

Current (albeit time limited) guidance on information governance indicates flexibility in approach to permit data sharing where necessary to tackle the public health crisis.

Two other areas are attracting attention. First, remote consultations are becoming increasingly important. For primary care clinicians, telehealth previously offered convenience and flexibility. 

Now it may be vital for patents unable to travel, and to prevent infection of healthcare staff. UK digital health organisation NHSX is accelerating rollout of remote consultation tools.

Second, new digital apps are being developed and rolled out to gather information about the spread of symptoms among populations, and importantly to notify contacts of a possible infected person at an early stage. NHSX has begun trialing its contact tracing app on the Isle of Wight.

As always with digital health tools, compliance with patient confidentiality, and data privacy and security law, is key. NHSX emphasises the anonymous nature of the information collected by the contact tracing app, although some still have serious concerns about a project that looks like state surveillance of individuals.

Looking beyond the crisis

In the current phase of increasing or peaking infection rates, organisations are focusing on how to manage the current crisis. However, it remains important to plan for the future. 

Once supply chain disruption begins to lift, for example, there is likely to be competition for access to biological materials, IP and other scarce resources. 

Suppliers/providers may find themselves having to prioritise competing demands from customers and others. Both China and India are important global players in the supply of base materials, and manufacture in both countries is being severely affected by the crisis.

Alterations to clinical trial methodology should include plans to resume normal activity once conditions permit. Likewise, approval processes will need to be progressed as quickly as possible when the pressure on regulators begins to ease.

We are seeing the most forward thinking businesses look to the post-crisis phase, and prepare to restart or accelerate activities as restrictions begin to lift.

mills-reeve.com

Cambridge-based cyber security world leader Darktrace continues to work towards an IPO – possibly in the US and UK – next year after growing its market capitalisation to more than $2 billion.

Sources close to the company say Darktrace would have hit the markets by now had it not been for the coronavirus pandemic.

Ironically, while frustrating the projected float, the crisis has seen major international companies turning to Darktrace to protect their systems from potentially fatal attacks.

Management are known to be keen to execute the IPO, which will provide windfall payouts for a number of executives, sooner rather than later and are just waiting for a window of opportunity.

Darktrace has grown impressively and consistently under the dual transatlantic CEO model of Poppy Gustafsson in Cambridge and Nicole Eagan in the US.

The company has piled up the revenues while cutting outlay in a supreme last 12 months and has so far raised not far shy of $250 million; it now employs around 1,000 people globally.

The number of customers using Darktrace’s AI email solution, Antigena Email, has doubled since January 2020, while the number of requests to trial Antigena Email has quadrupled since the lockdown began in early March.

Darktrace can also reveal that in the month of April 60 per cent of all advanced spear-phishing attacks blocked by Antigena Email either related to COVID-19 or aimed to trick employees by referencing remote working. 

Attackers are exploiting concerns about the virus to convince people to open emails and click on malicious links in a trend called ‘fearware’ – using over 130,000 newly-created email domains related to coronavirus to bypass standard spam filters.

Antigena Email’s ability to distinguish malicious emails from legitimate business communications – and stop those emails from ever reaching the employee’s inbox – has never been more critical. 

Powered by cyber AI, the technology works by forming an evolving understanding of ‘normal activity’ for corporate email environments and the individual users within them. This enables it to detect incoming novel and targeted attacks that traditional tools let through, including domain spoofing, supply chain account takeovers, and impersonation attempts.

Darktrace has stopped numerous instances of ‘fearware’ across its customer base, including attackers posing as the Center for Disease Control (CDC) and World Health Organization and, more recently, attackers spoofing company email addresses to deliver false corporate updates. 

At the leading LA production studio Bunim/Murray, Antigena Email caught several phishing emails purporting to deliver corporate COVID-19 updates to employees. The emails were automatically stopped by Darktrace AI before they could make it into employees’ inboxes.

Mike Lynch, the Cambridge technology entrepreneur, has backed Darktrace since inception and the Invoke Capital fund he founded also has high hopes for stablemate Luminance which is massively commercialising its AI platform for the legal profession.

The feeling within Invoke is that lawyers will have to work overtime when the initial phase of the COVID-19 crisis is over and a lot of interest has already been expressed by global law firms as to how Luminance’s AI expertise can help with a projected surge in workload.

The Mike Lynch camp awaits a verdict from the UK High Court battle between the entrepreneur and US giant HP over alleged fraud in the sale of Autonomy. A verdict could be delivered as early as this summer although the judge is free until October to complete his deliberations. 

Until that verdict is delivered nothing is expected to happen on Lynch’s proposed extradition to the US to face fraud charges there over the same Autonomy deal – allegations he fervently denies.

In any event a possible US extradition hearing has already been shifted to January 2021 – which might be viewed as an indication that extradition is not exactly highest on the list of any party’s priorities at this juncture.

AstraZeneca has announced a trio of developments regarding treatments for gastric and ovarian cancer as well as Crohn’s disease and ulcerative colitis.

The company reveals that, in conjunction with Merck, its potential blockbuster drug Lynparza has been approved in the US as a 1st-line maintenance treatment and alongside bevacizumab will be used to treat large numbers of patients with advanced ovarian cancer.

One in two women with advanced ovarian cancer has an HRD-positive tumour (homologous recombination deficiency). 

For patients with advanced ovarian cancer, the primary aim of 1st-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission. 

Patients will be chosen for therapy based on an FDA-approved companion diagnostic test.

The approval by the US FDA was based on a biomarker subgroup analysis of the Phase III PAOLA-1 trial which showed that Lynparza in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67 per cent.

Dave Fredrickson, executive VP, Oncology Business Unit, said: “This approval represents another milestone for Lynparza in patients with ovarian cancer. The median progression-free survival of more than three years offers new hope for more women to delay relapse in this difficult-to-treat disease.

“These results further establish that HRD-positive is a distinct subset of ovarian cancer, and HRD testing is now a critical component for the diagnosis and tailoring of treatment for women with advanced ovarian cancer.”

AstraZeneca, based at the science & technology hotspot at Cambridge Biomedical Campus, also announces a second US breakthrough therapy designation for Enhertu, a new medicine.

Along with Daiichi Sankyo Company, AstraZeneca says the approval is for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.

Gastric cancer is the third leading cause of cancer mortality with a five-year survival rate of five per cent for metastatic disease.

José Baselga, executive VP, R & D Oncology, said: “Current therapy options are limited for patients with HER2-positive metastatic gastric cancer and for those who relapse, there are no approved HER2-targeted medicines. 

“We look forward to working with the FDA to further explore the potential of Enhertu to become an important new treatment and the first antibody drug conjugate for this devastating disease.”

AstraZeneca has also completed a previously communicated agreement to recover the global rights to brazikumab (formerly MEDI2070), a monoclonal antibody targeting IL23, from Allergan. 

AstraZeneca and Allergan have terminated their previous licence agreement and all rights to brazikumab have now returned to AstraZeneca.

Under the termination agreement, Allergan will fund up to an agreed amount, estimated to be the total costs expected to be incurred by AstraZeneca until completion of the development of brazikumab for Crohn’s disease (CD) and ulcerative colitis (UC), including the development of a companion diagnostic.

Pursuant to the 2012 collaboration between Amgen and AstraZeneca to jointly develop and commercialise a clinical-stage inflammation portfolio, including brazikumab, Amgen is entitled to receive a high single-digit to low double-digit royalty on sales of brazikumab if approved and launched. 

This includes the original inventor royalty. Other than this, AstraZeneca will own all rights and benefits arising from the medicine with no other payments due to Amgen or Allergan.

Until recently, we would normally begin the opening sentence of a sector update with the words ‘In the last quarter’ reflecting what would be about to follow, writes Tony Jones, chief executive of life sciences membership organisation, One Nucleus.

Whether in terms of deals announced, product launches or investment raised, the region’s life science sector has continually delivered great news for some time. Recently nothing has felt normal however – or has it? 

COVID-19 has changed what any one of us would consider normality. Social distancing, international travel bans and Open Innovation on a scale we could never have imagined as we have collectively sought to battle a common enemy. 

The decades of investment, both public and private, into the region’s life science cluster have rendered it as well placed as any location to respond. Layer on that the excellence of our research base, world-leading innovation across multiple industries and the fact that invention and innovation run in the blood here, means you have a platform to respond quickly and at scale. 

Some of that response has played directly into the national, and indeed international response to COVID-19, whereas some has fittingly supported the local need.

The UK life sciences sector started 2020 in great shape. It attracted over £300 million between December 2019 and February 2020. Not quite at the levels of the preceding year but still hugely impressive with both venture capital and public markets providing significant finance to enable our companies to progress their products through development. 

A notable example in the region was the Freeline Therapeutics’ £61m investment from Syncona in December. Freeline has subsequently bolstered its senior team and just this week have announced that the FDA has granted Orphan Drug Designation for its novel Fabry Disease model. 

We have also seen another regional star, Healx, announce its collaboration with Boehringer Ingleheim, applying its AI technology to the field of neurological disorders. These are examples of our strengths, but when COVID-19 struck we saw the true strength of the region’s sector come to the fore.

There can be no doubt of the importance of testing, vaccines and treatments to the way out of this period. As rapidly as March 23, the day the UK Government announced our version of lockdown, the Quadram Institute announced how it was part of the £20m national programme to use whole genome sequencing to start to understand the spread of COVID-19. 

By April 7 we saw three of the region’s major players, AstraZeneca, GSK and the University of Cambridge come together to support the creation of a new testing lab. 

We also saw great work from Cambridge Clinical Laboratories in coordinating the ‘smaller testing ships’ in the region in offering up support. This led to them joining with the national COVID-19 Volunteer Testing Network to provide support to the work of the PHE and NHS testing laboratories. 

Pulling together these numerous smaller providers, some not diagnostics labs but with molecular expertise to offer, addressed a key capacity challenge the central UK coordinators clearly found significant: It is a wonderful example of how our region is enabled by champions willing to play their part. 

One of the strengths of the cluster here is the proximity of the different industrial sectors when it comes to needing inter-disciplinary solutions. 

There have been some excellent examples of collaborations across the divides. Avacta collaborating with Cytiva springs to mind as life science meets engineering with the aim of developing, validating and manufacture their point-of-care test in double quick time. 

Even within their own field, we saw manufacturers respond to divert normal manufacturing lines into producing much required Personal Protective Equipment (PPE). 

Just north of our patch we saw a great example at BoxMart. Their normal business is to produce bespoke cardboard packaging for everything from personalised gifts to hampers. Answering the call for PPE, BoxMart transitioned to focus on making single-use, reinforced PPE face shields, even finding scope to develop rainbow patterned child friendly versions. 

It was an innovative and rapid change of direction when they knew our real heroes needed them. Availability of PPE became a serious matter as we are all aware. Again, the challenge was met with solutions in the region. 

The University of Cambridge, with support from the likes of The Milner Institute, coordinated an extremely effective campaign seeking donations of PPE for NHS staff. 

Utilising the product tracking technology of their spinout company RedBite, they established a local supply chain and distribution platform for donated PPE: Life-saving activity supported not only by those companies active in COVID-19 research but also by numerous neighbour companies ready to donate what PPE they had in their labs. Millions of items have been donated and put to the greater good.

And what of vaccines and treatments? It will be a huge and international R & D effort to discover, test, manufacture and distribute effective vaccines – that is for certain. Competition falls by the wayside when such a pandemic is upon us and collaboration at a global scale is what is required. We see AstraZeneca collaborating with Oxford University teams on developing a novel vaccine at scale for example and through the US Government DARPA programme collaborating with institutions from US and China to discover neutralising antibodies. 

The innovation, collaborations and talent available in the cluster was a major draw for AstraZeneca’s relocation here and I am sure that engagement pipeline will play its full role in influencing how we emerge from COVID-19. 

Important around this focus on the pandemic, however, is to remember that we will emerge from this period. Maybe our daily activities and thought processes changed to a greater or lesser degree but emerge we shall. 

It is important to note therefore whilst we describe COVID-19 responses above, many of the life science businesses based here have adapted in the midst of all this to continue creating value, doing deals and ensuring the region emerges as strongly as possible. 

We have seen fantastic news from the likes of Inivata who have launched the RaDaR Assay liquid biopsy product. Nanna Therapeutics has been acquired by Astellas Pharma, providing the resource to forge ahead with their age-related disease focused pipeline and Mogrify announcing its collaboration with Sangamo Therapeutics to leverage Mogrify’s iPSC- and ESC- derived T-cells. 

Such news flow and progress leave the region in a position of strength when the new normality settles, perhaps taking a good slice from one of the seven >£1Billion dollar fund closings announced in the US during this period. 

So yes, perhaps nothing day-to-day has felt normal, but look a bit more closely at the life sciences sector and perhaps we have to date under-estimated what day-to-day normal represents. 

Meeting the challenges of COVID-19 has required a commitment to collaboration, a dynamically innovative mindset, a sense of community and a resilience to adapt quickly in order to succeed. 

The nature of the life sciences sector and the entrepreneurs within it is one of being able to roll with the punches, take stock and then execute an amended plan. 

Whether attacking COVID-19, driving forward in a different therapy area (those diseases have not gone away) or simply using expertise to reassure colleagues and contacts with adept interpretation of data, the region has delivered by the lorry load. 

Of course, it is also clear that such regional contribution is only possible due to the investment over previous decades in attracting the brightest minds to such an effective ecosystem. 

This last point I would hope to see policy makers remember when COVID-19 is something we refer back to and so the agenda of ensuring the UK remains a world force in life sciences does not overlook the need to continue investing that is based primarily on excellence not geography.

onenucleus.com