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

Cambridge UK life science technology business Avacta has joined forces with Adeptrix Corporation in Massachusetts to develop and manufacture a high throughput COVID-19 antigen test using Adeptrix’s proprietary bead-assisted mass spectrometry (BAMS™) platform.

Quoted Avacta Group is the developer of the much vaunted Affimer® biotherapeutics and reagents.

The coronavirus antigen test will provide clinicians with a significant expansion of the available testing capacity for COVID-19 infection in hospitals.

Adeptrix’s novel BAMS platform combines enrichment of the sample to improve sensitivity with the power of mass-spectrometry to improve specificity. 

Hundreds of samples per day can be analysed by a single technician using BAMS, exceeding the capacity of single PCR machine. It makes BAMS a very attractive high throughput technique for COVID-19 screening in the clinical setting.

The diagnostic test will allow hospitals around the world to utilise their existing installed base of mass spectrometers that are not currently used for COVID-19 testing, contributing significantly to the increase in global testing capacity. 

Avacta’s recently developed Affimer reagents that bind the SARS-COV-2 spike protein will be used to provide the capture and enrichment of the virus particle from the sample which could be saliva, nasopharyngeal swabs or serum.  

Development of a BAMS test capable of diagnosing whether a person has the COVID-19 infection at any specific moment is a quick process and the companies are aiming to have a BAMS test ready for clinical validation, regulatory approval and manufacturing in June. 

Adeptrix and Avacta are already in discussion with large-scale manufacturing partners to rapidly deploy this new high throughput test. Further commercial details are not being disclosed but Avacta will receive a royalty on the sales of BAMS test kits by Adeptrix.

Dr Alastair Smith, Avacta Group’s CEO, said: “We are delighted to have established this partnership with Adeptrix in our push to develop Affimer -based COVID-19 antigen tests. 

“Jeff Silva and his team are world-renowned in the mass spectrometry field and the BAMS diagnostic platform is highly sensitive and specific, giving us great confidence that a high performance COVID-19 antigen test can be developed and launched commercially very quickly.

“We believe that the BAMS test will be hugely attractive as an adjunct to PCR testing because it uses laboratory equipment that is already in hospital labs but not currently used for COVID-19 testing so it provides incremental testing capacity.

“A consensus view is building around the world that hundreds of millions of COVID-19 tests are going to be required per month for a long period and that the disease will be endemic after the initial pandemic has passed, meaning that testing for COVID-19 is going to be needed for many years.

“I have made it clear that we intend to partner the SARS-COV-2 spike protein Affimer reagents with several select companies to support antigen test development on multiple diagnostic test platforms.

“This will contribute most effectively to the urgent need to increase antigen testing capacity globally and maximise the commercial return to Avacta. Adeptrix is one example of this and other discussions are underway.”

Dr. Jeffrey C. Silva, director of product development at Adeptrix Corporation added: “I am pleased to have Avacta recognise the promise of the BAMS technology with respect to its sensitivity, accuracy and high throughput capacity.

“I have worked with Affimers previously and found them to be excellent immunoassay reagents, so we are looking forward to quickly implementing the SARS-COV-2 Affimers in a BAMS diagnostic test.

“Mass spectrometry can enhance the diagnostic utility of immunoassays, as it is capable of monitoring both existing and emerging viral strains by accurately measuring the molecular components of the virus.

“BAMS provides an ideal multiplexing platform to obtain higher specificity for monitoring COVID-19 infection.”

Cambridge Big Biotech business AstraZeneca is teaming up with Oxford University to fast-track manufacture and distribution worldwide of a ‘Holy Grail’ COVID-19 vaccine.

The collaboration aims to bring to patients the potential vaccine known as ChAdOx1 nCoV-19, being developed by the Jenner Institute and Oxford Vaccine Group at the university. 

AstraZeneca will be responsible for development and worldwide manufacturing as well as distribution of the vaccine.

Pascal Soriot, CEO at AstraZeneca, said: “As COVID-19 continues its grip on the world, the need for a vaccine to defeat the virus is urgent.

“This collaboration brings together the University of Oxford’s world-class expertise in vaccinology and AstraZeneca’s global development, manufacturing and distribution capabilities. 

“Our hope is that, by joining forces, we can accelerate the globalisation of a vaccine to combat the virus and protect people from the deadliest pandemic in a generation.”

His colleague Mene Pangalos, executive VP, BioPharmaceuticals R & D, added: “The University of Oxford and AstraZeneca have a longstanding relationship to advance basic research and we are hugely excited to be working with them on advancing a vaccine to prevent COVID-19 around the world. We are looking forward to working with the University of Oxford and innovative companies such as Vaccitech, as part of our new partnership.”  

UK Business Secretary Alok Sharma, described the collaboration as absolutely critical to the campaign to eradicate the virus.He said: “This collaboration between Oxford University and AstraZeneca is a vital step that could help rapidly advance the manufacture of a coronavirus vaccine.

“It will also ensure that, should the vaccine being developed by Oxford University’s Jenner Institute work, it will be available as early as possible, helping to protect thousands of lives from this disease.”

The potential vaccine entered Phase I clinical trials last week to study safety and efficacy in healthy volunteers aged 18 to 55 years, across five trial centres in Southern England. 

Data from the Phase I trial could be available as early as next month and advancement to late-stage trials should take place by the middle of this year.

The recombinant adenovirus vector (ChAdOx1) was chosen to generate a strong immune response from a single dose and it is not replicating, so cannot cause an ongoing infection in a vaccinated individual. 

Vaccines made from the ChAdOx1 virus have been given to more than 320 people to date and have been shown to be safe and well tolerated, although they can cause temporary side effects such as a temperature, flu-like symptoms, headache or sore arm.

AstraZeneca, now globally headquartered in the Cambridge UK technology cluster, has been in the front line of the fight against COVID-19 from the outset, using its planet-wide power and influence to forge partnerships with contemporaries, governments and academic institutions to advance potential solutions to the killer virus.

Cambridge University spin-out, Xampla, dedicated to reduce microplastic pollution, has raised £2 million seed funding. 

The round was co-led by the university’s commercialisation arm Cambridge Enterprise and global technology investor Amadeus Capital Partners – co-founded by Hermann Hauser – with participation from Sky media group’s impact investment fund Sky Ocean Ventures and the University of Cambridge Enterprise Fund VI, managed by Parkwalk.

Xampla is developing the world’s first plant protein-based replacement for microplastics added to everyday items. The funding will enable the startup to develop its prototype material into products. 

Its initial target is the $12 billion microencapsulation market in which manufacturers of home and personal care products currently rely on synthetic polymer capsules, a usage the EU is considering banning.

Dr Elaine Loukes, Investment Director, Cambridge Enterprise, said: “Xampla has come up with a remarkable alternative to plastic. The fabrication process mimics those used by nature and the product is entirely made from natural materials. We are very pleased to be supporting a company with the potential for tremendous beneficial impact.”

Unlike current alternatives to microplastics, which are based on plant polysaccharides, such as cellulose and algae, Xampla’s plant protein materials do not rely on chemical cross-linking for their performance. This enables them to decompose quickly and completely in the natural environment.

Amelia Armour, Principal, Amadeus Capital Partners, said: “Xampla is a great example of deep tech emerging from the UK research base at exactly the right time to respond to regulatory changes and consumer trends around plastic. 

“We’re excited to be investing alongside an impact investor and backing a world-class science team that can offer commercial solutions for multiple industries.”

In proposing regulations on added microplastics, the European Chemicals Agency (ECHA) found that each year in Europe added microplastics equivalent to 10 billion plastic bottles were released into the environment and were practically impossible to remove.

Simon Hombersley, Xampla CEO, explained: “Our mission is to reduce the impact of single-use plastic, and our initial commercial focus is on intentionally-added microplastics.

“With our new plant protein material, we are committed to helping manufacturers make the transition from traditional plastics to high performance alternatives that protect the planet.”

The creation of the new material stems from a breakthrough from protein experts Professor Tuomas Knowles – a prolific founder of great tech companies from the UK – and Dr Marc Rodriguez-Garcia, inspired by the process a spider uses to create silk. 

Xampla facilitates a similar transformation at scale and in a very efficient process by using widely-available and renewable plant proteins, without the need for harmful solvents. 

The resulting Supramolecular Engineered Protein can be structured into plastic-like materials such as films, gels and capsules. Xampla holds two patents for the new material, with a third in development.

The scale of the potential economic impact of the EU’s proposed restriction can be seen in data submitted by the industry to the ECHA’s stakeholder workshop. 

For example, Cosmetics Europe, the trade body representing the European cosmetics and personal care industry, stated that a restriction of microplastics in both rinse-off and leave-on products would affect 24,172 formulations, resulting in loss of revenue for the industry of 12.2 billion euros per year.

Professor Knowles has already spun Fluidic Analytics and Wren Therapeutics out of his laboratory at the University of Cambridge.

Fluidic Analytics raised $31 million in 2018 to continue developing its transformational products for characterising proteins and their behaviour. The financing was led by Draper Esprit, a pan-European venture capital fund that invests in disruptive technology companies at the early and growth stages. Joining the round as new investors were Delin Ventures and BGF, making its largest life-sciences investment to date and first in Cambridge. IQ Capital and Amadeus Capital Partners also joined Draper Esprit in backing Fluidic for a third successive time since the company’s first financing in 2015.

Wren Therapeutics was founded in 2016 – a spin-off company from the University of Cambridge and Lund University in Sweden. It is focused on drug discovery and development for protein misfolding diseases.The company was founded by Proessor Knowles, Sir Chris Dobson, Michele Vendruscolo, Sam Cohen, Sara Linse and Johnny Habchi. It raised £18m in January 2019 from an international syndicate led by The Baupost Group with participation from LifeForce Capital and a number of private investors. 

One Cambridge technology consultancy has failed to make the cut and three others are sweating on Government decisions in the coming week on which projects will continue to be supported under the Ventilator Challenge launched to counter COVID-19.

Cabinet chiefs Michael Gove and Matt Hancock, the Health Secretary, have unveiled which ventilator design projects are being backed, which still have a chance of continued support and which have been ruled out.

The Cabinet Office has ceased support for EVA, made by Team Consulting and Cogent Technology, along with three other designs from elsewhere in the UK.

Veloci-Vent, made by Cambridge Consultants Ltd and MetLase, the Sagentia Ventilator made by Sagentia and CoVent, made by TTP and Dyson, are among five projects which will continue to be eligible for support but only until being reassessed by a further clinical panel in the week ahead.

As things stand 11 devices are receiving support as part of the drive to increase ventilator supply and protect the NHS.

Following the recommendations of the expert panel, the Government will continue to provide support to four devices, as well the Penlon and paraPAC. It is scaling up production of existing Breas Medical devices, the Nippy 4+ & Vivo65, with the first units expected next month. In addition, two devices are subject to ongoing review to ensure that they continue to meet the needs of the NHS – Zephyr Plus, made by Babcock and Gemini, made by OES Medical.

The Government says its efforts to increase ventilator capacity have already seen an additional 2,400 mechanical ventilators made available to the NHS since the start of the pandemic with over 250 coming from the Ventilator Challenge so far. The number of extra ventilators rises to 6,745 in total when you include both mechanical and non-invasive ventilators; it adds that the UK now has 10,900 mechanical invasive ventilators available to the NHS, as well as 4,300 non-invasive devices.

Chancellor of the Duchy of Lancaster Michael Gove said: “The innovation, teamwork and commitment shown by manufacturers involved in the Ventilator Challenge has been inspirational. Everyone involved are heroes of our national effort and their contribution to protecting our NHS and saving lives will not be forgotten.”

Health Secretary Matt Hancock added: “Since we launched the Ventilator Challenge the ingenuity and innovation shown by so many companies has been truly awe-inspiring and has helped us continue to get ventilators to the frontline and keep capacity ahead of demand.

“Technology and innovation, operating hand-in-hand with the care and dedication of our fantastic health and social care staff, will help us overcome this virus.”

Cambridge technology giant and social enterprise evangelist Arm has triggered a new era in silicon prototype development by offering startups in the sector free access to its chip designs – the most widely used on the planet.

The superchip designer says the new program combined with the Arm ecosystem lowers design risk and could fast-track time to market for developed prototypes by anything from six to 12 months. 

This is a huge commercial uptick for silicon startups often handicapped by going it alone. Silicon is used extensively as a semiconductor in solid-state devices in the computer and microelectronics industries and startups can now scale with more speed and confidence thanks to Arm’s philanthropic generosity.

The new programme is being delivered through a novel extension of the Arm Flexible Access venture launched last year. This week sees the official launch of Arm Flexible Access for Startups and offers no-cost access to world’s most trusted IP portfolio, tools, training and full support for early-experimentation, design and prototype silicon.

Instrumental to the launch, Arm is partnering with Silicon Catalyst, a specialist incubator for silicon startups.

Dipti Vachani, senior vice-president and general manager, Automotive and IoT Line of Business at Arm, said: “In today’s challenging business landscape, enabling innovation is critical. Now more than ever, startups with brilliant ideas need the fastest, most trusted route to success and scale.

“Arm Flexible Access for Startups offers new silicon entrants a faster, more cost-efficient path to working prototypes, resulting in strengthened investor confidence for future funding.”

Early-stage startups in the sector can now access a wide range of Arm IP allowing them to experiment, design and prototype with various Arm solutions throughout the product development cycle. 

Arm defines “early-stage” as startups with up to $5m in funding. Startups meeting these criteria will have access to a broad portfolio of Arm-based processors, including IP from the Arm Cortex®-A, -R and -M processor families, select Arm MaliTM GPUs, ISPs, and other foundational SoC building blocks. 

Startups will also be able to supplement their in-house skills and experience with access to Arm’s leading ecosystem of silicon designers, software developers, support, training and tools.

Emerging use cases in areas such as AI at the edge, autonomous vehicles and IoT have spurred a new wave of silicon startups, as illustrated by new insights from Semico Research. Report findings show:-

• There has been a 10 X increase in funding from 2016 to 2019. In the last five years silicon startups have received more than $1.3 billion in funding
• Over a third of startups that have emerged in the past five years are targeting automotive, with another third targeting IoT applications
• In terms of key challenges, semiconductor startups have small engineering teams facing the increasing complexity of SoC designs and need to satisfy a growing range of customer and market requirements in the shortest timeframes possible
• Missing a market window could mean the difference between success or failure, so they rely heavily on a strong ecosystem to enable fast, low risk and robust product development in order to quickly, cost effectively bring a product to proof of concept and beyond.

The strategic partnership with Silicon Catalyst is another significant development in the industry. The incubator is focused exclusively on helping startups accelerate silicon solutions. 

Silicon Catalyst members can now access Arm IP, EDA tools and prototype silicon for free – significantly reducing costs at the critical stage of the business.

This latest announcement builds on the early success of the Arm Flexible Access program launched last year, which enables partners to pay an annual fee for immediate access to a broad portfolio of technology. 

The program has seen significant momentum, with more than 40 customers now registered, covering areas such as IoT, AI at the edge, autonomous vehicles and medical wearables. 

Arm already has a successful track record in driving engagements with innovative smaller customers, hundreds of which have seen significant success using Arm technology, such as AI chip vendor, Hailo, and fabless semiconductor company, Atmosic. This new program will enable further engagements with emerging silicon startups.

Arm technology is at the heart of a computing and data revolution that is transforming the way people live and businesses operate. Its advanced, energy-efficient processor designs have enabled intelligent computing in more than 160 billion chips and its technologies now securely powers products from the sensor to the smartphone and the supercomputer. 

In combination with Arm’s IoT device, connectivity and data management platform, the company is also enabling customers with powerful and actionable business insights that are generating new value from their connected devices and data. 

Together with 1,000+ technology partners Arm is at the forefront of designing, securing and managing all areas of compute from the chip to the cloud.

Cambridge Big Biotech AstraZeneca delivered a stunning performance in the first quarter of 2020 – combining dual roles as white knight to the healthcare community in the eye of the COVID-19 storm and darling of the stockmarket with rocketing revenues across all therapy areas and geographies.

The UK business hoisted revenues 16 per cent to $6.354 billion; this included product sales 15 per cent higher at $6.311bn. 

The performance of new medicines improved 47 per cent to $2.986bn, including new-medicine growth in emerging markets of 82 per cent to $658 million.

Revenue growth was achieved across all therapy areas: Oncology +33 per cent to $2.518bn, New CVRM8 +7 per cent to $1.102bn and Respiratory & Immunology +21 per cent to $1.555bn.

Revenue growth was achieved in every region; China returns rose 14 per cent to $1.416bn; those in the US by 16 per cent to $2.091bn; in Europe by 22 per cent to $1.204bn; and in Japan by 10 per cent to $553m.

The stock rose 81.43p to 8,269.43 on the news on  Wednesday, taking market cap to a staggering £108.48 billion.

CEO Pascal Soriot said every single employee across the globe could take a bow for achieving such strong revenue and profit growth against such a difficult and tragic backdrop in the COVID-19 crisis.

Altruistic AstraZeneca was among the first responders to the pandemic – initially in China and then elsewhere around the world – while keeping its eye on the ball in terms of its own financial performance.

That the company delivered such a strong quarter reflected the immense efforts of supply-chain, commercial and other colleagues around the world to get vital medicines to patients, Soriot said. 

He added: “Our focus ensured another quarter of strong growth across every therapy area and region. The new medicines performed extremely well, and our pipeline continued to deliver. 

“Standouts included landmark news for Tagrisso, Farxiga and Koselugo, our latest oncology medicine. The progress made on all fronts provides confidence that we will, once again, meet our full-year commitments.

“I could not be prouder of how the AstraZeneca team has responded to the challenges of COVID-19. We moved quickly to maintain continuity of care, contribute to society, and use our scientific expertise to fight the pandemic.
 
“We hope our efforts to protect organs from damage, mitigate the cytokine storm and the associated hyperinflammatory state, and target the virus prove to be successful.”