BioScience Today Issue 23

SCIENCETODAY

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covid-19 • diagnostics • vaccines

ISSUE23

www.biosciencetoday.co.uk

| BIOSCIENCE TODAY |

| welcome |

foreword Helen Compson Editor in chief

Editor Helen Compson helen.compson@distinctivegroup.co.uk

PIONEERING UK RESEARCH CREATES NEW FRONTIERS IN THE TREATMENT OF DISEASE

Design

In a series of firsts we look at this issue, The Christie NHS Foundation Trust unveils a world first as it treats cervical cancer patient Karen Hall, 57, using an MR-guided linear accelerator.

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The first machine of its type, it carries out realtime MRI scans while it is actually targeting X-ray beams at tumours. The result is greater accuracy and reduced side effects.

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When it opened the UK’s first NHS high-energy proton beam centre in 2018, The Christie, in Manchester, became one of the only two places in the world to offer two particular types of pioneering radiotherapy treatment.

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Meanwhile, a new method for subtyping ovarian cancer has been validated in a collaboration between the University of Oxford and Imperial College London.

Researchers have discovered and identified sub-types of ovarian cancer cells that can then be used to accurately identify which are likely to lead to more severe outcomes. The approach has been christened the Oxford Classification of Carcinoma of the Ovary, or Oxford Classic for short.

Distinctive Publishing or BioScience Today cannot be held responsible for any inaccuracies that may occur, individual products or services advertised or late entries. No part of this publication may be reproduced or scanned without prior written permission of the publishers and BioScience Today.

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In another breakthrough, scientists at the Universities of Oxford and Edinburgh have produced a unique level of insight into the origins and behaviour of Covid-19 transmission chains following a comprehensive analysis of the first wave in the UK. It is the closest, most accurate genomic analysis of transmission in any epidemic to date.

And, over at the University of Bristol, a pioneering manufacturing process that both speeds up and reduces the costs of producing rapid medical diagnostic tools promises to democratise access to the effective treatment of disease.

The new technology has the potential to accelerate uptake and development of lab-ona-chip diagnostic techniques in parts of the world where rapid diagnoses are desperately needed to improve public health, mortality and morbidity.

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features

UK Government invests £5m to develop ‘library’ of mRNA vaccines

24 12 Research shows coronavirus can survive on healthcare uniforms for three days COVID-19 testing sector demand set to continue amid vaccine rollout

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contents / www.biosciencetoday.co.uk / issue 23 /

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Foreword

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Contents

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Industry Contributors

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intellectual property Freedom to Operate – Understanding the Risks.

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covid-19 Viruses similar to the strain that causes Covid-19 can survive on clothing and transmit to other surfaces for up to 72 hours, scientists at De Montfort University Leicester (DMU) have warned.

A team of scientists, led by researchers from the Universities of Oxford and Edinburgh, has analysed the first wave of the Covid-19 outbreak in the UK and produced the most fine-scaled and comprehensive genomic analysis of transmission of any epidemic to date.

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diagnostics Amid the continued high demand for testing and staggered vaccine rollout, the diagnostics industry, which was valued in 2020 at $17.2bn-$19.8bn, is set to rise further in 2021.

Pioneering technique paves way for fast and cheap fabrication of rapid medical diagnostic tools.

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innovation What makes a spinout?

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vaccines UK Government invests £5m to develop ‘library’ of mRNA vaccines.

36 Weaponising the fight against antibiotic resistance

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| industry contributors |

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Martin-Immanuel Bittner MD DPhil Co-Founder & CEO of Arctoris.

Alex is a UK and European qualified patent attorney with extensive experience in identifying and protecting innovations, and has spent many years working in-house in the medical device and diagnostic field.

Through his work with big corporates and multinationals Alex is able to bring a wealth of knowledge to his work with SMEs and start-ups to provide leading strategic IP advice.

Martin is the CEO of Arctoris that he co-founded in Oxford in 2016. He received his MD from the University of Freiburg in Germany, followed by his DPhil in Oncology as a Rhodes scholar at the University of Oxford. In recognition of his research achievements, Martin was elected a member of the Young Academy of the German National Academy of Sciences in 2018.

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Alex Bone Patent Attorney, Partner, AA Thornton

to advertise or contribute to the next edition advertising: tony.stephenson@ distinctivegroup.co.uk editorial: helen.compson@ distinctivegroup.co.uk

Dr Anne Lane CEO, UCL Business

Sonia Houghton CEO Cryoniss

Anne has a PhD in medicine from UCL and an Executive MBA from Molson Business School, Montreal. After research at UCL and Harvard Medical School, Anne worked for RTP Pharma Inc in Montreal, out-licensing and preparing valuations of the company’s portfolio for public listing. Anne joined UCL Ventures in 2000 and acted as consultant for the National Transfer Centre in the US. She is now CEO of UCLB, acts as Director and interim CEO on several of UCLB’s spinout companies and oversees the company’s licensing activity. Anne is also a member of the Licensing Executives Society (LES) and is on the committee for the Intellectual Property Lawyers Organisation (TIPLO).

Sonia is the CEO of Cryoniss, a contract service organisation providing next day delivery of qualified cell lines to global research institutions, pharmaceutical and biotech companies. Cryoniss is able to offer holistic support to customers including the acquisition of quality, ethically and legally sourced reagents, regulatory support, endto-end premium logistics management solutions and coordination of quality control testing of mammalian cell line reagents.

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Molecular ‘cookie cutter’ technique could provide key for COVID drug discovery University of Birmingham researchers are working to isolate and extract the COVID-19 encounter complex in a form that is stable enough for identification of target sites for future anti-viral drugs.

This initial project, which was funded by UKRI/BBSRC COVID-19 Rapid Response funding, also includes characterising the complex with a view to publishing its structure. The researchers have also received funding from Innovate UK that will enable a wider team to determine which area of the complex will be the most effective for antiviral drug discovery efforts.

The encounter complex is formed when the COVID-19 spike latches onto a binding site on an ACE-2 receptor, which is a complex protein embedded in cell membranes in the lungs, and cells that line the nose and airways.

The SMAs used in the study were provided by Netherlands-based company Orbiscope, which is a business unit of Polyscope Polymers B.V., and the world’s largest producer or SMAs for high-end applications including laminates for printed circuit boards, architectural and printed coatings, paints, performance materials used in cars, and cosmetics.

Although it was first isolated last year, the methods used involved full extraction of ACE-2 receptors from cell membranes, and this removal of the membrane’s supportive structure affects the stability of the receptor, which makes it difficult to study its structure and function.

The Birmingham researchers are using polymer-based molecular ‘cookie cutters’ to isolate the complex and keep it embedded in the cell membrane, so preserving the full structure of the molecule in its original context and in a stable form. The polymers are called Styrene Maleic Anhydrides, or SMAs, and the resulting structure is known as an SMA lipid particle, or SMALP, as it includes lipids from the cell membranes.

The technique was invented by Professor Tim Dafforn from the University’s School of Biosciences, who led researchers at the Universities of Birmingham and Oxford to extract what they believe is the first ever COVID-19 encounter complex with an intact membrane.

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Dr Bart Verbraeken, Business Unit Manager Orbiscope, said: “Beyond COVID-19, we believe SMAs have huge potential to unblock constrictions in the drug pipeline, by enabling studies of receptors in their native environments that will define drug targets more precisely than ever before.”

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Accurate predictions of ovarian cancer outcome possible with new classification system The new, Oxford-developed method for subtyping ovarian cancer has been validated in a recent collaboration between the University of Oxford and Imperial College London.

Dubbed the ‘Oxford Classic’, researchers have demonstrated that it enables the accurate prediction of patient disease outcome, as well as the development of new targeted cancer therapies.

Researchers have discovered and identified sub-types of ovarian cancer cells, which can then be used to accurately identify which ovarian cancer subtypes are likely to lead to more severe cancer outcomes – an approach which has been dubbed the ‘Oxford Classification of Carcinoma of the Ovary’ or ‘Oxford Classic’ for short.

The Oxford Classic, which was developed in Oxford last year, will provide much more accurate predictions for disease outcome in patients, as well as helping researchers to develop targeted therapies for each type of cancer. A study published today in Clinical Cancer Research, has demonstrated its powerful prognostic usage in a new independent set of samples from a group of ovarian cancer patients.

Serous ovarian cancer (SOC) is the most common ovarian cancer type but is challenging to classify and predict its prognosis. Using the Oxford Classic, researchers found that a specific SOC subtype, known as “EMT-high subtype”, were associated with a lower survival rate.

EMT stands for epithelial-mesenchymal transition, the process by which epithelial cells change and become more mobile. This mobility provides the cells with the opportunity to spread, leading to cancer progression.

EMT-high subtypes are tumours that have a high number of cancer cells with greater mobility.

Researchers also found that EMT-high subtypes were associated with abundance of a type of immune cells called M2 macrophage. M2 macrophages possess immunosuppressive properties, and can lead to poorer treatment responses if they are found in high quantities within a tumour. It has previously been observed that patients with high-EMT tumours had a poor immune response. This study confirms that the EMT-high subtype is associated with an immunosuppressive environment (and so poor patient responses to treatment) due to their association with more M2 macrophages – a link that has not previously been identified.

Whether M2 macrophages induce EMT or EMT results in higher levels of M2 macrophages will be an important question to be addressed by future work. However, this study has demonstrated the Oxford Classic’s strong ability to predict a patient’s prognosis.

Professor Ahmed Ahmed, of the University of Oxford’s Nuffield Department of Women’s and Reproductive Health and originator of the Oxford Classic, said, “Our group is very excited that we were able to confirm that the Oxford Classic

can predict which patients are likely to have poor outcome.

It is now important to identify new personalised therapies for the Oxford Classic-defined EMT-high ovarian cancer subtype. The finding that there is a strong connection with abundant M2 Macrophages already offers a good hint as to where we could find good treatment options for patients with this type.”

Professor Christina Fotopoulou of Imperial College London said, “This has been a very fruitful collaboration between two major UK gynaecological cancer centres; Oxford and Imperial College. We have generated very promising results towards an individualisation of care of our ovarian cancer patients. Our data will help clinicians to stratify patients to the right treatment pathway based on features of tumour biology of their disease. I hope we can continue to work together on that basis and expand and validate our data further also on a larger scale.”

Classifying the EMT status of a tumour, using the Oxford Classic, could potentially become a valuable part of future cancer stratification methods. This will ensure that appropriate treatment methods and attention are given to patients with a poorer overall prognosis.

Cary Wakefield, CEO of Ovarian Cancer Action, said, “While other cancers have achieved major improvements in treatment outcomes, ovarian cancer continues to go unrecognised, underfunded, and misdiagnosed. The Oxford classic is an exciting breakthrough that will help to identify new treatment options for ovarian cancers that have a lower chance of survival. Funding important research like this will bring us closer towards a shared goal of more women surviving ovarian cancer.”

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| arctoris |

AUTOMATED DRUG DISCOVERY PLATFORM BRINGS ABOUT PARADIGM CHANGE FOR RESEARCH Bringing a single new drug to market takes years of research and costs billions – with the COVID-19 pandemic highlighting even more how critical it is to accelerate this process. The high costs and failure rates in drug discovery can be traced down to lack of access to reliable, structured, high quality data. They are critical to power the right decisions at the right time, and to choose the right drug candidates to enter into clinical testing.

Arctoris is an Oxford-based company that just celebrated its 5th anniversary in February this year. Arctoris developed and operates Ulysses, the world’s first fully automated drug discovery platform powered by its proprietary robotic technologies. Arctoris partners with biotech and pharma companies, AI drug discovery companies as well as academic centres across the globe, delivering integrated drug discovery projects from the idea stage right up to IND-enabling studies.

Co-Founder and Chief Executive Officer Martin-Immanuel Bittner MD DPhil said: “The drug discovery ecosystem is undergoing rapid change at the moment, with an increasing focus on data quality and data capture, a core concept that in many areas has largely been disregarded in the past.”

However, two reports published by pharmaceutical companies Bayer (Germany) and Amgen (USA) sounded a wake-up call when they each concluded that between 80% and 90% of landmark studies in the field of biomedicine could not be reproduced by independent scientific teams.

When minor differences in the interpretation of protocols can account for huge differences in results, precision, consistency, and reliability become critical. The answer is automation – using robotics to conduct experiments on behalf of the human scientists, so that they can focus on higher value tasks, such as hypothesis generation, data interpretation, and project planning, all while relying on the best possible data for their decision making.

Arctoris provides just that – 24/7 automated laboratory operations, guided by an experienced team, with real-time data access for its partners and clients via its powerful digital portal, streamlining project planning, tracking and data analysis.

The wide range of biochemical, cell biology and molecular biology assays Arctoris offers enable rapid, informed decision making in basic biology, target validation, hit-tolead, lead optimisation, toxicology etc. , leading to better decisions taken earlier.

“Ulysses, the technology platform we developed at Arctoris, offers the type of precision, accuracy and reproducibility that simply cannot be obtained manually,” said MartinImmanuel Bittner. “Furthermore, thanks to fully automated experiment execution coupled with our comprehensive sensor array, we know exactly how each experiment is being conducted and how the data is being generated. We track all these parameters – the so-called experimental meta-data – throughout the whole experiment lifecycle, which enables us to provide full audit trails for each step of the process, and every dataset generated.”

Established in 2016, Arctoris grew out of the CEO’s own research experience while completing his DPhil (PhD) in Oncology as a Rhodes scholar at Oxford.

A medical doctor by background, he was surprised to see how much time researchers spent manually performing experiments, rather than discussing their ideas and focusing on the bigger picture.

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In many ways, drug research has not kept pace with other industries in employing technology to increase efficiency and speed, and the poor level of reproducibility is one of the results.

Whilst laboratory robotics have been commonplace in large pharmaceutical corporations for more than 20 years, they have almost exclusively been used solely for highthroughput screening, until recently.

Technological advances and a change in understanding over the past few years though have created a shift in the ecosystem, with more and more research leaders realising the unique benefits of automated data generation, and the impact it has on the discovery process.

The interest in automation and robotics is growing rapidly – to the same degree as Artificial Intelligence is also playing an increasing role in drug discovery. The two trends reinforce each other, as it is well known in the AI community that any algorithm can only be as good as its input data. In other words, to reap the benefits of AI-driven drug discovery, researchers have to have access to highly structured, well annotated, robust and reproducible data. “And this is what we are here for”, said Martin-Immanuel Bittner.

For more information, please visit www.arctoris.com or follow us on LinkedIn.

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Cervical cancer treatment world first at The Christie A Stockport woman is set to become the first ever patient in the world to be entirely treated for cervical cancer using a state-of-art radiotherapy treatment at The Christie NHS Foundation Trust.

“It’s also nice to know that my treatment is helping vital research for cancer patients in the future.”

Karen Hall, 57, will be treated using the MR-guided linear accelerator (MR-linac) which is the first machine of its kind to do real-time MRI scans while it targets X-ray beams at tumours, making it more accurate and reducing side effects.

Karen’s treatment is part of the MOMENTUM trial which is a worldwide radiotherapy trial using the MR-linac. It aims to target a wide range of cancers to find out which cancers react best to the treatment before it is hopefully rolled out across the globe. The trial is being overseen by Dr Cynthia Eccles and the MR-linac team at The Christie and supported by the NIHR Manchester Biomedical Research Centre.

Karen, who lives in Offerton, will be the first ever cervical cancer patient in the world to receive a full course of this type of radiotherapy at the leading cancer centre using the Elekta Unity MR-linac.

The customer services consultant was diagnosed last month after going to see her GP with symptoms in December.

Despite the COVID-19 pandemic Karen was quickly referred to The Christie in Manchester for treatment.

Being able to more specifically target tumours and avoid more healthy tissue around them means the machine can use target X-rays better. The £5.3M machine was partfunded by donations to The Christie charity.

Since the opening of the UK’s first NHS high energy proton beam centre in 2018 The Christie is now one of only two sites worldwide to offer both these pioneering radiotherapy treatments.

Karen is being treated by The Christie’s specialist gynaecological oncology team headed up by Professor Peter Hoskin, Dr Lisa Barraclough and Dr Kate Haslett.

Karen, who had only married her partner of 26 years, Dale, in September 2020, said: “It has obviously come as a bit of a shock having happened so quickly but I believe this treatment will give me a better quality of life and minimal side-effects.

“It’s been a bit of a whirlwind but considering we are in the middle of the COVID-19 pandemic I’m very grateful to have been seen and referred so quickly.

The care I’ve received has been amazing.

The MR-guided linear accelerator (MR-linac) combines magnetic resonance (MR) scanning and tumour-busting radiotherapy to deliver magnetic resonance radiotherapy in one hi-tech package.

Professor Ananya Choudhury, Clinical project lead for MRlinac, at The Christie said: “We are absolutely thrilled to be part of a world first treatment here at The Christie.

“The MR-linac has already shown to be a valuable tool in terms of radiotherapy for other types of cancers, such as prostate. It is great to be able to broaden its scope to other cancers so that we can push forward vital research and improve patient outcomes.

“In this case the MR-linac is extremely adept at treating cervical cancer because the cervix lies close to some very sensitive areas, high doses of radiotherapy risk damaging the tissue surrounding it and increase the risk of sideeffects.

“With the MR-linac we can better target the cervix while avoiding these areas, so we can safely deliver higher doses of radiation.”

The Christie NHS Foundation Trust was the first specialist trust to be rated as ‘Outstanding’ twice (in 2016 and 2018) by the health regulator the Care Quality Commission (CQC).

It referred to The Christie as ‘a leader in cancer care’ and ‘a pioneer in developing innovative solutions to cancer care.’

The CQC praised the Trust’s staff which it said ‘go the extra mile to meet the needs of patients and their families’ and that they were ‘exceptionally kind and caring.’ In 2017, the CQC rated The Christie as the best specialist trust in the country, and one of the top three trusts overall in England.

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| intellectual property |

Freedom to Operate – Understanding the Risks There are many factors to be considered for a project developing a new product or process, but the ability to carry out commercial plans without infringing third party patent rights (freedom to operate, or FTO) should not be overlooked.

Patent litigation can result in an injunction preventing access to a market plus a damages award. If a product has been on the market for several years, a damages award can be significant.

In 2016 Merck won US$2.5 billion in a patent infringement action against Gilead in relation to two Hepatitis C drugs.

However, the award was never paid as, on appeal in 2019, the patent in question was held to be invalid and, in early 2021, the US Supreme Court confirmed that decision.

In 2016 Australian hearing implant manufacturer Cochlear were ordered to pay damages of about US$268 million following patent litigation and in 2020 the US Supreme Court denied Cochlear’s petition for a review meaning that the damages have to be paid.

Although the ultimate outcomes were different, both cases no doubt caused stress for the defending companies. If such court actions are unexpected the stress is likely to be significantly greater.

For any new development project there is a possibility that a third party has rights that could limit commercial exploitation of the resulting product or process. Some companies may not consider assessing that FTO risk necessary for a project to proceed. However, the high development costs typical in the medical sector make it important to understand, and where possible reduce, such risks.

To understand FTO risks, searches can be performed to find patents that could be infringed. These searches are often referred to as FTO, or clearance, searches. The more detailed the search and review, the greater the understanding of the risk, but the costs of conducting and reviewing these searches varies significantly depending upon the level of detail. A cost effective strategy can be to conduct broad searches near the start of a project and more detailed searches as it moves forward so that the cost, and understanding of risk, is appropriate for the project stage.

A broad search at the start of a project might look at the patent landscape in the technical area. This landscape should include expired patents, as well as those that are in force. If a product is very similar to a patent that reached the

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end of its 20 year life the chances of a valid patent covering that product being in force is greatly reduced. A dense patent landscape in the technology area could indicate an increased FTO risk. A landscape search should also help to identify particular areas of the project that might be higher risk.

As the development progresses more detailed searches, focussing on particular areas of the project, can be carried out. These can be conducted on an ad hoc basis, or as part of particular project milestones, for example proof of concept or a design freeze.

If a risk is identified it is a commercial decision whether the project should proceed, but it may be possible to reduce that risk. Modifications can be made to ‘design around’ the patent so that it no longer poses a risk, but sometimes changing the design is not possible, or practical. The validity of the problematic patent can be assessed to determine whether it would survive a challenge during litigation.

The validity can be directly challenged in court to ‘clear the way’ before commercial launch. Additional searches could be carried out to find publications to support any validity challenge. Another option to remove the risk, while potentially benefitting from the protection, is to obtain a license, or purchase the patent. In general, more options are available if a potential risk is found early in a project.

“Publishing for freedom to operate” is a phrase sometimes used and it can be misleading. Publishing will not alter whether third party rights already exist that might prevent commercialisation. However, publishing will prevent a third party obtaining valid rights if they file an application after that publication. Publication cannot make the situation better, but may prevent it from becoming worse.

If you have any queries regarding this topic, or other pharmaceutical or biotechnological matters, please contact Alex Bone at amtb@aathornton.com or visit aathornton.com

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Research shows coronavirus can survive on healthcare uniforms for three days Viruses similar to the strain that causes Covid-19 can survive on clothing and transmit to other surfaces for up to 72 hours, scientists at De Montfort University Leicester (DMU) have warned.

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n a study looking at how coronavirus behaves on three fabrics commonly used in the healthcare industry, researchers found that traces can remain infectious for up to three days.

Led by microbiologist Dr Katie Laird, virologist Dr Maitreyi Shivkumar and postdoctoral researcher Dr Lucy Owen, the research involved adding droplets of a model coronavirus called HCoV-OC43 – which has a very similar structure and survival pattern to that of SARS-CoV-2, which causes Covid-19 – to polyester, polycotton and 100% cotton.

The scientists then monitored the stability of the virus on each material for 72 hours.

The results showed that polyester poses the highest risk for transmission of the virus, with infectious virus still present after three days that could transfer to other surfaces.

On 100% cotton, the virus lasted for 24 hours, while on polycotton, the virus only survived for six hours.

“When the pandemic first started, there was very little understanding of how long coronavirus could survive on textiles,” said Dr Katie Laird, Head of the Infectious Disease Research Group at DMU. “Our findings show that three of the most commonly used textiles in healthcare pose a risk for transmission of the virus. If nurses and healthcare workers take their uniforms home, they could be leaving traces of the virus on other surfaces.”

Last year, in response to the pandemic, Public Health England (PHE) published guidance stating that industrial laundering should be used for healthcare worker uniforms but where it is not possible, staff should take uniforms home to be laundered.

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In response, she advised the government that all healthcare uniforms should be laundered in hospitals to commercial standards or by an industrial laundry.

She has since co-published an updated, fully comprehensive literature review which evaluates the risk of textiles in the transmission of disease, highlighting the need to for infection control procedures when handling contaminated healthcare textiles.

“After the literature review, the next stage of our work was to evaluate the infection control risk of washing healthcare uniforms contaminated with coronavirus,” she continued. “Once we had determined the survival rate of coronavirus on each of the textiles, we turned our attention to identifying the most reliable wash method for removing the virus.”

Using 100% cotton, the most commonly used healthcare textile, the scientists conducted a number of tests using different water temperatures and wash methods, including domestic washing machines, industrial washing machines, on-premise hospital washing machines, and an ozone (a highly reactive gas) wash system.

The results showed that the agitation and dilution effect of the water in all of the washing machines tested was enough to remove the virus.

However, when the team soiled the textiles with an artificial saliva containing the virus (to mimic the risk of spread from an infected person’s mouth), they found that domestic washing machines did not fully remove the virus and some traces survived.

Meanwhile, the NHS uniform and workwear guidelines state it is safe to wash healthcare workers’ uniforms at home, provided the temperature is set to at least 60°C.

It was only when they added a detergent and increased the water temperature that the virus was completely eliminated. Investigating the tolerance of the virus to heat alone, findings showed that coronavirus was stable in water up to 60°C, but was inactivated at 67°C.

Dr Laird raised concerns that the evidence that supported the above statements was mainly based on two outdated literature reviews published in 2007.

Next, the team looked at the risk of cross contamination, placing clean items of clothing in the same wash as those with traces of the virus. They found all wash systems

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removed the virus and there was no risk of the other items being contaminated.

Dr Laird explained: “While we can see from the research that washing these materials at a high temperature, even in a domestic washing machine, does remove the virus, it does not eliminate the risk of the contaminated clothing leaving traces of coronavirus on other surfaces in the home or car before they are washed.

“We now know that the virus can survive for up to 72 hours on some textiles and that it can transfer to other surfaces too.

“This research has reinforced my recommendation that all healthcare uniforms should be washed on site at hospitals or at an industrial laundry. These wash methods are regulated and nurses and healthcare workers do not have to worry about potentially taking the virus home.”

With the support of the UK Textiles Trade Association, Dr Laird, Dr Shivkumar and Dr Owen have since shared their findings with industry experts across the UK, USA and Europe.

“The response has been very positive,” said Dr Laird.

“Textile and laundry associations around the world are now implementing our key messages in their guidance for healthcare laundering, to prevent further transmission of coronavirus.”

David Stevens, CEO of Textiles Services Association UK, the trade association for the textile care services industry, said: “Going into a pandemic situation, we had the basic understanding that textiles were not among the top transmission media for coronaviruses.

“However, we really had a lack of information about the stability of these viruses in different fabric types and in different wash programmes. This resulted in several misinformation floating around and excessive recommendations for washing.

“We have considered in detail the methodologies and research practices used by Dr Laird and her team and find this research to be reliable, repeatable and reproducible.

The conclusion of this work completed by DMU reinforces the vital role of contamination controls – whether it is domestic or industrial settings.”

To further the research, the team is also working on a project in collaboration with DMU’s Psychology team and University Hospitals of Leicester NHS Trust, surveying nurses and healthcare workers about their knowledge and attitudes towards washing their uniforms during the Covid-19 pandemic.

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Dr Katie Laird Head of the Infectious Disease Research Group at DMU

“While we can see from the research that washing these materials at a high temperature, even in a domestic washing machine, does remove the virus, it does not eliminate the risk of the contaminated clothing leaving traces of coronavirus on other surfaces in the home or car before they are washed.”

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Covid-19 transmission chains in the UK traced through time and space with remarkable accuracy using genomic epidemiology A team of scientists, led by researchers from the Universities of Oxford and Edinburgh, has analysed the first wave of the Covid-19 outbreak in the UK and produced the most fine-scaled and comprehensive genomic analysis of transmission of any epidemic to date.

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heir analysis draws on >50k virus genome sequences – 26k of which were gathered through the COVID-19 Genomics UK (COG-UK) consortium – offering a never-before-seen level of insight into the origins and behaviour of transmission chains since the start of the pandemic.

The full analysis, published today in Science, reveals that the virus was introduced to the UK well over a thousand times in early 2020 and that the rate and source of introduction changed very quickly. During this time the highest number of transmission chains were introduced from Spain (33%), France (29%), and then Italy (12%) – with China accounting for only 0.4% of imports. The study shows how the UK national lockdown affected individual transmission chains.

Corresponding and co-lead author, Professor Oliver Pybus, from Oxford’s Department of Zoology and the Oxford Martin School, said: ‘This study shows that it’s possible to trace individual virus transmission lineages accurately through time and space. Undertaking analyses on a weekly basis means that genomic tracking can become a key component of public health surveillance.’

The results offer a crucial context to what is happening now in the UK’s second wave, and the team have contributed to the identification of the new variant (termed B.1.1.7) growing rapidly in the UK. The scientists say that detailed comparison of the new variant’s behaviour with that of first wave lineages will be crucial to understanding why B.1.1.7 is spreading so quickly now.

Before the March 2020 lockdown, high travel volumes and few restrictions on international arrivals led to the establishment and co-circulation of >1000 identifiable UK transmission lineages, jointly contributing to accelerated epidemic growth that quickly exceeded national contact tracing capacity.

Professor Pybus says: ‘By reconstructing where and when COVID-19 was introduced to the UK we can see that earlier travel and quarantine interventions could have helped to reduce the acceleration and intensity of the UK’s first wave of cases.’

The team expect similar trends occurred in other countries with comparably large epidemics and high international travel volumes.

Whilst the UK national lockdown coincided with limited importation and reduced regional lineage diversity, its impact on lineage extinction was size-dependent, meaning that the largest and most widespread lineages persisted into the summer. The over-dispersed nature of SARS-CoV-2 transmission is likely to have favoured greater survival of larger, more widespread lineages and faster local elimination of lineages in low prevalence regions, highlighting the importance of rapid or preemptive interventions in reducing transmission.

The degree to which the surviving lineages contributed to the UK’s ongoing epidemic in the autumn and winter 2020, including the effect of specific mutations on lineage growth rates, is currently under investigation.

The transmission structure and dynamics measured for the first time in this study provide a new context in which future public health actions at regional, national, and international scales should be planned and evaluated.

Co-lead author, Louis du Plessis, from Oxford’s Department of Zoology, said: ‘Our work offers unparalleled views into what’s happening in an individual epidemic. The UK shares large volumes of virus genetic data publicly on a weekly basis and if you don’t have this level of surveillance you won’t know the real situation of virus evolution and transmission.’

Co-lead author, Verity Hill, PhD researcher, based at Edinburgh University, said: ‘This kind of continuous, nationally coordinated genomic sequencing not only allows the high-resolution analysis we present, but also helps other countries to place their genomic data into context and assists the global pandemic response.’

The ability to ramp up genomic surveillance at a large scale was made possible by the decision to fund the COVID-19 Genomics UK (COG-UK) consortium in April and builds on decades of blue-skies basic research into virus evolution, led by Oxford and Edinburgh universities, which developed the theory leading to scientists having these tools and theory at their disposal.

“This study shows that it’s possible to trace individual virus transmission lineages accurately through time and space. Undertaking analyses on a weekly basis means that genomic tracking can become a key component of public health surveillance.”

Professor Oliver Pybus, from Oxford’s Department of Zoology and the Oxford Martin School

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| BIOSCIENCE TODAY |

| news |

Legal Cannabis Market in Europe Set to be Worth €3.2 billion by 2025 The European cannabis market is forecast to grow with a compound annual growth rate (CAGR) of 67.4% to reach €3.2 billion by 2025, a new report has found.

The European Cannabis Report: 6th Edition, released by global cannabis industry consultants, Prohibition Partners, highlights how 60,000 people were able to access cannabis medications for the first time in Europe in 2020, bringing the total to 185,000 patients for the year.

The value of the European medical cannabis market will reach €406 million by the end of 2021: a year-onyear growth of 75% compared to 2020, according to the report’s estimates.

Germany is the medical cannabis goliath in Europe owing to progressive legislation and a large and affluent population. Germany will constitute over half of the European market until 2024 and will be worth over €840 million by the end of the forecast period. Imports of medical cannabis into the German market increased by 37% last year, bringing the total to 9.3 tonnes of product.

By 2025, countries like France and the UK will have developed patient access to medical cannabis considerably, and large European nations like these will represent a significant share of the European market, the report forecasts. If regulations continue to progress as predicted, the UK medical cannabis market could show the most significant growth of any country in Europe by 2025.

As adult-use cannabis is not yet legalised anywhere in Europe, the market for legal cannabis products in Europe remains entirely medical. This balance is expected to shift over the next four years, as more countries open up to the prospect of legalising adult-use cannabis.

Prohibition Partners’ report identifies several European nations that could introduce legal access to adult-use cannabis by 2025, including Netherlands, Switzerland

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and Germany. Sales of adult-use cannabis could be worth over €500 million by 2025.

This progression of medical and legalised adult-use cannabis will contribute to exponential growth over the next four years. By 2025, it is estimated that the European cannabis market will be worth €3.2 billion.

Stephen Murphy, co-founder and CEO of Prohibition Partners, said: “Europe is beginning to realise its potential as the world’s leading cannabis market. Since the 1st Edition of The European Cannabis Report published 4 years ago, enormous progress has been made for patient access and cannabis education. We are only at the very start of our journey of cannabis in Europe but there is irrefutable momentum towards becoming the world’s largest cannabis market, it is only a matter of time. The European Cannabis Report 6th Edition does a fantastic job informing the reader on the status of the industry in Europe, providing the context for growth and mapping out the roadmap for all stakeholders.”

Conor O’Brien, a contributor to the report and analyst at Prohibition Partners said: “The European medical cannabis market is beginning to blossom. While competition is heating up for producers and suppliers of medical cannabis in Europe, many opportunities are still open for businesses to embed themselves in niches of the value chain, before the market becomes more established. This report is designed to support businesses achieve this.”

The European Cannabis Report: 6th Edition takes an in-depth look at the progress of cannabis legalisation across Europe, the trade flows on the continent, business opportunities, medical products on the market and the patients who use them. The report also considers how COVID-19 has affected the market in Europe and what this means for the year ahead.

For more information, The European Cannabis Report: 6th Edition can be downloaded at https://prohibitionpartners.com/reports/theeuropean-cannabis-report-6th-edition/

| North-East Technology Park (NETPark) |

| BIOSCIENCE TODAY |

EXPANSION OF NETPARK OFFERS SCIENCE AND TECHNOLOGY COMPANIES ROOM FOR GROWTH The North-East Technology Park in County Durham – or NETPark as it is known – provides science, technology and engineering companies with the type of world-class laboratory, clean room and office space they require on the journey from start-up to, frequently, global AIM-listed status.

Launched in 2004, NETPark is the only science park in the UK with two Catapult Centres and three national innovations centres. It is also home to more than 32 companies which between them employ around 550 highly skilled personnel across a range of incubation and grow-on spaces, including Plexus, Discovery and Explorer.

Clear Futures, a delivery partnership that works with the public sector to make the most of its land and property assets, is working in partnership with NETPark owners Durham County Council to develop the next phase of buildings and build on the success of the science park.

Now, NETPark is expanding again to provide both grow-on space for existing tenants and new opportunities for inward investors keen to relocate their businesses to this nationally important science and technology park.

Richard Airey, director of Clear Futures, said: “The expansion of NETPark offers a unique opportunity for high growth science, engineering and technology companies to grow, scale-up and commercialise their operations at one of the UK’s premier science parks.

NETPark phase 3 will give companies planning to take that next step to significant scale-up, the option of securing a high-end premises which may be tailored to meet the most exacting of requirements.

In the well-established NETPark phases 1 and 2, the provision ranges from small incubator spaces to individual units up to 20,000sq.ft.

A new road, boasting quick access to the junction with the A177, has already been completed thanks to a £5m grant from the North-East Local Enterprise Partnership, in keeping with the Government’s North-East Growth Deal. The road has been crucial in opening up the land for development.

Phase 3 will be designed to be equally flexible including space for bespoke buildings potentially up to 70,000sq.ft and beyond.

The location of NETPark is a key attraction being in the heart of the countryside, yet just 20 minutes from Durham and a stone’s throw from major transport arteries.

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| BIOSCIENCE TODAY |

| North-East Technology Park (NETPark) |

“It is set in a really lovely environment, something businesses feel is as important as its great connectivity,” said Richard.

“We aim to keep the rural feel of the site, which offers access to lots of great outdoor activities, such as walking and cycling along existing networks. They are of tremendous benefit to the people working here.”

One of the companies that has been growing at NETPark since 2012 is Redditch Medical, supplier of medical devices and specialised pharmaceutical products to healthcare services across the globe.

The company occupies the Discovery 2 building, which is dedicated to the manufacture of GMP pharmaceutical products and incorporates a class 6 cleanroom James Tucker, sales and marketing director for Redditch Medical, said: “The incentives offered made it a no-brainer to set up here, and particularly given the strength of the chemical and life sciences industries and networks in this area.

“The ability to dip into different resources, in terms of labour and some of the innovation and technology that is happening round about, is very important to a business such as ours.”

“The expansion of NETPark offers a unique opportunity for high growth science, engineering and technology companies to grow, scale-up and commercialise their operations at one of the UK’s premier science parks.”

Richard Airey, director of Clear Futures

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The availability of a skilled local workforce has contributed significantly to the success of the operation based at NETPark. Essentially a start-up in 2012, it now accounts for 50% of the company’s annual turnover.

“So yes, it has been a huge success story for us,” said James. “A large portion of Redditch Medical’s output goes for export. We’re not just manufacturing for the UK, we are servicing vaccine manufacturers and pharmaceutical companies world-wide. We are now exporting to Australia, central Europe, Asia and some into the USA too.”

Its own services were predicated by customer demand and the determination to close any gaps in the market in relation to service, product and supply. “Today, we have the largest range of offer within the segment/industry,” he said.

The 40 or so members of staff based at Redditch Medical’s offices on NETPark were perfectly placed to carry out their key roles in production, quality control and logistics.

Find out more about NETPark at www.northeasttechnologypark.com, telephone +44(0)1740 625250 or on Twitter @NETParkUK.

| BIOSCIENCE TODAY |

| news |

SCOTTISH BIOTECH COMPANY SECURES FUNDING FOR NEW CORONAVIRUS RESEARCH Company’s R&D programme expanded with additional focus on antiviral properties of cyanobacteria Industry and academia collaboration funded by Medical Research Scotland ScotBio, a fast growing Scottish biotech business, is expanding its R&D programme to explore the potential of cyanobacteria to treat emerging viral pathogens, including coronaviruses.

The company, which is currently using its extensive biotechnology expertise to mass produce natural ingredients and colourants from cyanobacteria for the food industry, is now looking at how its advanced technical skills and production processes could be used in the creation and manufacture of treatments for current and future virus pandemics.

With funding from Medical Research Scotland, a new collaborative partnership with Infection Medicine at the University of Edinburgh will investigate how cyanobacterial extracts, recognised previously for their antiviral activity, can be commercially mass produced using ScotBio’s established production processes and used in the treatment of major emerging viral diseases. The award of over £100,000 will fund a PhD project which will run for a four-year period.

Infection Medicine is a multi-disciplinary centre at the University. Host-pathogen interactions is a key research theme of the centre, which investigates host-pathogen interactions that are vital to our understanding of host biology, infectious diseases and effective therapies.

Dr Richard Sloan, a Lecturer in Infection Medicine at the University of Edinburgh said: “The current coronavirus pandemic has unfortunately shown that there is a deficit of ‘on the shelf’ antiviral compounds with broad activity against a range of viruses. These viral outbreaks are unfortunately normal, and to be expected, so it is important that this therapeutic deficit is addressed.

“Past research already indicates activity against ‘families/ groups’ of viruses likely to cause outbreaks or pandemics, including influenza and coronaviruses. With this ScotBio collaboration we will go one step further determining specific action against, for example SARS-CoV-2 or MERS.” Dr Rocky Kindt, Chief Technical Officer at ScotBio said “Ironically it was during the original lockdown in March 2020, when some of our current work had been put on an enforced pause, that our team of scientists spent time reviewing their own work and other scientific literature and they identified significant antiviral potential in cyanobacteria.

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“Cyanobacteria are used in commercial production of a range of products such as food colourants and vegan proteins as well as therapeutic applications however it is known that antiviral molecules can be extracted from them too. Previous research on common viruses describe how cyanobacterial extracts can interfere with viral transmission or serve to modulate the host immune response, however, their specific role against emerging viral pathogens likely to cause pandemics will now be investigated in more detail.

“The overall aim of this new research project with the University of Edinburgh is to identify the antiviral therapeutics that can be extracted from cyanobacteria and subsequently devise methods for their commercial mass production. It is something that we are all very excited about.”

The research project will formally begin at the University of Edinburgh in September 2021 and will last up to four years but ScotBio has already begun accelerating its in-house research to make sure that when the project begins it will already be at an advanced stage.

Polly Van Alsytne, Chief Operating Officer at ScotBio added: “At the moment virtually all commercial production of cyanobacteria is via outdoor cultivation which can be held back by inherent variability, scalability, and quality issues which means it prohibits any supply into the pharmaceutical industry. Our unique production processes are all carried out indoors in purpose built tanks resulting in intensive, closed, and hygienic production all year round irrespective of climate or season thus addressing the concerns of the pharmaceutical sector.

“As well as the technical and scientific skills and knowledge in this field, our current work in mass producing natural ingredients and colourants from cyanobacteria for the food industry means that we have the production capability and understanding of the required processes, and would have sufficient volume of the required biomass needed to mass produce antiviral products.”

Professor Philip Winn, Chair of Medical Research Scotland said: “ScotBio has a strong track record of collaborating with academia to further existing research and to look at ways of successfully commercialising that knowledge. This new project has heightened importance as the world continues to face the challenge of coronaviruses.”

| diagnostics |

| BIOSCIENCE TODAY |

COVID-19 TESTING SECTOR DEMAND SET TO CONTINUE AMID VACCINE ROLLOUT Amid the continued high demand for testing and staggered vaccine rollout, the diagnostics industry, which was valued in 2020 at $17.2bn-$19.8bn, is set to rise further in 2021

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| BIOSCIENCE TODAY |

| diagnostics |

The diagnostics sector will continue to see growth in 2021 as demand for COVID-19 testing continues to surge. It has been suggested that to ensure effective disease control, the UK alone would require 120m tests per month. Global demand exceeds supply, providing opportunities for existing diagnostics providers and newcomers alike. The diagnostics sector remains a high-growth area, at a time when most other sectors are experiencing disruptions due to the pandemic.

These are the findings of finnCap’s new quarterly Life Sciences sector report, ‘Rude Health: COVID-19 Diagnostics’.

COVID-19 testing is likely to peak in 2021 but will continue to see strong demand into 2022 and beyond as a result of the logistical hurdles in vaccinating the global population as well as the uncertainty around how long vaccine jabs provide immunity and their effectiveness against new COVID strains.

The report looks at the different types of COVID-19 diagnostic technologies and the companies utilizing them.

PCR testing is the most common type of testing, providing the highest levels of accuracy, but carries the downsides of being expensive and requiring experienced professionals, with results that can days to process depending on the lab. Companies offering or developing PCR tests include Novacyt, Yourgene and genedrive.

Lateral Flow Diagnostics, on the other hand, can provide cheap and rapid results (within 15 minutes) and can be administered without training, but are not as accurate as other technologies. Companies offering/developing COVID-19 lateral flow diagnostics include Avacta, MologicOmega Diagnostics and Immunodiagnostic systems.

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The report also highlights two less well-known processes – the ELISA (enzyme linked immunosorbent assays) being utilised by companies such as EKF Diagnostics and LAMP (loop mediated isothermal amplification) being ultilised by companies such as OptiGene.

The demand for testing is so high that all processes, regardless of their specific advantages and disadvantages will continue to be needed over a busy 2021. FinnCap highlights AIM listed and private companies, Avacta (AVCT), Novacyte (NCYT), Omega Diagnostics (ODX), genedrive (GDR) and OptiGene among them, and discusses the technologies they have employed and the tests that they have developed or are developing.

In addition, the report also looks at the performance of the AIM life sciences sector, which outperformed larger-cap and health indices and other sectors in 2020, boosted by COVID-19 testing stocks, which will place it in a strong position for 2021. £1.039bn was raised for the life sciences sector on the AIM Index over 2020, a leap on the £242mn raised over the same period in 2019.

Arshad Ahad, Research Analyst, Life Sciences, at finnCap, commented: “The COVID-19 diagnostics sector was at the forefront of international attention in 2020 as the primary weapon to fight the pandemic. The encouraging progress on vaccines has prompted fears over the sustainability of this market; however, we believe these fears are unwarranted.

We believe the market has yet to peak and will do so in 2021, but will remain strong into 2022 and beyond. Overall, it is likely that COVID-19 will be a part of our lives for years to come and may even be a perpetual presence – and as long as this remains the case, COVID-19 testing will be an important tool for keeping the disease in check and avoiding outbreaks.”

| diagnostics |

| BIOSCIENCE TODAY |

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Pioneering technique paves way for fast and cheap fabrication of rapid medical diagnostic tools Breakthrough promises to democratise microfluidics and lab-on-a-chip technology, benefiting resource-poor countries and settings.

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| BIOSCIENCE TODAY |

| diagnostics |

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New technology developed by the University of Bristol has the potential to accelerate uptake and development of onchip diagnostic techniques in parts of the world where rapid diagnoses are desperately needed to improve public health, mortality and morbidity.

Microfluidic devices underpin lab-on-a-chip (LOC) technologies which are developed to provide the rapid diagnoses at that are needed at point of care (POC) for the swift and effective treatment of many diseases.

1 100-micron wide 3D-printed microchannel scaffolds, shown next to a 20p coin - the cost to print 1000 of these channels

2 Simplified flowdiagram of the low-cost technique for fabricating microfluidic devices. Resulting channels can be applied directly to a glass surface with no additional treatment.

Researchers at Bristol have developed a fast, reliable and cost-effective alternative for producing the soft-lithographic moulds used for fabricating microfluidic devices, published in the journal PLOS ONE. This discovery means fabrication of microfluidic devices (with channel dimensions ~width of a human hair) is now both accessible and affordable using simple, low-cost 3D-printing techniques and the opensource resources developed by the team.

“Previously, techniques for producing the soft-lithographic scaffolds/moulds (microfluidic channel patterns) were timeconsuming and extremely expensive, while other low-cost alternatives were prone to unfavourable properties. This development could put LOC prototyping into the hands of researchers and clinicians who know the challenges best, in particular those in resource-limited settings, where rapid diagnostics may often have the greatest impact,” said lead author of the study, Dr Robert Hughes.

“This technique is so simple, quick & cheap that devices can be fabricated using only everyday domestic or educational appliances and at a negligible cost (~0.05% of cost of materials for a single microfluidic device). This means researchers and clinicians could use our technique and resources to help fabricate rapid medical diagnostic tools, quickly and cheaply, with minimal additional expertise or resources required,” said co-author, Mr Harry Felton.

“The simplicity and minimal cost of this technique, as well as the playful click-and-connect approach developed, also makes it suitable for hobbyists and educational use, to teach about microfluidics and the applications of lab-on-a-chip technology,” said co-author Ms Andrea Diaz Gaxiola.

“It is our hope that this will democratise microfluidics and lab-on-a-chip technology, help to advance the development of point-of-care diagnostics, and inspire the next generation of researchers and clinicians in the field,” said Dr Hughes.

The next step for the team is to identify potential collaborators in both research and education to help demonstrate the impact this technology could have in both settings by developing and supporting outreach activities and applications for on-chip diagnostic testing.

Paper: ‘Negligible-cost microfluidic device fabrication using 3D-printed interconnecting channel scaffolds,’ by Felton, H., Hughes, R., & Diaz-Gaxiola, A., in PLOS ONE.

3 Dye-mixing inside a microfluidic chip made using 3D-printed interconnecting channel scaffolds prints

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| innovation |

| BIOSCIENCE TODAY |

What makes a spinout?

Universities carry out research into some of the most fundamental questions about life and the world around us, with researchers utilising specialist facilities and equipment to investigate and advance human knowledge.

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| BIOSCIENCE TODAY |

| innovation |

T

his doesn’t happen overnight, and there is inherently a level of risk involved in carrying out new research.

Not every experiment is successful, and sometimes, it can take years to reach the conclusion that a new idea is wrong. Sometimes, it takes much longer than originally planned for a new theory to be proven one way or another.

But, sometimes, something entirely new is identified or created through research.

Those advances can transform lives. For example, by establishing a potential new way to treat a life–limiting disease, potentially unlocking a better quality of life for patients.

While the breakthrough is highly significant, the university still needs to find the best way possible to enable its research to benefit patients. And that’s where commercialisation and spinouts can come in.

Dr Anne Lane is CEO of UCL Business, the commercialisation company for UCL, one of the world’s leading multi-disciplinary universities.

“When our university’s researchers are on the path to creating or finding something new with significant potential, that’s where we can come in and help. Firstly, we help our researchers to protect their intellectual property (IP), including through patenting. It’s very important to ensure that IP is protected because it means it is defensible and cannot be copied.

Breakthrough research can cost a lot in resources, but also personal commitment, and it’s important that this isn’t something that can be easily copied.” says Anne.

With the IP protected, UCLB’s staff then help the university and its researchers to consider the best way to make an impact from their work. Sometimes, the best way forward is to sell or license the IP to an existing organisation, which is well positioned to take it forward quickly. For example, because it already has the manufacturing processes or expertise required, or products in complementary areas already.

But sometimes, the new IP is strong enough to standalone and drive the formation of an entirely new company, and this is known as a ‘spinout’. In this case, the new spinout company will seek to take the IP forward and deliver new products and services that utilise it.

There are some significant advantages to doing this, including the ability for the researchers involved in the breakthrough research to keep more control over its destiny, and to keep developing it and building on its success over time. And, it may result in greater financial returns for those involved, and ensure the product finds it ways to those it would help most faster and more effectively.

“While not suitable for every opportunity, spinouts can be one of the most effective ways of taking forward pioneering new IP – like new therapies, or new medical equipment for example – because they enable an organisation to be set up with the sole intent of bringing it to market. It can potentially mean that research finds its way to making an impact on patients’ lives much faster than relying on external partners to do so. It can take investment from the university, and external partners like venture capital and medical charities to achieve this, but the results are often truly lifechanging.” says Anne.

NovalGen is a UCLB spinout that is looking to do just that.

Its first pipeline product is a proprietary T Cell engager therapy that safely harnesses the immune system to fight cancers. Its lead program, called NVG-111, enters the clinic in the first half of 2021 and is capable of targeting over 20 different hard to treat cancers. NVG-111 is a first in class bispecific antibody T cell engager targeting Receptor tyrosine kinase-like orphan receptor 1 (ROR1)

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Dr Anne Lane

When our university’s researchers are on the path to creating or finding something new with significant potential, that’s where we can come in and help.

Firstly, we help our researchers to protect their intellectual property (IP), including through patenting. It’s very important to ensure that IP is protected because it means it is defensible and cannot be copied.

The company is starting their clinical studies in Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, utilising IP that was licensed from research originally carried out at UCL. It has a focus on breakthrough bispecific antibody therapies harnessing the immune system to fight cancer To do that, it has assembled a dedicated and expert team of experienced scientists, physicians and professionals.

“NovalGen is a great example of why a spinout can be the right route forward. It is supported by a foundation of outstanding UCL research into potentially lifechanging bispecific therapies and has been established with a very clear vision and purpose to improve the lives of patients.” commented Anne Soon, NovalGen aims to take the next step forward, with the first ever clinical trials of its new ROR1 T Cell engager therapy in a cancer patient. The results of those trials play a vital part in enabling spinouts like Novalgen to gain regulatory approval for new therapies and bring treatments to patients who badly need them.

Through spinouts, research that’s underway in universities today can make a big difference to the therapies available in our healthcare systems tomorrow. www.uclb.com

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| BIOSCIENCE TODAY |

| news |

RCSI researchers discover new way to halt excessive inflammation RCSI researchers have discovered a new way to ‘put the brakes’ on excessive inflammation by regulating a type of white blood cell that is critical for our immune system.

The discovery has the potential to protect the body from unchecked damage caused by inflammatory diseases.

The paper, led by researchers at RCSI University of Medicine and Health Sciences, is published in Nature Communications.

When immune cells (white blood cells) in our body called macrophages are exposed to potent infectious agents, powerful inflammatory proteins known as cytokines are produced to fight the invading infection. However, if these cytokine levels get out of control, significant tissue damage can occur.

The researchers have found that a protein called Arginase-2 works through the energy source of macrophage cells, known as mitochondria, to limit inflammation. Specifically they have shown for the first time that Arginase-2 is critical for decreasing a potent inflammatory cytokine called IL-1.

This discovery could allow researchers to develop new treatments that target the Arginase-2 protein and protect the body from unchecked damage caused by inflammatory diseases.

“Excessive inflammation is a prominent feature of many diseases such as multiple sclerosis, arthritis and inflammatory bowel diseases. Through our discovery, we may be able to develop novel therapeutics for the treatment of inflammatory disease and ultimately improve the quality of life for people with these conditions,” commented senior author on the paper Dr Claire McCoy, Senior Lecturer in Immunology at RCSI. The study was led by researchers at the School of Pharmacy and Biomolecular Sciences, RCSI (Dr Claire McCoy, Dr Jennifer Dowling and Ms Remsha Afzal) in collaboration with a network of international researchers from Australia, Germany, and Switzerland.

The research was funded by Science Foundation Ireland, with initial stages of the research originating from a grant from the National Health Medical Research Council, Australia.

“Excessive inflammation is a prominent feature of many diseases such as multiple sclerosis, arthritis and inflammatory bowel diseases. Through our discovery, we may be able to develop novel therapeutics for the treatment of inflammatory disease and ultimately improve the quality of life for people with these conditions.” Dr Claire McCoy, Senior Lecturer in Immunology at RCSI 31

| storage and logistics |

| BIOSCIENCE TODAY |

CRYONISS EARNS COVETED MHRA QUALITY MARK

Experts in biological sample, and medicinal product, storage and logistics management, CRYONISS offers a comprehensive storage service from ambient down to vapour phase liquid nitrogen.

The Cheshire-based team has a wealth of experience in supporting drug discovery projects, from early stage target identification through to clinical trials and life cycle management.

It is capable of storing any vaccine at any temperature required, including an ultra-low temperature product such as Pfizer-BioNTech’s Covid jab at the headline-grabbing minus 70 degrees.

Now Cryoniss has won MHRA approval, the gold mark that confirms its ability to accompany clients on the whole journey from research to commercialisation and beyond.

Business Development Manager Olivia Turner, who is the final weeks of a biomedical science degree and has a special interest in vaccines, said: “Our role will be to support the cold chain, the route of delivery from manufacturer to patient. Often that is literally a chain of freezers, used to store vaccines at the correct temperature so they don’t degrade and lose efficacy.

Chief Executive Sonia Houghton said: “From pre-clinical to clinical sample storage and now actual medicinal drug storage, we can partner with them throughout the life-cycle of a procedure - and that is exactly where we wanted to position ourselves.”

The hard-won quality mark was awarded after the final round in which Sonia in particular was examined by the Medicines and Healthcare products Regulatory Agency on every aspect of the business, from her own personal knowledge of the regulations to the quality management and emergency back-up systems in place. The interview took four hours.

Over the course of the previous three months, Cryoniss also submitted the 170 or so documents required to demonstrate thorough quality assurance.

However, thanks to the hard work of the Cryoniss team and particularly QA Consultant Anna Kozaczek, Cryoniss passed with flying colours.

With confirmation its facilities and business continuity management system are perfectly aligned with vaccine storage regulations, the company is ready to step into that particular breach.

“At the minute, Covid vaccines are being transferred directly to clinics to meet current demand, but eventually they will be transferred to clinical storage hubs such as ours to hold until they are needed.”

When vaccines were stored it was in their undiluted form, she added. It was only when the stock was delivered to a clinic, thawed and diluted, that the clock started to tick on the shelf life of a vaccine.

Each vaccine had a different storage requirement and a different shelf-life. “The AstraZeneca Covid vaccine only needs to be stored at between two and eight degrees, which massively reduces both the complexity of the cold chain required and any mistakes that could be made,” said Olivia.

“It is much more difficult to maintain the ultra-low temperatures such as minus 70 and some countries might not be able to afford the number of freezers and level of transport needed to store and distribute, say, the Pfizer vaccine.

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| BIOSCIENCE TODAY |

| storage and logistics |

“At our end of things, we need to be aware of the logistical challenges as we send the vaccines on.”

Sonia Houghton herself is not only an experienced research scientist, but while working for AstraZeneca, she also established and managed a first class internal service providing next day delivery of qualified cell lines to its scientists - wherever they were based.

By the time she launched Cryoniss, in early 2019, she was an expert in providing contract services to research, pharmaceutical and biotech enterprises all over the world.

Cryoniss now has two storage facilities - one at Alderley Park and the other on Runcorn’s Heath Business and Technical Park - that between them can hold more than a million samples, from room temperature down to vapour phase liquid nitrogen (minus 196°C).

And it has the strategic capability necessary to distribute cell lines and vaccines alike. Sonia said: “Logistics is end-to-end cold chain storage and that is a major part of what we do. Due to Brexit, there is suddenly a huge demand for our services - our contract numbers are going through the roof!

“A lot of companies are struggling to cope with the changes now that we are subject to Third Party regulations, particularly if their researchers use animal by-products, which causes many more issues getting the product into the EU. “But my team and I have long experience in importing and exporting all over the world, so we are well used to overcoming the hurdles presented by Third Party status.”

The team has worked hard to turn Cryoniss into a one-stop shop capable not only of storing investigative and medicinal products, but of sending them onwards, too, in a safe, tracked and traced manner.

Because every single aspect of what they do can be tailored to meet specific requirements, the team can also be invited into a trial or procedure relatively late in the day, for example when they are supporting the work of a laboratory offering a toxicology testing service.

Whatever the scenario, Cryoniss is ready to respond at any point throughout the lifecycle of a research project and, now, the distribution of a vaccine. “Research to commercialisation and beyond,” said Sonia. www.cryoniss.com

“From pre-clinical to clinical sample storage and now actual medicinal drug storage, we can partner with them throughout the life-cycle of a procedure - and that is exactly where we wanted to position ourselves.” Sonia Houghton, Cryoniss chief Executive 33

| vaccines |

| BIOSCIENCE TODAY |

UK Government invests £5m to develop ‘library’ of mRNA vaccines CPI has received a £5 million investment to support the development of an mRNA ‘vaccine library’ as part of the Government’s vaccine support package announced in the Budget by the chancellor, Rishi Sunak.

The vaccine library will form the basis of a rapid response facility, which will enable mRNA vaccines to be developed to help protect against new variants of COVID-19 as and when they emerge. As COVID-19 is such a new virus and vaccines have been developed at-speed over the past year, it is unclear how effective they may be against new variants.

Research is ongoing into their effectiveness, and although experts believe the current vaccines will combat the recently identified Kent, Brazil and South African strains of the disease, new variants will likely continue to emerge in the future that are resistant, which means new vaccines will be needed.

When new variants of COVID-19 are identified, their DNA can be used to develop mRNA vaccines in a matter of days.

The vaccines will be banked in a ​‘vaccine library’, ready for future manufacture and scale-up when needed.

CPI, part of the High Value Manufacturing Catapult, has been working with the UK Vaccine Taskforce (VTF) since March 2020, applying its world-leading expertise in the development of mRNA vaccines to support the fight against coronavirus. CPI is currently the only company based in the UK capable of batch developing mRNA vaccines ready for use in clinical trials and manufacture.

CEO Frank Millar said: “We’re delighted to be a key part of the UK’s ongoing fight against coronavirus, which has had such a devastating impact over the past year. It’s essential that we prepare for a future living with the threat of COVID-19 and the library of vaccine candidates we are building here in Darlington will help future-proof against further outbreaks caused by new strains of the disease.

It will mean that as soon as a new strain of COVID-19 is identified, the relevant vaccine can be selected and rapidly manufactured for use in clinical trials, in a very similar way that we see flu vaccines developed each year.”

The North East of England has proven to be a powerhouse in the UK life sciences sector following a decade of investment through the UK industrial strategy, which set out to build skills and infrastructure to support high-value industries. One-third of the UK’s GDP in pharmaceutical manufacturing comes from the North East and the Fujifilm facility in Billingham is manufacturing the Novavax COVID-19 vaccine.

This latest investment demonstrates the global importance of the world-leading science and innovation developed here in the UK.

“We’re delighted to be a key part of the UK’s ongoing fight against coronavirus, which has had such a devastating impact over the past year. It’s essential that we prepare for a future living with the threat of COVID-19 and the library of vaccine candidates we are building here in Darlington will help future-proof against further outbreaks caused by new strains of the disease.” Frank Millar, CEO CPI 34

| BIOSCIENCE TODAY |

| vaccines |

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| national horizon centre |

| BIOSCIENCE TODAY |

Delivering real impact to the world of bioscience Since it opened in 2019, the National Horizons Centre has quickly established itself as a vital linchpin helping drive forward the life sciences sector across the UK. Through research, partnerships and training , the National Horizons Centre, a £22.3 million national centre of excellence for the bioscience industries based at Central Park, Darlington, is working to develop the capacity of the life sciences sector, encouraging innovation and supporting industry with its world-class facilities.

The NHC was founded in conversation with, and for the bioindustry, to discover diseases earlier, develop novel treatments, and deliver life changing medicines to those in need, quicker, safer and more affordably.

Its key strengths include disease specific research to understand the biology of diseases; biomanufacturing to develop and deliver faster, safer and more affordable treatments; and, digital analytics and machine learning to utilise the latest technology in the discovery, development and delivery of life changing medicines.

Over the six months, since the new director, Dr Jen Vanderhoven arrived, this has been evidenced in a variety of ways; from helping train the region’s vaccine manufacturing workforce to collaborating with industry to increase process productivity.

VITAL VACCINE TRAINING The National Horizons Centre is to play a pivotal part in training the future vaccine manifesting workforce as the country battles back against the COVID-19 pandemic.

Sixty-million doses of the Novavax vaccine are being manufactured in Stockton-on-Tees by FUJIFILM Diosynth Biotechnologies (FDB), with the National Horizons Centre helping train their expanding workforce. The NHC is delivering a bespoke training course for new FDB staff looking at the latest development in biologics and imparting the necessary skills to carry out process development and manufacturing of vaccines and other life saving medicines.

The National Horizons Centre is also exploring more ways which it can use its state-of-the-art facilities and expertise to support the nations vaccine manufacturers, with skills development as it continues its integral role in the pandemic ecosystem.

As well as loaning vital equipment to NHS trusts, the National Horizons Centre is part of a study working with clinicians from local NHS Trusts to understand the clinical course of COVID-19 cases in the region and in other countries to understand risk factors and guide treatment strategies.

In parallel, the team is investigating underlying aspects such as respiratory disease and the cytokine storm that can prove

a disastrous turning point not just in Covid-19, but other diseases too.

DEVELOPING A BIOSCIENCE HUB The National Horizons Centre’s partnership with FDB to grow the skills capacity of the vaccine manufacturing workforce is part of a wider collaboration to grow the bioscience sector in the Tees Valley region.

Alongside FDB and CPI, the NHC is a founding member of the Northern Bio-Accelerator Partnership, which has created a bioprocessing, biomanufacturing and biopharmaceutical hub and position the North East as a centre of innovation, attracting investment, enhanced education and workforce development, and ultimately enabling more companies to bring life changing medicines to market faster.

Each organisation brings unique expertise to the partnership, with a proven track record of collaboration.

The National Horizons Centre, provides the academic and skills aspect, offering industry-specifc scientifc expertise, driving basic and applied research, and providing workforce training and development.

Tees Valley Mayor Ben Houchen said: “Our region is becoming one of the best places in the world for science, innovation and jobs of the future, and this is down to

36

| BIOSCIENCE TODAY |

| national horizon centre |

Steve Bagshaw CBE, Chief Industry Adviser to the NHC the fantastic work being done behind the scenes at the National Horizons Centre, CPI and FUJFILM Diosynth Biotechnologies.

“It is because of nationally signifcant partnerships like this that we can continue to punch above our weight as a region and attract the jobs, businesses and investment to the North East.”

DELIVERING ADVANCED TRAINING The selection of the NHC as one of three UK National Training Centres for the Advanced Therapies Skills Training Network (ATSTN) further cements the NHCs expansive capabilities, and the region’s growing reputation as a global hub for the bioscience sector.

The NHC will deliver high impact hands-on training courses as part of the growing ATSTN programme, expanding on its already existing industry focused training programmes.

ATSTN is a nationwide skills development programme funded from the Department for Business, Energy & Industrial Strategy (BEIS) and Innovate UK (IUK) delivered through the Cell and Gene Therapy Catapult.

OVER THE NEXT FIVE YEARS, THE NATIONAL HORIZONS CENTRE WILL INVEST MORE THAN £2.5MILLION TO MEET ITS AIMS.

Matthew Durdy, Chief Executive Officer at Cell and Gene Therapy Catapult, said: “The involvement of the National Horizons Centre will enable the ATSTN to provide users with a wide variety of exciting training resources which are at the forefront of innovation. I look forward to witnessing the impact which the NHC will make as part of this valued collaboration over the years to come.”

As part of the ATSTN, the National Horizons Centre will also create a virtual reality training facility.

This will build upon ground-breaking work to develop innovative technological methods to improve productivity and training in the bioscience sector.

The National Horizons Centre team has created a realistic virtual learning environment to simulate the operation of a biomanufacturing plant and actively engage with virtual emergency scenarios.

Additional work includes the development of an Artificial Intelligence module which can track a user’s performance to monitor and assess training needs across individuals and user groups.

37

AN EXCITING FUTURE A panel of leading industry experts has given its wholehearted support to the centre’s ambitious fve-year business plan which aims to signifcantly grow the skills and capacity of the UK’s bioscience industry and includes the recruitment of 15 senior staff and academics.

Members of a bioscience industry workshop featuring leaders from national and international organisations agreed that the exciting vision would provide a rich pipeline of graduate talent to the life sciences sector while helping to grow the UK bioindustry through industry-focused training, research and partnerships.

Over the next fve years, the National Horizons Centre will invest more than £2.5million to meet its aims.

Investments include the recruitment of 15 new staff including four senior academics at Professor level specialising in Proteomics, Translational Healthcare, Gene Therapy and Cell Engineering, as well as a senior technician, experimental officers and a business development manager.

By the end of the five year-plan, up to 50 percent of the National Horizons Centre’s output will be focused towards industrial collaboration and training.

The NHC also plans to develop key collaborations and strengthen the existing synergies between organisations at Darlington Central Park to ensure it continues to grow as a leading centre for bioprocessing and biopharma, attracting even more talent and investment.

Steve Bagshaw CBE, Chief Industry Adviser to the NHC and chairman and former chief executive of FUJIFILM Diosynth Biotechnolgies, said: “Since opening in 2019, the NHC has already made a huge impact helping to grow the life sciences ecosystem here in the Tees Valley and developing the skills and talent needed for the jobs of the future.

“These plans will build on these considerable achievements and this endorsement by industry peers are testament to the approach that the NHC has taken to ensure it is constantly working in partnership with and responsive to the demands of the sector.”

For more information visit www.tees.ac.uk/nhc

JOIN OUR TEAM The National Horizons Centre (NHC) is a £22m centre of excellence for the bioscience industries. Together with our partners, we pride ourselves on discovering diseases earlier, developing novel treatments and delivering life-saving medicines quicker, safer and affordably.

We all deserve a bright future.

No one should be priced out of life.

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I work at the National Horizons Centre to improve cancer diagnosis and develop kinder treatments for children and adults.

I work at the National Horizons Centre to lower the cost of manufacturing medicines and bring them to you faster, safer and cheaper.

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| BIOSCIENCE TODAY |

| news |

INEOS donates £100m to new institute designed to fight antimicrobial resistance A new state of the art institute for antimicrobial research is to open at Oxford University thanks to a £100 million donation from INEOS. INEOS, one of the world’s largest manufacturing companies, and the University of Oxford are launching a new worldleading institute to combat the growing global issue of antimicrobial resistance (AMR), which currently causes an estimated 1.5 million excess deaths each year- and could cause over 10m deaths per year by 2050. Predicted to also create a global economic toll of $100 trillion by midcentury, it is arguably the greatest economic and healthcare challenge facing the world post-Covid.

It is bacterial resistance, caused by overuse and misuse of antibiotics, which arguably poses the broadest threat to global populations. The world is fast running out of effective antibiotics as bacteria evolve to develop resistance to our taken-for-granted treatments. Without urgent collaborative action to prevent common microbes becoming multi-drug resistant (commonly known as ‘superbugs’), we could return to a world where taken-for-granted treatments such as chemotherapy and hip replacements could become too risky, childbirth becomes extremely dangerous, and even a basic scratch could kill.

The rapid progression of antibacterial resistance is a natural process, exacerbated by significant overuse and misuse of antibiotics not only in human populations but especially in agriculture. Meanwhile, the field of new drug discovery has attracted insufficient scientific interest and funding in recent decades meaning no new antibiotics have been successfully developed since the 1980s.

The new INEOS Oxford Institute will benefit from the internationally outstanding facilities and expertise of Oxford University, which played the key role in the origin of antibiotics following Fleming and Oxford’s discovery and development of penicillin in the last century. The IOI will create collaborative and cross-disciplinary links across the sciences, and will be based between two sites in Oxford, linking the University’s Department of Chemistry with the new Life & Mind Building, which is currently under construction.

Prolonging the benefits of antibiotics the world has known since the 1940s requires both urgent new drug development, and better management of the existing drugs we have. It is natural that the microbes causing illness and infection gradually evolve to evade our treatments, but misuse of antibiotics - for instance overusing them and not

39

finishing a full prescribed course - drastically accelerates this process.

The majority of global antibiotic consumption by volume is used for agriculture, and drug use in animals is contributing significantly to their lessening effectiveness in humans.

The INEOS Oxford Institute for AMR Research (IOI) will therefore focus on designing novel antimicrobials just for animals, as well as exploring new human drugs.

Alongside its drug discovery work, the IOI intends to partner with other global leaders in the field of Antimicrobial Resistance (AMR) to raise awareness and promote responsible use of antimicrobial drugs. The academic team will contribute to research on the type and extent of drug resistant microbes across the world, and critically, will seek to attract and train the brightest minds in science to tackle this ‘silent pandemic’.

Professor Louise Richardson, Vice Chancellor of the University of Oxford, said: “This is a wonderfully generous gift for which we are very grateful. It is another example of a powerful partnership between public and private institutions to address global problems. Oxford played a crucial role in the early development of antibiotics so it is only appropriate that we take the lead in developing a solution to antimicrobial resistance.”

Sir Jim Ratcliffe, Chairman of INEOS said: “Innovative collaboration between industry, academia and government is now crucial to fight against AMR. INEOS in its 22 years has become the largest private company in the UK, delivering large-scale, ambitious technical projects with impactful results. We are excited to partner with one of the world’s leading research universities to accelerate progress in tackling this urgent global challenge.”

Surgeon David Sweetnam, Adviser to the INEOS Oxford Institute, said: “The growing menace of bacterial resistance to antibiotics is one of the most underreported issues of our time. All modern surgery and cancer treatments rely on the use of effective antibiotics. To lose this precious gift will signal a return to a pre-antibiotic era. We now have a very narrow window of opportunity in which to change course and prevent the unthinkable from becoming the inevitable.

The donation by INEOS is one of the largest ever given to a UK University, and builds on the company’s long commitment to philanthropy in the public health space.

INEOS has already funded initiatives such as The Daily Mile, which aims to get the world’s children active every day, to tackle obesity and improve health and wellbeing.

| kolabtree |

| BIOSCIENCE TODAY |

Clinical trials for gene and cell therapies In early 2020, the Cell and Gene Therapy Catapult (CGTC) reported that there were 127 ongoing trials in advanced therapy medicinal products (ATMP) in the UK. This represented 12 percent of trials globally, helping to position the UK as a hub in the development of advanced therapeutics. As with any treatment, approval of cell- and gene-based therapeutics relies on robust clinical studies. Here Shrinidh Joshi, freelance biotech consultant at Kolabtree, gives his tips for conducting trials.

In February 2021, researchers at the University of California San Diego launched a phase I trial of gene therapy for treating early Alzheimer’s disease and mild cognitive impairment. The team had previously carried out another phase I study that involved injecting nerve growth factor (NGF) into the brains of eight patients with mild Alzheimer’s and assessing whether the treatment had triggered cognitive improvement. The latest trial will explore the effects of using a different protein than the first study.

Research into autologous therapeutics has intensified and these methods are being used to treat various diseases.

A few years ago, I was working on one trial where we took mesenchymal stem cells (MSC) from patients with Osteoarthritis, modified them so they can perform better, and observed a year later to see if symptoms had improved.

There have also been developments in oncological studies.

In a separate trial, we tried to modify the chimeric antigen receptors (CAR) in natural killer (NK) cells so that they could destroy cancer cells that had become invisible.

Research into the stem and stromal cell treatment continues to grow and these methods offer hope to patients with diabetes, cardiovascular problems, and other unmet illnesses. They can also treat osteoporosis by restoring stem cell functionality, enabling the cells to proliferate and differentiate into bone-forming cells. Like any biological treatment, clinical trials must be conducted on autologous therapies to establish their safety and effectiveness.

STAYING FOCUSSED Generally, biotech companies design trials around four phases. Phase I assesses the safety of a new treatment by testing it on small groups. Phase II uses a larger population made up of different demographics and tests effectiveness by introducing a placebo group. Then, phase III trials monitor the treatment’s impact on an even larger population. At this point, companies can apply for regulatory approval. Finally, phase IV post-market analyses establish the long-term effects, documenting any reported side effects.

While the phased approach is rigorous, it is difficult to control for every variable. All cell and gene therapy treatments are unique and have their own challenges.

Common trial issues include defining the research question, achieving sample randomisation, and selecting control groups and target populations. These can all distract from the core research objectives.

When devising individual phases, biotech firms must establish clear, attainable targets. They can do this is by selecting primary endpoints that determine what is being measured, like the occurrence of a particular symptom.

These can be established by combining several measurable outcomes into a single composite endpoint or by using surrogate markers that may not have a relationship with the real clinical endpoint.

Biotech companies can also maintain research focus by recruiting external specialists that can assist with trial design and regulatory compliance.

SEEKING ADVICE When developing autologous therapeutics, one of the most important skills is knowing when to seek advice. Generally, biotech companies have two options — manufacture in-house or outsource. There are four main steps when developing a gene therapy: raw material preparation, upstreaming, downstreaming, and finally product completion. A company may design the treatment in-house but then approach an external consultant for assistance with combining the vector genome, AAV protein, and helper proteins into a capsid that houses the functioning gene, for instance.

If biotech companies don’t have the in-house skills required for a particular task, they can recruit freelance biotech consultants or specialist biologic contract manufacturing organisations (CMOs). Alternatively, they can collaborate with catapults like the Cell and Gene Therapy Catapult in London or the Centre for Commercialisation of New Medicines (CCRM) in Australia and Canada. Catapults offer technical facilities, expertise, and access to industry, Government, and bodies like the National Health Service (NHS).

Chemistry, manufacturing, and control (CMC) processes are essential during clinical trials and these may differ depending on whether the biotech company is compiling an investigational new drug (IND) application to the US Food and Drug Administration (FDA) or is applying to the European Medicines Agency (EMA).

Regulatory compliance is two-prong — quality assurance and quality control are both keys. Quality assurance requires supplying documentation, checklists, and certificates of verification to ensure there are no issues with the final treatment. On the other hand, quality control flags any defects with existing therapeutics. A freelance biotech consultant can help companies improve their CNC and compliance processes by conducting statistical reviews, writing clinical evaluation reports (CER) and coordinating feasibility studies.

With the UK representing at least 12 percent of the world’s ATMP trials, its biotech industry is heavily focused on researching the effects of gene and cell therapy treatments.

When conducting trials, biotech firms should maintain the same objectives and endpoints throughout. They can also recruit external consultants, including freelancers, CMOs, and catapults, to assist with various tasks.

Need help conducting your cell or gene therapy trial?

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| news |

| BIOSCIENCE TODAY |

Results of MDMA treatment trial for alcohol use disorder published Awakn Life Sciences Inc. announces today the publication of results from its CMO Dr. Ben Sessa’s Bristol Imperial MDMA in Alcoholism (BIMA) trial, an open-label safety, tolerability and proof-ofconcept study investigating the potential role for MDMA therapy in treating patients with alcohol use disorder (AUD).

Results published in the Journal of Psychopharmacology, show that MDMA treatment (3,4-methylenedioxymethamphetamine) was well tolerated by all participants. No unexpected adverse events were observed, and psychosocial functioning improved across the cohort.

the leading cause of death in men aged between 16 and 54 years, accounting for over 20% of the total UK adult population[ii]. These figures are also predicted to rise as a result of the Covid pandemic. While there are current treatment methods available, which are effective for some segments of the population, relapse rates are high.

Over an eight-week course of recovery-based therapy, participants received two sessions with MDMA (187.5 mg each session). Psychological support was provided before, during and after each session. Significantly, at nine months post detox, the average units of alcohol consumption by participants was 18.7 units per week compared to 130.6 units per week before the detox. This compares favourably to a previous observational study (the ‘Outcomes’ study) by the same team with a similar population of people with AUD.

The study team was chaired by Awakn’s chief scientific advisor Prof. David Nutt, Dept of Medicine, Imperial College London. He added, “This clinical study supports the practical experience of many thought leaders in psychiatry that psychedelic-assisted treatments, including MDMA for mental health disorders, have the potential to deliver significantly better outcomes for many patient groups.”

Dr Ben Sessa, Awakn’s Chief Medical Officer, commented, “This is the first clinical study into the potential effectiveness of MDMA-Assisted Psychotherapy as a treatment for Alcohol Use Disorder. It provides preliminary support for the safety and tolerability of MDMA post-detox.

Awakn is now designing further trials to examine better the therapeutic potential of MDMA. I am very grateful for the inspirational work of my research colleagues, Dr. Laurie Higbed, Prof. David Nutt, and Steven O’Brien.”

Alcohol use disorder is the most prevalent substance use disorder, with alcohol use as one of the top five causes of disease and disability in almost all countries throughout Europe[i]. In the UK, alcohol and related diseases are

Awakn is now preparing to bring this research forwards into a Phase IIb study which will take place in the United Kingdom and will be a double-blind, placebo-controlled clinical trial designed to investigate further, the safety and efficacy of MDMA for Alcohol Use Disorder.

Awakn’s CEO Anthony Tennyson said, “Today’s publication of our CMO’s Bristol-Imperial-MDMA-for-Alcoholism (BIMA) study is an important milestone. This was the world’s first clinical research study exploring MDMAassisted psychotherapy as a treatment for any addiction, and the results are promising.. We look forward to advancing this research into Phase IIb in 2021 with our ultimate goal being MDMA-Assisted Psychotherapy approved as a treatment for AUD.” Full study is available at: https://journals.sagepub.com/ doi/full/10.1177/0269881121991792

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95.96

2 8 18 22 8 2

238.02891

Fe

54.938045

Manganese

Molybdenum

Neodymium 92

26

2 8 14 2

6

TM

sputtering targets tungsten carbide

2 8 18 12 1

Dubnium

60

Mn

2 8 13 2

rare earth metals

mesoporous silica MBE

51.9961

180.9488

Praseodymium 2 8 18 32 18 10 2

Cr

25

Chromium

Tantalum

Rutherfordium

Cerium 90

quantum dots

Ce

Ta

24

2 8 13 1

ultralight aerospace alloys

92.90638

178.48

2 8 18 32 18 9 2

2 8 11 2

Niobium

epitaxial crystal growth drug discovery

Nb

Hafnium

Actinium

58

V

50.9415

Vanadium

Zirconium

Lanthanum 2 8 18 32 18 8 2

23

47.867

Yttrium

Barium 2 8 18 32 18 8 1

Y

2 8 10 2

Titanium

88.90585

137.327

Cesium

Fr

2 8 18 8 2

87.62

132.9054

87

Ti

Scandium

Strontium 2 8 18 18 8 1

Sc

22

44.955912

Calcium

Rubidium 55

21

2 8 9 2

isotopes

39.0983

Potassium

3D graphene foam

nanodispersions

Al

He Helium

2 3

Boron

13

2 8 2

2 8 8 2

B

2

4.002602

10.811

Beryllium

nanogels

2

metal carbenes

bioactive compounds

9.012182

Lithium

Na

Be

5

2 2

gold nanoparticles

III-IV semiconductors

screening chemicals

1

buckyballs

janus particles

glassy carbon alternative energy

diamond micropowder

Now Invent!

metallocenes BINAP

conjugated nanostructure

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