Developments continue apace across the UK health and life sciences, with the launch of Genome UK—our national genomic healthcare strategy and the National Quantum Computing Centre, a new atlas of human heart cells, the sequenced genome of Alexander Fleming’s original Penicillium strain, and much more on the research, business, drug, device, diagnostic, healthtech and regulatory fronts.

About 40% of the news items in this issue of BELS Brief Clips involve COVID-19, including progress on vaccines, therapeutics, research, and diagnostics. And as the country struggles to deal with the surging cases of COVID-19, planning is underway to begin challenge trials to speed the approval of vaccines, and long-awaited progress seems to be at hand on the test and trace front, key to keeping businesses open and giving people some semblance of normalcy amid the pandemic.

BELS works to strengthen connections with British-educated life scientists working abroad. To this end, we started publishing BELS Brief Clips in the summer of 2016. Feedback indicates that this publication is a trusted, unique, quick-read, one-stop source of news that is uniquely focused solely on developments across the UK health & life sciences sector. Its popularity—with over 50% of the BELS community being regular readers—is heartening.

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BELS Brief Clips – September 2020

Pandemic a Shot at Redemption in Pharma Industry, Glaxo CEO Says  The Covid-19 pandemic is a chance for the pharmaceutical industry to overhaul its reputation and better explain the drive for profits, GlaxoSmithKline’s chief executive officer said. “The world has never seen our industry as more important,” Walmsley said. “We have a chance to improve our reputation if we deliver on our purpose to find solutions responsibly. But we also need to explain better why it’s in everyone’s interests that we continue to do it profitably.  (Bloomberg  September 29, 2020)

Simple urine test can track what we eat, drink and smoke  Scientists at Aberystwyth University, Newcastle University and Imperial College London have developed a revolutionary urine test that can accurately detect more than 50 different types of food in a person’s diet. It can also detect consumption levels of alcohol and nicotine, including vaping. It works by measuring biomarkers in urine which are created by the digestion of individual foods or from the breakdown of nicotine or alcohol in the body.  (Aberystwyth University  September 29, 2020)

12 Things We Know about COVID-19   Using data drawn from the Health Data Research Innovation Gateway, a new report, 12 things we know about COVID-19, brings into sharp focus our current understanding of the coronavirus pandemic. It features a wealth of detailed information – from how the virus affects the elderly and the obese, to what we know about outbreaks in care homes.  (UKRI  September 29, 2020)

Novacyt Signs Deal with UK Government for COVID-19 Testing Kits   French clinical diagnostics company Novacyt has inked a deal with the UK Department of Health and Social Care for instrument platforms and COVID-19 testing kits. The supply contract includes Novacyt’s q16 and q32 Rapid-PCR instrument platforms, as well as its existing COVID-19 Direct kits and genesig SARS-CoV-2 Winterplex kits.  (PharmaTimes  September 29, 2020)

Smith & Nephew to Pick up Integra’s Orthopedics Business for $240M   Smith & Nephew (Watford) has signed up to acquire Integra LifeSciences’ orthopedics business focused on the growing upper and lower extremity markets. The $240 million cash deal would not only add product portfolios covering shoulder replacements as well as reconstructions of the hand, wrist, elbow, ankle and foot, it would also bring in a dedicated sales force and distributors spanning the US, Canada and Europe.  (Fierce Medtech  September 29, 2020)

Orchard Therapeutics’ Gene Therapy Nabs Accelerated Review in Europe for Neurometabolic Disease   The European Medicines Agency has granted Priority Medicines (PRIME) designation to Orchard Therapeutics’ (London) OTL-203, an ex vivo autologous hematopoietic stem cell gene therapy in development for the treatment of mucopolysaccharidosis type I, a rare neurometabolic disease caused by a deficiency of the alpha-L-iduronidase lysosomal enzyme required to break down sugar molecules. Recently, OTL-203 received US Orphan Drug designation for the indication.  (Seeking Alpha  September 28, 2020)

IONTAS and FairJourney Biologics discover SARS-COV-2 neutralizing antibodies  IONTAS (Cambridge UK) and FairJourney Biologics, two antibody discovery CROs that joined forces this year, announced the discovery of potent SARS-CoV2 neutralising antibodies as potential therapeutics for COVID-19. The newly-identified panel of antibodies have been verified by the National Institute for Biological Standards and Control to block infection at doses as low as 20pM in pseudoviral assays and 100pM in live coronavirus assays, surpassing or matching the best antibodies reported.  (Press release  September 28, 2020)

ValiRx Says Results Show Prostate Cancer Treatment Has Potential  ValiRx (Nuneaton) said its VAL201, a treatment of advanced prostate cancer, saw a 55% response rate in clinical trials involving 11 patients at University College Hospital in London. Six of the 11 patients were "categorised as responding" throughout treatment. This means that the six patients showed no disease progression after treatment with VAL201 was stopped.  (Morningstar  September 28, 2020)

First and only recombinant von Willebrand factor treatment for adults with von Willebrand Disease recommended for routine commissioning via NHS England  Following a review meeting in July 2020, the NHS England Clinical Priorities Advisory Group has provided a positive recommendation for the routine commissioning of Takeda’s VEYVONDI, the first and only recombinant von Willebrand treatment for adults with von Willebrand disease, the most common inherited bleeding disorder. (Press release  September 25, 2020)

Angle Files De Novo FDA Submission for CTC Collection Device in Breast Cancer   Liquid biopsy developer Angle (Guildford) has submitted a full de novo submission to the FDA for its Parsortix system for use with metastatic breast cancer patients. Angle said the submission provides a data package that highlights Parsortix's ability to harvest circulating tumor cells from patient blood samples for downstream analysis. (GenomeWeb September 28, 2020)

First UK patient given GSK’s experimental arthritis drug in COVID-19 trial  A patient in Manchester is the first in the UK to be treated in a new COVID-19 trial investigating the use of an experimental arthritis drug, otilimab, for severe lung disease related to the novel coronavirus. The OSCAR study is being sponsored and funded by GlaxoSmithKline and has been given urgent public health research status by the Department of Health and Social Care. The first dosed patient is receiving care at Manchester Royal Infirmary, although the study is planned to take place at hospitals across the UK.  (PharmaTimes  September 28, 2020)

GSK’s Nucala receives FDA approval to treat HES  The FDA approved GlaxoSmithKline’s Nucala (mepolizumab) as a treatment for hypereosinophilic syndrome (HES) for adult and paediatric patients aged 12 years and above with HES for six months or more without a detectable non-haematologic secondary cause. GSK said the FDA approval marks Nucala as the first and only targeted biologic therapy approved for HES patients in the US. Nucala is a monoclonal antibody designed to prevent IL-5 from attaching to its receptor present on the eosinophils surface, decreasing blood eosinophils to normal levels.  (Pharmaceutical-Technology  September 28, 2020)

Genome UK: the future of healthcare  The Genome UK report sets out a national genomic healthcare strategy to cement the UK’s status as a global leader in genomics by enabling the provision of world-leading genomic healthcare to patients in the UK and across the world. The report sets out how the genomics community will work together to harness the latest advances in genetic and genomic science, research, and technology for the benefit of patients. (HMG September 26, 2020)

UK Market Flooded with Inadequate Covid Tests, Experts Suggest   Inadequate tests for Covid-19, based on poor or dodgy data, are proliferating in the UK because there are no clear rules on what companies have to prove before they can sell them, experts believe. The Royal Statistical Society has set up a working group to investigate and draw up guidelines for the companies making the tests and those who assess them and buy them. (The Guardian  September 27, 2020)

UK to Work with G7 to Promote 5 Point Plan against Another Pandemic: Johnson  Addressing the UN General Assembly, Prime Minister Boris Johnson said that the UK will use its G7 presidency next year to create a new global approach to health security based on a five-point plan to protect humanity against another pandemic. The goals will be to stop a new disease before it starts; develop the manufacturing capacity for treatments and vaccines; design a global pandemic early warning system; have ready protocols for a genuinely global emergency response; and lift export controls wherever possible and agree not to revive them, and cancel any tariffs on the vital tools of our struggle.  (BusinessWorld  September 26, 2020)

New Atlas of the Human Heart Could Guide Personalized Medicine in Cardiology   It takes a vast network of at least 500,000 cells in six regions of the heart to keep the human body up and running. Now, there’s a new atlas of those cells, which cardiology researchers will be able to use to build their understanding of how a healthy heart operates—and what goes wrong when heart disease develops. A multi-institutional team that included Wellcome Sanger Institute (Cambridge UK), Harvard University and Imperial College London analyzed heart cells in order to build an atlas that describes how those cells communicate and coordinate with each other to keep the heart beating. The researchers started by isolating cells from six regions of 14 donated hearts, half from men and half from women. They used single-cell analysis, imaging and artificial intelligence technology to track how genes are switched on and off in each cell.  (FierceMedtech  September 25, 2020)

Poor bone quality is linked to poor heart health  New research by Queen Mary University of London and the University of Southampton’s Medical Research Council Lifecourse Epidemiology Unit has found associations between lower bone mineral density and worse cardiovascular health in both men and women. The study used the internationally unique UK Biobank cohort to investigate links between bone and cardiovascular health. They used a combination of imaging and blood biomarker data to investigate the relationship in the largest sample of people reported to date.  (Queen Mary University London  September 25, 2020)

Novavax starts Phase III Covid-19 vaccine trial in UK  Novavax, which also published Phase I data from its Phase I/II study in early September,  started the Phase III study of its vaccine candidate, NVX-CoV2373, under a partnership with the UK goverment’s vaccine task force. The study is expected to enroll up to 10,000 volunteers aged 18-84.  (MedCity News  September 25, 2020)

UK launches COVID-19 exposure notification app for England and Wales  The last two regions of the UK now have an official coronavirus contacts-tracing app, after the UK government pushed the button to launch the NHS COVID-19 app across England and Wales. Northern Ireland and Scotland launched their own official apps to automate coronavirus exposure notifications earlier this year. But the England and Wales app was delayed after a false start back in May. The key point is that the version that’s launched now has a completely different app architecture. All three of the UK’s official coronavirus contacts-tracing apps make use of smartphones’ Bluetooth radios to generate alerts of potential exposure to COVID-19 — based on estimating the proximity of the devices.  (TechCrunch  September 24, 2020)

Genome of Alexander Fleming’s original penicillin-producing mould sequenced  Alexander Fleming famously discovered the first antibiotic, penicillin, in 1928 while working at St Mary’s Hospital Medical School, which is now part of Imperial College London. The antibiotic was produced by a mould in the genus Penicillium that accidentally started growing in a Petri dish. Now, researchers from Imperial College London, CABI / Center for Agriculture and Bioscience International (Wallingford) and the University of Oxford have sequenced the genome of Fleming’s original Penicillium strain using samples that were frozen alive more than 50 years ago. The team also used the new genome to compare Fleming’s mould with two strains of Penicillium from the US that are used to produce the antibiotic on an industrial scale. The results, published in Scientific Reports, reveal that the UK and US strains use slightly different methods to produce penicillin, potentially suggesting new routes for industrial production.  (Imperial College London  September 24, 2020)

Can a Genetically Modified Bug Combat a Global Farm Plague?  A British biotech firm that developed a genetically modified mosquito to fight dengue fever and other blood-borne diseases in Florida and Texas now has introduced a self-destructing GM caterpillar. Their aim is to stop a pest that is devastating corn and rice crops across the globe. Executives from the US-owned, but UK-based, Oxitec (Oxforde) and its multinational partner Bayer have developed a fall armyworm that has a self-limiting gene introduced into the male of the species. Once the male mates with a female, the resulting egg becomes overloaded with a key protein and quickly dies. The company’s goal is to reduce the population of this kind of worm without pesticides. Small field trials have begun in Brazil.  (Wired  September 24, 2020)

Could a COVID-19 Breath Test Help UK out of Lockdown?   A potential COVID-19 breath test has been unveiled in the UK, as the country desperately searches for alternatives to crippling lockdown measures to prevent the disease from spreading. The breath test has been developed by Integumen (York) in collaboration with Modern Water (London), Avacta (Cambridge) and Aptamer Group (York), which had been working on a test that identifies the SARS-CoV-2 coronavirus in waste water. Based on that technology the companies have designed, built and tested a prototype, Microtox BT, which can analyse the breath and detect the spike protein of the coronavirus in real time. Microtox BT will now be tested at a containment laboratory at the University of Aberdeen (Scotland), followed by a joint trial of up to 5,000 participants, where results will be compared with standard lab antigen tests. Results are expected by the end of the year. If the trial goes well the company said Microtox BT could enable instant real-time testing of people within the community.  (Pharmaphorum  September 24, 2020)

Antibiotic Resistance Spread in Europe Informed by Bacterial Plasmid Sequencing  A team from the UK, Germany, and Italy has demonstrated the value of interrogating sequence data from bacterial plasmids, along with chromosomal sequences, to identify antibiotic resistance genes and track their spread. In a statement, co-senior and co-corresponding author David Aanensen, a genomic pathogen surveillance researcher affiliated with the Wellcome Genome Campus (Cambridge) and Oxford University's Li Ka Shing Centre for Evolution, called plasmids "the missing parts of the puzzle" for following some forms of antibiotic-resistant bacteria.  (GenomeWeb  September 24, 2020)

UK to host 'human challenge' trials for COVID-19 vaccines – FT  Britain is planning to host clinical trials where volunteers are deliberately infected with the new coronavirus to test the effectiveness of vaccine candidates, the Financial Times reported, citing people involved in the project. So-called "challenge trials" are expected to begin in January at a quarantine facility in London, the report said, adding that about 2,000 participants had signed up through a US-based advocacy group, 1Day Sooner. The FT report did not name the vaccines that would be assessed in the project.   (Reuters. September 23, 2020)

New discovery in Coronavirus structure 'could stop virus in its tracks'  An international team of scientists led by the University of Bristol has found a druggable pocket in the SARS-CoV-2 Spike protein that could be used to stop it from infecting human cells. Enabled by using the ARCHER supercomputer, the researchers used a powerful imaging technique, electron cryo-microscopy, to analyse SARS-CoV-2 Spike at near atomic resolution. Their work, a potential game changer in defeating the pandemic, could lead to small molecule anti-viral drugs being developed to target the pocket they discovered, which could help eliminate COVID-19 and stop the virus in its tracks. (UKRI  September 23, 2020)

Liverpool University chooses Better way to teach e-prescribing  Liverpool John Moores University has teamed up with Better.care to teach nursing and pharmacy students about digital prescribing practices. The university is set to use Better’s OPENeP electronic prescribing and medicines administration solution as part of student’s learning. It’s aimed at enabling students to learn about the principles of prescribing, dispensing and administering medicines electronically, as well as exploring the patient safety aspects of the technology.  (DigitalHealth  September 28, 2020)

Genetics Research licenses tech to Oxford Nanopore  Genetics Research has licensed certain of its patents related to its proprietary CRISPR-associated technologies for targeted DNA enrichment to Oxford Nanopore Technologies (Oxford), enabling Oxford Nanopore to enhance its DNA/RNA sequencing platform. The new approach to targeting long DNA fragments for sequence-specific enrichment will allow users of Oxford Nanopore technology to focus on specific genomic regions that are of interest in a multiplex manner. This will allow Oxford Nanopore to bring rapid, near-sample targeted sequencing to market.  (The Science Board  September 22, 2020)

Medicxi’s David Grainger and Francesco De Rubertis pump €200M into Six Companies and What They Say is a First-of-its-Kind Fund  In what they’re billing as a first for biotech, David Grainger, Francesco De Rubertis and their team at Medicxi (London) have put down €200 million to sweep up stakes in six companies from their predecessor VC and pump new money into them. Medicxi didn’t disclose which companies it was investing in but the portfolio draws from Index Ventures Life VI, one of the last funds the Medicxi team launched while they were still part of the multinational, tech-focused VC firm Index Ventures. That team kept advising Index on their life sciences portfolio even after they spun out to form their own firm in the middle of 2016.  (Endpoints  September 22, 2020)

Samsung Biologics and AstraZeneca forge strategic manufacturing partnership for global supply  Samsung Biologics and AstraZeneca announced a long-term supply agreement valued at approximately $330.8 million. Samsung Biologics will provide large-scale commercial manufacturing for drug substance in its Plant 3 as well as drug product to support AZ's biologics therapeutics, which could be increased to $545.6 million. The new partnership will enable AZ to expand its biologics manufacturing capabilities into Asia Pacific and accelerate Korean bio-health innovation. (Biospace  September 22, 2020)

New fast method to enhance endoscopy and minimally invasive surgery developed by researchers  Researchers at King's College London have developed a simple and high-speed method to produce images through a multimode optical fibre with a core diameter just a couple of times larger than that of a human hair. The method, which uses a digital micromirror device with more than one million tiny mirrors, could potentially be used for ultra-thin endoscopy during surgery and in telecommunications. (Kings College London  September 21, 2020)

University of Edinburgh Spinout Cellinta Will Develop Gene Therapies for Cancer   A biotech company spun out of the University of Edinburgh will utilise research to develop new gene therapies to target different types of cancer.  The company, Cellinta Limited (Reading), was born out of research from scientists at the University of Edinburgh, and received funding through investments from SV Health Investors (London) and Cancer Research UK.  The funding will be used to develop a pipeline of ‘highly selective’ gene therapies targeting cancer stem cells in a variety of solid tumour types.  It will draw on research led by Professor Steven Pollard at the University of Edinburgh, which delved into stem cell biology, synthetic biology and cancer genomics.    (PharmaTimes  September 21, 2020)

ESMO: Autolus Provides Glimpse of Next-Generation CAR-T Program, Showing Early Positive Safety Data  CAR-T therapies were hailed as a breakthrough when Novartis received the first FDA approval for Kymriah back in 2017. Though highly effective at treating certain types of blood cancers, CAR-Ts are also associated with severe and potentially deadly side effects, including lethal instances of cytokine release syndrome. With this in mind, Autolus Therapeutics (London) is looking to take a crack at a safer CAR-T and presented Phase II cohort data for its AUTO3 program at virtual ESMO 2020. The data showed that, among the 35 patients in the cohort being treated for r/r diffuse large B cell lymphoma, there were no instances of Grade 3 or higher CRS. Eight individuals saw Grade 1 inflammation while another four patients reached Grade 2. The readout also noted low rates of neurotoxicity.  (Endpoints  September 18, 2020)

Yourgene Inks US Distribution Deal for Chemotoxicity Assay, Other Tests  Molecular diagnostics firm Yourgene Health (Manchester) has signed on Immuno-Biological Laboratories (IBL-America) as a nonexclusive US distributor of its Elucigene DPYD chemotoxicity assay and certain other reproductive health tests. Under the terms of the deal, IBL-America will distribute in the US Elucigene DPYD, which identifies cancer patients with an enzyme deficiency that can result in serious side effects from 5-fluorouracil treatment, as well as Yourgene's PCR-based tests for cystic fibrosis, male factor infertility, and invasive aneuploidy. The tests will initially be sold by IBL-America for research use only to research groups and CLIA labs for in-house validation prior to clinical use. Yourgene may pursue FDA registration of the tests depending on customer demand.  (GenomeWeb  September 21, 2020)

EU Regulators Back Uses for AZ’s Lynparza in Prostate and Ovarian Cancer   AstraZeneca may have had a rough ride following a safety scare with its COVID-19 vaccine, but the company’s busy pipeline is producing successes in other areas. European regulators have recommended that its Lynparza (olaparib) should get additional uses in prostate and ovarian cancer, opening up further avenues for the PARP inhibitor developed in partnership with US-based Merck & Co. The European Medicines Agency’s CHMP scientific committee recommended marketing authorisations in the EU for metastatic castration-resistant prostate cancer with BRCA1/2 mutations. The committee also recommended Lynparza should get its label extended to cover first-line maintenance treatment of ovarian cancer in combination with Roche’s Avastin (bevacizumab), in patients with homologous recombination deficient-positive disease.  (Pharmaphorum  September 21, 2020)

NICE Relents and Okays Akcea’s Rare Disease Drug Waylivra for NHS Use   Patients with the rare disease familial chylomicronemia syndrome will be able to access treatment with Akcea’s Waylivra via the NHS, after a U-turn by NICE. The UK’s cost-effectiveness watchdog rejected NHS England funding of Waylivra (volanesorsen) in January, saying it was too costly and there as a lack of evidence on the long-term benefits of treatment. A single-use syringe of Waylivra costs £11,394 at list prices, but NICE has now given a green light to the medicine after a confidential price cut. A group of rare genetic disorders, FCS affects between 55 and 110 people in England and causes very high levels of triglyceride fat in the blood.  (Pharmaphorum  September 21, 2020)

90-Minute British DnaNudge COVID-19 Test is Accurate, Lancet Study Finds   A British COVID-19 test known as DNANudge that gives results in just over an hour and which requires no laboratory was accurate in almost all cases, an academic review in the Lancet has found. Faster testing could allow more people to return to work or permit testing on entry to hospital, thus slowing a second spike in coronavirus infections. The new test, based on the design of a DNA test developed by a professor at Imperial College London, received approval for clinical use by the MHRA at the end of April after successful trials. In a study in The Lancet Microbe, the test was found to have an average sensitivity (the ability to correctly identify those with COVID-19) of 94.4% and a specificity (correctly identifying those without the disease) of 100%.  (Reuters  September 18, 2020)

Sanofi, GSK sign deal to supply 300 million doses of Covid-19 vaccine in EU states  GlaxoSmithKline and Sanofi have entered into an advanced purchase agreement with the European Commission to supply up to 300 million doses of adjuvanted Covid-19 vaccine. The deal will enable to purchase a Covid-19 vaccine for all member states of the European Union (EU). The reserved doses will be supplied to lower and middle-income countries.  (Pharmaceutical Business Review  September 21, 2020)

Oxford Biomedica Inks R&D Pact with Papyrus Therapeutics for Gene Therapy for Cancer   Privately-held Papyrus Therapeutics and Oxford Biomedica (Oxford) have signed a research collaboration, on the development of a CAR-T product candidate incorporating Papyrus' PYTX-002, a gene replacement therapy for solid tumors. The collaboration will assess the impact and therapeutic benefit of Papyrus’ PYTX-002 that will confer ‘cellular pharmacy’ properties on a CAR-T cell therapy developed by Oxford Biomedica, initially in preclinical in vivo models of solid tumors. Oxford's lentiviral platform technology was used in the first FDA and EMA approved CAR-T cell therapy - Kymriah (tisagenlecleucel). The Group’s lead CAR-T immunotherapy candidate, OXB-302, is a lentiviral CAR-T product targeting the 5T4 antigen expressed on the cell surface of many solid cancers.  (Seeking Alpha  September 17, 2020)

AstraZeneca acquires Dogma’s oral PCSK9 inhibitor programme  AstraZeneca has acquired a preclinical oral PCSK9 inhibitor programme from Dogma Therapeutics for an undisclosed price. AZ plans to advance the PCSK9 inhibitor programme into clinical development for dyslipidaemia and familial hypercholesterolemia in 2021. Dyslipidaemia is a condition in which there is abnormal amount of lipids like low-density lipoprotein (LDL cholesterol) or bad cholesterol present in the blood. On the other hand, familial hypercholesterolemia is a common genetic condition that leads to high cholesterol.  (Pharmaceutical Business Review  September 18, 2020)

Inhaled vaccines in landmark coronavirus trial  Researchers at Imperial College London are set to begin trials to assess the safety and effectiveness of two UK coronavirus vaccines in development. The team will compare vaccine candidates being developed by both Imperial College London and the University of Oxford, delivering the vaccines directly to the respiratory tract of human volunteers by inhalation through the mouth. The hope is that directly targeting the cells lining the airways (the typical point of infection for respiratory viruses) may induce a more effective immune response. This could potentially accelerate the development of effective vaccines against COVID-19 by exploring additional delivery methods and targets.  (UKRI  September 15, 2020)

Birmingham scientists discover the earliest steps in the development of an immune response  The process of white blood cells responding to infections begins earlier than previously thought, according to a new study by scientists at the University of Birmingham. When the body is infected, the white blood cells that make up the immune system step into action to fight back. However, the process of developing immunity is a long, complicated process and it typically takes at least 1 to 2 weeks for the body to eliminate an infection. Crucially, this is often accompanied by the generation of memory immune cells that ‘remember’ this initial infection and ensure that the body is protected in the future. This latest study has revealed that the signal which kick-starts the process actually comes from IL-2 when T cells are activated for the first time, long before they make any decisions about what type of T cell they will turn into. IL-2 promotes the binding of regulatory proteins to genes, to open them up and make them receptive to whatever signal they might see next. When cells then see the master regulators, this next wave of proteins simply bind to sites on genes that were already open.  (University of Birmingham  September 15, 2020)

The Life Scientific - Professor Sarah Gilbert, whose team are developing a COVID-19 vaccine at the University of Oxford, is profiled on BBC Radio 4 in which she describes the team's work. How did Sarah and her Oxford team get so far, so fast in developing a vaccine for Covid-19? (BBC Radio 4  September 15, 2020)

RECOVERY COVID-19 phase 3 trial to evaluate Regeneron’s REGN-COV2 investigational antibody cocktail in the UK  RECOVERY—Randomised Evaluation of COVid-19 thERapY (Oxford), one of the world’s largest randomised clinical trials of potential COVID-19 treatments, will evaluate Regeneron’s investigational anti-viral antibody cocktail, REGN-COV2. The Phase 3 open-label trial in patients hospitalised with COVID-19 will compare the effects of adding REGN-COV2 to the usual standard-of-care versus standard-of-care on its own, evaluating the impact of REGN-COV2 on mortality, hospital stays, and the need for ventilation.  (RECOVERY Trial  September 14, 2020)

STFC laser helps reveal properties of superbug killer  Scientists have used high resolution microscopy techniques at Science and Technology Facilities Council’s Octopus imaging cluster to investigate the properties of a compound which kills antibiotic-resistant superbugs. The research team, led by the University of Sheffield, developed a new compound that has killed antibiotic-resistant bacteria, such as MRSA and E.Coli, during tests. The compound has been able to kill both gram-negative and gram-positive bacteria.  (UKRI  September 14, 2020)

Lab-grown bone could change the way we test new medical treatments  University of Sheffield engineers have developed a technology that could change the way we test new medical treatments to repair human organs and bone tissue. The new technology uses mini scaffolding - three dimensional structures capable of growing human tissue in a lab. The process uses a new bone-on-a-chip system that could revolutionise pharmaceutical pre-clinical testing. The development could reduce the number of animal models used in research.  (University of Sheffield  September 14, 2020)

The future of genomic medicine: can it fulfil its promises  Last week geneticist Dr Charles Steward shared his experiences of searching for a genetic cause for his children’s rare neurological diseases. Here he gives us a deeper look at how genomic medicine is evolving and the barriers that are preventing it from reaching its full potential. Through his work at the Wellcome Sanger Institute and Congenica (Cambridge UK), and involvement with the 100,000 Genomes Project, Charlie has been well placed to see the development of genomics over the years and the promises that it will bring to healthcare. However, he says there is always the danger of overpromising the benefits and at the same time, underdelivering.   (Pharmaphorum  September 14, 2020)

Coronavirus: UK to Test Inhaled Vaccines  UK researchers are to begin trials of inhaled coronavirus vaccines.  Delivering doses directly to the lungs might give a better immune response than conventional jabs, they say.  The Imperial College London team will use two frontrunners already in development - the Oxford one recently paused in trials and one from Imperial that entered human testing in June.  There are nearly 180 candidates being explored globally - but none has yet reached the end goal.  About 30 healthy volunteers will be given the vaccines as a mist or aerosol - in the same way asthma drugs are delivered with a nebuliser machine and a mask or mouthpiece.  The seasonal flu jab can also be given as a nasal spray rather than an injection.  (BBC September 14, 2020)

Syncona Expands Cell Therapy Portfolio   Following a collaboration agreement with the University of Edinburgh in 2018, Resolution Therapeutics (London), a cell therapy company investigating the use of macrophages for the treatment of patients with end-stage liver disease, has been founded by Syncona (London) with a £26.8M commitment to a Series A financing.  (Shares Magazine  September 14, 2020)

Trials resume for AZ/Oxford University COVID-19 vaccine  After a voluntary pause across all global trials instituted after a patient in the UK suffered a reported side effect, the MHRA has confirmed that trials can restart in the UK.  (PM Live  September 14, 2020)

UK Signs $1.6B Supply Development Agreement for Valneva's COVID-19 Vaccine Hopeful  The biggest drugmakers in the hunt for a COVID-19 vaccine have been racing to lock up national supply deals for months in anticipation of global demand for a winner. Even the lesser-known contestants are selling their wares around the world, though—and the UK appears to be buying.  The British government has set aside $1.63 billion for a five-year supply of French drugmaker Valneva's inactivated COVID-19 shot. The deal could bring up to 190 million doses to the country by 2025.  The pact includes an initial $558 million order for 60 million doses, set to be shipped by the second half of 2021. The UK then has two follow-up options: An additional 40 million doses for 2022, and between 30 million and 90 million doses to be delivered by 2025.  (FiercePharma  September 14, 2020)

NICE U-turns to approve AstraZeneca's Tagrisso in two new lung cancer indications  NICE has announced the recommendation of AstraZeneca’s Tagrisso (osimertinib) for routine use on the NHS in England and Wales in two new lung cancer indications. The first is in locally advanced or metastatic epidermal growth factor receptor-positive non-small cell lung cancer. The decision was based on clinical data demonstrating the therapy’s benefit in progression-free survival compared to current standard of care of a daily oral dose of NICE-approved afatinib, erlotinib, gefitinib or dacomitinib.  (Pharmafile  September 11, 2020)

New testing device can detect COVID-19 in 15 minutes  A new diagnostic test, developed at the University of Southampton, could provide rapid, inexpensive testing of COVID-19 recent trials have shown. Current testing using the standard PCR test requires samples to be sent to a laboratory which means results are not available until one or two days later. The new test can detect the presence of the SARS-CoV-2 virus which causes COVID-19 in 10 – 15 minutes. The test involves taking a patient’s nasal swab and mixing it with a solution in a tube. Working in a similar way to the commonly available pregnancy test, a paper strip containing a capture antibody is then dipped into the tube to absorb the solution. As the liquid moves up the strip, a red line will appear if the virus is present in the sample.  (University of Southamptom  September 10, 2020)

20 Second Coronavirus Test Piloted at UK's Heathrow Airport  Two British companies are preparing to launch a simple COVID-19 saliva screening test that aims to provide an accurate result within 20 seconds—following its first uses at London’s Heathrow airport, one of the busiest in the world.  The Virolens device, developed by iAbra (Bedfordshire), uses a digital microscope and artificial intelligence-powered software to visually search a mouth swab sample for signs of the novel coronavirus.  The machine provides a low-cost, repeatable and self-administered method of screening, allowing hundreds of cartridge-based tests to be performed each day, according to iAbra’s manufacturing partner TT Electronics (Woking). Validation studies by the University of Bristol have pegged the system’s false-negative rate of 0.2%, alongside a false-positive rate of 3.3%.  The Virolens device underwent its first rounds of field testing among Heathrow employees, and its developers are now planning full clinical trials to gain certifications for medical use.  (Fierce Medtech  September 10, 2020)

SkylineDx, Imperial College London, UCSD Partner to Develop Kawasaki Disease Test  Oncology and inflammatory diseases molecular diagnostics firm SkylineDx has inked a collaboration agreement with researchers at Imperial College London and the University of California San Diego School of Medicine for the joint development of a diagnostic test for the early diagnosis of Kawasaki disease.  (GenomeWeb  September 10, 2020)

AstraZeneca COVID-19 Vaccine on Track for 2020 Filing Despite Delay, Soriot  AstraZeneca is still on track to file for approval of its COVID-19 vaccine this year, according to its CEO. Pascal Soriot told attendees at an online event that it is unclear how long the trial will be paused in response to a recent adverse event, but a 2020 approval is still on the cards.  Earlier in the year, AZ said it was on track to show whether its COVID-19 vaccine worked by September. Hopes of a fall approval had begun to fade long before AZ placed development of the vaccine on hold after a participant in the program suffered an unexpected illness, but Soriot still thinks AZ has a shot at being one of the companies that gets to market this year.  (FierceBiotech  September 10, 2020)

FDA approves Trelegy Ellipta for new asthma indication  The FDA has approved Trelegy Ellipta, once-daily, single-inhaler triple therapy, for the new indication of treatment of asthma in. Trelegy Ellipta (GlaxoSmithKline and Innoviva) is the first single-inhaler triple therapy approved for both asthma and COPD. The triple therapy combines fluticasone furoate, an inhaled corticosteroid; umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist. Trelegy Ellipta was approved by the FDA in 2017 for long-term, once-daily maintenance treatment in patients with COPD.  (Healio  September 9, 2020)

Innovate UK Grants University of Oxford, ATDBio £370K for Single-Cell Sequencing Tech Development  Synthetic oligonucleotide manufacturer ATDBio (Southampton) and researchers from the University of Oxford have won a £369,632 ($480,084) grant from Innovate UK to develop tagged microbeads for use in single-cell RNA sequencing library preparation. ATDBio will develop improved oligonucleotide tagged beads, "which will help enhance the quality of the sequencing results and enable new types of experiments”.  (GenomeWeb  September 9, 2020)

Research collaboration with Jazz Pharmaceuticals  Redx Pharma (Cheshire), which will lead discovery and preclinical development activities on two cancer targets on the Ras/Raf/MAP kinase (MAPK) pathway. Redx will be responsible for research and preclinical development activities up to IND submission and will receive $10 million upfront and $10 million in year 2 with up to a further $400 million in milestone payments, plus tiered royalties. The research collaboration recognises Redx's expertise in oncology drug design following previous sale of Redx's pan-RAF inhibitor programme to Jazz in July 2019.  (London Stock Exchange  September 9, 2020)

Sir John Kingman to step down as UKRI chair in 2021  After a successful five-year period as Chair of UK Research and Innovation, Sir John Kingman has announced he will step down from the role in May 2021. Sir John was appointed in 2016 to realise the vision of the Nurse Review and create a single, ambitious organisation that would deliver a world class UK funding system. He led UKRI through its early formation stages, the passing of the Higher Education and Research Act (the legislation that created UKRI) and its official launch in April 2018. Kingman said, “By Summer 2021, Dame Ottoline Leyser will have completed her first year as UKRI Chief Executive and that creates a natural moment for me to hand over the Chair to a successor who can help take UKRI to the next stage."  (UKRI  September 9, 2020)

DNAnudge, Benchmark Electronics Ink Manufacturing Deal Rapid Molecular  Benchmark Electronics and DNANudge (London) announced a manufacturing partnership aimed at the high-volume production of DNANudge's RT-PCR testing system for SARS-CoV-2.  Financial and other terms of the deal were not disclosed.  DnaNudge has re-engineered its consumer DNA test to detect SARS-CoV-2. The test system delivers results in about an hour and does not require use of a laboratory, the firms said.  The new test, CovidNudge, works by placing a patient's swab sample into a single-use DNA cartridge. RNA extracted from the sample is inserted into a system component called the NudgeBox for analysis and reverse transcribing to DNA.  (GenomeWeb  September 9, 2020)

Covid-19: Government plans to spend £100bn on expanding testing to 10 million a day  Internal correspondence reveals that the government is prepared to almost match what it spends on the NHS in England each year (£130bn) to fund mass testing of the population “to support economic activity and a return to normal life” under its ambitious Operation Moonshot programme. The UK-wide Moonshot programme is expected to “cost over £100bn to deliver.” If achieved, the programme would allow testing of the entire UK population each week.  (BMJ  September 9, 2020)

Verona Pharma launches pilot study of ensifentrine for Covid-19  Verona Pharma (London) has launched a pilot study to assess ensifentrine administered via a pressurised metered-dose inhaler (pMDI) formulation in US patients hospitalised with Covid-19. Ensifentrine is known to exhibit bronchodilator and anti-inflammatory activities. Data from clinical studies in other respiratory diseases demonstrated that the drug improved oxygenation and mucus clearance, as well as reduced inflammation in the lungs. Verona Pharma added that the drug was well tolerated in trials involving more than 1,300 participants to date.  (Clinical Trials Arena  September 8, 2020)

UK government invests £32m in health tech projects  The UK government is to invest £32 million ($41.5 million) in six health technology projects aiming to transform care for debilitating diseases such as cancer and osteoarthritis. Projects include a novel artificial intelligence (AI) X-ray scanner to diagnose cancer and osteoarthritis more effectively and robotic muscles to assist those who have suffered from a stroke. The scheme is part of a commitment to help advance healthcare outcomes through its Research and Development Roadmap and to increase R&D public spending to £22 billion per year by 2024 to 2025.  (PharmaPhorum  September 8, 2020)

Destiny, SporeGen Collaborate on COVID-19 Prevention Spray  UK biotechs Destiny Pharma (Brighton) and SporeGen (Egham) have entered into a collaborative agreement to develop a new preventative treatment for COVID-19, with support from an £800,000 grant from Innovate UK.  Under the agreement, the parties will co-develop SporeGen’s SPOR-COV – a proprietary formulation of Bacillus bacteria that will be administered nasally as a spray – sharing any costs and commercial returns.  The companies said they plan to complete a preclinical programme for SPOR-COV with the aim of being ready to enter the first human clinical trials within 18 months.  The drug has already been shown by SporeGen to provide complete (100%) protection in preclinical models of influenza virus.  SPOR-COV is different to vaccines in that it utilises the innate immune system with the aim of developing COVID-19 protection a few days after dosing.  As an 'easy to use' first line of defence, it has the potential to reduce COVID-19 infection rates and transmission significantly, and also could be stockpiled “almost indefinitely without the need for cold chain refrigeration” as it is very stable.  (Pharma Times  September 7, 2020)

Persistent immune memory of COVID-19 found in recovered patient T cells  Oxford University researchers have found that infection with COVID-19 produces a robust T cell response, including inducing T cell ‘memory’ to potentially fight future infections.  New research published in Nature Immunology shows strong T cell responses in patients recovered from COVID-19. The discovery of epitope clusters eliciting T cell response helps inform an understanding of how patients recover from the disease and to support future developments for patient benefit.  (University of Oxford  September 4, 2020)

Sanofi and GSk Begin Clinical Trials of Coronavirus Vaccine  Sanofi and GlaxoSmithKline have begun clinical trials of their coronavirus vaccine, as AstraZeneca expanded studies of its rival into Japan.  The French pharma Sanofi in April joined forces with the UK’s GlaxoSmithKline to produce the vaccine, with Sanofi contributing an antigen that produces the immune reaction.  Meanwhile GSK is producing the booster that reduces the amount of active ingredient necessary to produce an effect.  They said the trials would involve 440 adults at 11 sites across the US.  If data from the phase 1/2 trial are positive, the companies aim to move into a phase 3 trial by the end of the year.  They are also scaling up manufacturing of the antigen and adjuvant, aiming to produce up to a billion doses in 2021.  If trials go well the companies could request regulatory approval in the first half of 2021.  Sanofi is leading the clinical development and registration of the COVID-19 vaccine.  (Pharmaphorum  September 4, 2020)

Sensyne Health launches ‘SENSE’ in partnership with Microsoft  Sensyne Health (Oxford) has launched its 'SENSE' system in the UK, which was developed in partnership with Microsoft as part of an existing collaboration between the two groups. SENSE was developed in partnership with Microsoft and the UK Clinical AI company’s health cloud technology. The technology platform is a clinical algorithm engine which generates AI algorithms (called SYNEs) for real-time decision support across multiple medical conditions. SYNEs enable clinicians and health systems to input up-to-date information on their patients which is analysed using machine learning against the SENSE database and then used to provide reasoned advice to make clinical decisions and improve operational efficiency. Sensyne said it has now signed its first agreement with Chelsea & Westminster Hospital NHS Foundation Trust for an algorithm produced by the SENSE system called SYNE-COV.  (Vox Markets  September 3, 2020)

Tracing apps may stem COVID-19 spread even when only a few use them: study  Contact tracing apps can sharply reduce the spread of the novel coronavirus even when only a few people use them, a study published by researchers at Google and Oxford University showed. An app used by 15% of the population together with a well-staffed contact-tracing workforce can lead to a 15% drop in infection rates and an 11% drop in COVID-19 deaths, according to statistical modeling by the Alphabet Inc unit and Oxford’s Nuffield Department of Medicine.  (Reuters  September 3, 2020)

Compass plans $100m IPO to fund magic mushroom depression drug  Compass Pathways (London) is planning a $100 million US IPO as it seeks to further develop its depression treatment based on psilocybin – an active ingredient that can be found in magic mushrooms. In a filing with the US financial regulator Compass laid out its plans to develop the drug known as COMP360, which is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression.  (Pharmaphorum  September 3, 2020)

Heritable genome editing not yet ready to be tried safely and effectively in humans  Human embryos whose genomes have been edited should not be used to create a pregnancy until it is established that precise genomic changes can be made reliably without introducing undesired changes — a criterion that has not yet been met by any genome editing technology, says a new report by the International Commission on the Clinical Use of Human Germline Genome Editing, an international group put together by the US National Academies of Medicine and Sciences and the UK’s Royal Society co-chaired by geneticist Kay Davies of the University of Oxford.  (The Royal Society  September 3, 2020)

Building up its AI Operations, GSK Opens a $13 Million London Hub with Plans to Woo Talent Now Trekking to Silicon  Continuing its efforts to ramp up global AI operations, GlaxoSmithKline has opened a £10 million ($13 million-plus) research base in Kings Cross, London. The AI hotspot is already home to Google’s DeepMind, and the Francis Crick and Alan Turing research institutes. GSK said it hopes to “tap into the huge London tech talent pool” and attract candidates who might otherwise head to Silicon Valley.  (Endpoints  September 2, 2020)

Science Minister launches National Quantum Computing Centre  Science Minister Amanda Solloway has launched the UK’s National Quantum Computing Centre, established through a £93 million investment by UKRI. Quantum computers can perform tasks that are practically impossible using conventional computers, and their deployment will tackle previously insurmountable challenges across society and the economy, from rapid-fire drug discovery to ultra-efficient batteries for electric vehicles. This will lead to new jobs, skills and knowledge creation.  (UKRI  September 2, 2020)

MHRA post-transition period information  From 1 January 2021, the UK Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator. Transition from the EU allows the UK to offer fully independent regulatory decisions for both devices and pharmaceuticals, both nationally and in joint work with other international regulators. Information about clinical trials, devices, licensing, IT systems, pharmacovigilance, etc. can be found at the link above. (HMG  September 1, 2020)

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