A recently published study examines the evolutionary and epidemiologic history of an epidemic strain of extensively drug-resistant tuberculosis (XDR-TB) – called LAM4/KZN – in KwaZulu-Natal, South Africa. This strain was first reported in a 2005 outbreak in Tugela Ferry, KwaZulu-Natal, where it was associated with 90 % mortality among predominantly HIV infected individuals, and has since become widespread throughout the province. A new study identifies key host, pathogen and environmental factors that facilitated the success of this XDR-TB strain and steps that can be taken for early identification and containment of future epidemics.
The study, led by Columbia University, involved a multi-institutional team of researchers from South Africa, the United States, and Norway, used genomic, spatial and protein modelling to answer when and where this strain emerged, and how and why it became widespread. The study utilized data and TB strains collected in the prospective XDR-TB transmission study (TRAX) from 2011 to 2014 led by Emory University, the University of KwaZulu-Natal, and the U.S. Centers for Disease Control and Prevention.
Researchers localized the geographic origin of the strain to a rural district, bordering Mozambique and eSwatini, with high pre-existing rates of drug-resistant TB located 400 hundred kilometres away from where the first outbreak of LAM4/KZN was reported. Results also indicate that the strain emerged in the early 1990s, acquiring key advantageous mutations prior to undergoing marked expansion concurrent with the onset of the generalized HIV epidemic. In addition, the study suggests cyclical rural-urban migration in the rapid and widespread dissemination of this strain.
"Our results indicate that this strain of XDR-TB emerged approximately 12 years before it was identified by public health activities," said lead researcher Barun Mathema, PhD, assistant professor of epidemiology at Columbia University Mailman School of Public Health. "Our research highlights multiple environmental and pathogen-specific factors must align in order for these pathogens to establish sustained transmission and disperse into geographically separated populations. These processes take place in the so-called ‘pre-detection’ period, years before the pathogens are first noticed as public health threats," said Mathema.
"From our findings, we learned the importance of HIV coinfection, high pre-existing rates of drug-resistant TB, human migration, and adaptive evolution in the emergence and dispersal of this critical public health threat," noted first author Tyler S. Brown, MD, research fellow in the Infectious Diseases Division at Massachusetts General Hosptial.
"Routine integration of whole-genome sequencing into public health surveillance can address any knowledge gaps and enable us to better understand the pre-detection period and inform strategies for early identification and local containment of AMR pathogens," observed Mathema. "Surveillance, enabled by the rapidly decreasing cost of pathogen sequencing, can provide a powerful strategy for public health practitioners."
https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png003wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:31:372021-01-08 11:07:59Using whole-genome sequencing for early identification and containment of AMR pathogens
Grey Wolf Therapeutics, a drug discovery biotechnology company focused on developing first-in-class therapies for immuno- oncology (IO), has completed a £2.5 million ($3.3 million) Series A2 financing round with existing healthcare investors Andera Partners and Canaan.
The new funding will allow the company to accelerate development of therapies targeting endoplasmic reticulum aminopeptidase 2 (ERAP2), following many positive signals of its potential. Funds will also be used to continue to drive the lead endoplasmic reticulum aminopeptidase 1 (ERAP1) modulator program.
Both of Grey Wolf’s novel ERAP approaches are aimed at directly altering tumour cells, illuminating them for attack and destruction by the immune system. The goal is to exploit this increased tumour visibility in monotherapy and to extend the therapeutic benefit of already approved immunotherapies to many more cancers. The company is developing small molecule modulators of ERAP1 and ERAP2, two key proteins in the antigen presentation pathway, to change the antigen repertoire of tumours and thereby increase the number and range of cancer-related antigens, including neoantigens, presented on tumour cells available to engage an immune response. Grey Wolf is expanding efforts around ERAP2 for two reasons. First, clinical data continues to demonstrate that tumours which are more visible to the immune system show improved responses to checkpoint inhibitors. Second, the company has developed unique insight into the targeting of the ERAP enzymes through the lead program ERAP1 and validated the role for ERAP inhibition in modulating the cancer-related antigen repertoire.
“We have continued to generate data showing that modulation of both ERAP pathways drives change to the cancer-related antigen repertoire,” said Tom McCarthy, Executive Chairman and Co-Founder of Grey Wolf Therapeutics. “Data clearly demonstrates that modulation of ERAP2 drives an altogether different change to the antigen repertoire, when compared with ERAP1 modulation, due to ERAP2’s clearly differentiated peptide substrate specificities. With this investment and the prior knowledge base within Grey Wolf we will be able to accelerate the ERAP2 program quickly through optimization, building on our leading position in ERAP disease-related biology.”
https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png003wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:31:372021-01-08 11:07:59Grey Wolf Therapeutics completes £2.5 million financing to accelerate development of therapies targeting ERAP2
The clinical diagnostics, company Beckman Coulter has implemented DxH 900 haematology analysers and the Early Sepsis Indicator across the South West London Pathology (SWLP) network. SWLP is an award-winning NHS pathology partnership set up by St. George’s University Hospitals NHS Foundation Trust, Croydon Health Services NHS Trust and Kingston Hospital NHS Foundation Trust. The installation enables SWLP laboratories to provide a single, integrated pathology service to more than 3.5 million people across South West London via three hospitals, 200 GP practices and 30 community healthcare sites.
Beckman Coulter’s DxH 900 haematology analysers enable clinical laboratories like SWLP to perform complete blood count and white blood cell differential tests. Demonstrating an industry-leading 93% first-pass yield, the DxH 900 reduces the number of manual slide reviews, helping to generate reportable results as quickly as possible. In addition, the DxH 900 features the Early Sepsis Indicator, the only CE marked and FDA-cleared haematologic biomarker that aids the diagnosis of sepsis in adult patients.
Commenting on the implementation, Simon Brewer, Managing Director at South West London Pathology, said: “Emergency departments across our network see 370,000 patients a year. And, with conditions like sepsis becoming more and more prevalent, it is mission critical to have the tools and technology to identify, diagnose, and begin treatment as early as possible.”
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BioCity, a life science incubator and business collective has released its biennial publication, the UK Life Science Start-Up Report, an in-depth analysis of emerging businesses within the life sciences across the UK.
The report looks at the prevalence of life science start-ups in the UK over the past five years and the broader landscape in which they operate to also asses the quality of UK life science start-ups.
The report documents an unprecedented period of growth for the life sciences, thanks in part to a change in the funding landscape, expressed in a four-fold increase to £2.8 billion of investment in early-stage ventures, compared to the previous five-year period.
Multiple factors are highlighted as driving this expansion, but of greatest impact was Industry news January 2020 11 | the emergence of a number of significant venture funds able and willing to make very large investments in early stage businesses. Also identified as a contributing factor is the increasing use of smaller companies and academia as sources of innovation by large pharma companies aiming to counteract falling R&D productivity. Simultaneously, many universities such as Bristol, Newcastle and Aberdeen introduced a gear change in spin-out formation.
Author of the report, Dr Glenn Crocker said: “Both the number of companies starting up and the amount invested in them has taken off. We have seen a 50% increase in the number of companies and a four-fold increase in investment going into them; this will likely result in a substantial increase in the demand for space. We estimate that this cohort of businesses alone could require 1.4 million sq ft of specialist facilities over the next five years. One consequence of this demand growth is that real estate investors are being increasingly attracted to the sector.”
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Researchers at Karolinska Institutet have developed a method based on artificial intelligence for histopathological diagnosis and grading of prostate cancer. The AI-system has the potential to solve one of the bottlenecks in today’s prostate cancer histopathology by providing more accurate diagnosis and better treatment decisions. The study shows that the AI-system is as good at identifying and grading prostate cancer as world-leading uro-pathologists.
“Our results show that it is possible to train an AI-system to detect and grade prostate cancer on the same level as leading experts,” says Martin Eklund, associate professor at the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet who led the study. “This has the potential to significantly reduce the workload of uro-pathologists and allow them to focus on the most difficult cases.”
A problem in today’s prostate pathology is that there is a certain degree of subjectivity in the assessments of the biopsies. Different pathologists can reach different conclusions even though they are studying the same samples. This leads to a clinical problem where the doctors must pick treatment based on ambiguous information. In this context, the researchers see significant potential to use the AI-technology to increase the reproducibility of the pathological assessments.
To train and test the AI system, the researchers digitized more than 8000 biopsies taken from some 1200 Swedish men in the ages of 50–69 to high-resolution images using digital pathology scanners. About 6,600 of the samples were used to train the AI system to spot the difference between biopsies with or without cancer. The remaining samples, and additional sets of samples collected from other labs, were used to test the AI system. Its results were also compared against the assessments of 23 world-leading uro-pathologists. The study was conducted in collaboration with researchers at Tampere University in Finland.
The findings showed that the AI-system was almost near-perfect in determining whether a sample contained cancer or not, as well as in estimating the length of the cancer tumour in the biopsy. When it comes to determining the severity of the prostate cancer, the so-called Gleason score, the AI system was on par with the international experts.
“When it comes to grading the severity of the prostate cancer, the AI is in the same range as international experts, which is very impressive, and when it comes to diagnostics, to determine whether or not it is cancer, the AI is simply outstanding,” says Lars Egevad, professor in pathology at Karolinska Institutet and co-author of the study.
The initial findings are promising but more validation is needed before the AI system may be rolled out broadly in clinical practice, according to the researchers. That is why a multicenter study spanning nine European countries is currently underway with completion slated by the end of 2020. That study, which is financed by EIT Health, aims to train the AI-system to recognize cancer in biopsies taken from different laboratories, with different types of digital scanners and with very rare growth patterns. In addition, a randomized study starting in 2020 will examine how the AI-model may be implemented in Sweden’s health care system.
“AI-based evaluation of prostate cancer biopsies could revolutionize future health care,” says Henrik Grönberg, professor in cancer epidemiology at Karolinska Institutet and head of the Prostate Cancer Center at St Göran Hospital in Stockholm. “It has the potential to improve the diagnostic quality, and thereby secure a more equitable care at a lower cost.” Karolinska Institute
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Johnson & Johnson has announced the selection of a lead COVID-19 vaccine candidate on which it expects to initiate human clinical studies by September at the latest with the first batches of the vaccine available for emergency use authorization in early 2021.
In addition, the company announced the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA).
Johnson & Johnson also said the company will rapidly scale up its manufacturing capacity with the goal of providing a global supply of more than one billion doses of the vaccine.
Through the new partnership, BARDA and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. The company says will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts.
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services.
Commenting on the initiative, Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson, said: “The world is facing an urgent public health crisis and we are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible. As the world’s largest healthcare company, we feel a deep responsibility to improve the health of people around the world every day. Johnson & Johnson is well positioned through our combination of scientific expertise, operational scale and financial strength to bring our resources in collaboration with others to accelerate the fight against this pandemic.”
The company’s expansion of its manufacturing capacity will include the establishment of new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries. The additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses of a safe and effective vaccine globally.
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said: “We are very pleased to have identified a lead vaccine candidate from the constructs we have been working on since January. We are moving on an accelerated timeline toward Phase 1 human clinical trials at the latest by September 2020 and, supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021.” In addition to the vaccine development efforts, BARDA and Johnson & Johnson have also expanded their partnership to accelerate Janssen’s ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. The company’s aim is to identify potential treatments against the novel coronavirus. Johnson & Johnson and BARDA are both providing funding as part of this partnership. These antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven), in Belgium.
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A research consortium led by the Jenner Institute, Oxford University is set to begin fast-tracked clinical trials for a COVID-19 vaccine.
The adenoviral vaccine candidate, ChAdOx1 nCov-19 (ChAdOx1) is one of five frontrunner vaccines in development around the world, and expected to be the UK’s first COVID-19 vaccine.
Developed at the Jenner Institute, ChAdOx1 is one of the most promising vaccine technologies for COVID-19 as it can generate a strong immune response from one dose.
Cobra Biologics (Cobra), an international CDMO for biologics and pharmaceuticals, issued a statement 31 March saying they had joined the consortium to assist with the rapid development scale-up and production of the vaccine.
The ChAdOx1 consortium includes the University of Oxford Jenner Institute, University of Oxford Clinical Biomanufacturing Facility, the Vaccines Manufacturing and Innovation Centre (VMIC), Advent Srl, Pall Life Sciences, Cobra Biologics and Halix BV.
The consortium is currently recruiting individuals from a range of ages in the UK to trial the vaccine’s efficacy, in April 2020 – a crucial step in the vaccine’s development. Cobra is actively planning for a fast set-up phase to facilitate the efficient production of a GMP working cell bank and then 200L GMP viral vaccine. The consortium partners expect to develop and manufacture the vaccine candidate in multiple batches, to support a 1 million dose scale batch size, by mid 2020.
For more information about the trial, visit: www.covid19vaccinetrial.co.uk
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Siemens Healthineers’s latest critical care testing solution, the RAPIDPoint® 500e Blood Gas Analyzer, has received clearance from the U.S. FDA, and is now available in the U.S., Europe and countries requiring the CE mark. The analyser generates blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin results, which are used to diagnose and monitor critically ill patients in the intensive care unit, operating room, or emergency room.
The RAPIDPoint 500e Blood Gas Analyzer is an essential instrument supporting COVID-19 response efforts, where blood gas testing plays a critical role in managing infected patients and monitoring their respiratory distress. Routine blood gas testing is also performed when patients require mechanical ventilation. Arterial blood gas tests provide the status of a patient’s oxygenation levels and enable healthcare providers to determine whether adjustments to ventilator settings or other treatments are required.
“The RAPIDPoint 500e Blood Gas Analyzer has become a trusted instrument in Europe’s endeavour to combat COVID-19 and to help address an unprecedented demand for blood gas testing in affected respiratory patients,” said Christoph Pedain, Head of Point of Care Diagnostics, Siemens Healthineers.
“Point-of-care teams monitoring respiratory conditions in critical care settings need a blood gas testing solution that delivers fast, accurate results and increases workflow efficiencies. A safe operating environment amid growing concerns about cybersecurity threats in healthcare is also important.”
The analyser elevates confidence in patient results with Integri-sense Technology, a comprehensive series of automated functional checks designed to deliver accurate test results at the point-of-care. Additionally, the RAPIDPoint 500e Analyzer integrates seamlessly into hospital networks with the Siemens Healthineers Point of Care Ecosystem, which offers convenient, remote management of operators and devices located across multiple sites.
Commenting on the device, Dr. Daniel Martin, Royal Free Hospital, London, said: “As an ICU physician, I know that the values I am handed during an emergency allow me to confidently make life-saving decisions. The RAPIDPoint system is easy to use and allows me to not worry about the machine and focus my attention on my patients.”
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UK-based PCR Biosystems issued a statement 1 April saying they are continuing to scale up operations to ensure the critical enzyme mix for COVID-19 tests remain available to the UK and global healthcare systems as demand for testing rises.
To meet current and upcoming requirements and ensure supply chain security, PCR Biosystems has already significantly increased – and will continue to increase – manufacture of qPCRBIO Probe 1-Step Go and all other critical reagents for rapid and sensitive RT-qPCR, the company said.
The company noted it has capacity to manufacture enough reagent daily for 4 million reactions – which is sufficient for millions of diagnostic tests.
qPCRBIO Probe 1-Step Go is a universal probe kit designed for fast and sensitive probe-based RT-qPCR. It is PCR Biosystems’s recommended product for COVID-19 diagnostic tests, supporting the detection, quantification and typing of the SARS-CoV-2 virus. All that’s required is the addition of specific primers and probes, together with the swab extract and water. qPCRBIO Probe 1-Step Go is compatible with all qPCR instruments and is engineered for use on a wide range of probe technologies including TaqMan®, Scorpions® and molecular beacon probes. In March 2020, PCR Biosystems introduced bulk pack sizes of this key product, to further support customers in high-throughput COVID-19 testing.
Alex Wilson, Co-Founder of PCR Biosystems, explained: “These are unprecedented times, and, as a global PCR company, we are ideally placed to support the scientific and healthcare communities in their response to COVID-19. When the enormity of COVID-19 testing requirements became apparent, we immediately started scaling up production of the critical components. We already have capacity to supply 4 million reactions’ worth of reagent every day – and we have the option to scale up further if needed to ensure we can always meet global demand.”
For more information on PCR Biosystems’s reagents, visit: www.pcrbio.com
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OXGENE and The Native Antigen Company are collaborating to scale up production of SARS-CoV-2 reagents by combining OXGENE’s proprietary Adenoviral Protein Machine Technology with The Native Antigen Company’s antigen development expertise. Together, they aim to scale their antigen manufacturing capabilities to deliver high-purity, recombinant proteins for the development of diagnostics and vaccines.
Unlike the PCR tests that are currently being used, these diagnostics will be able to confirm past infections and determine levels of immunity to SARS-CoV-2. This could be invaluable for disease modelling and public health policy, as true transmission rates and case fatality rates can be determined. These tests could also be instrumental for the diagnosis of healthcare workers who have been exposed to the virus to ensure that they have developed natural immunity before returning to work, and to help measure patient immune responses for the rapid development of a SARS-CoV-2 vaccine.
The Native Antigen Company was one of the first recognised suppliers of SARS-CoV-2 antigens in February 2020, demonstrating their ability to rapidly support the diagnostic and vaccine industries with high-quality infectious disease reagents.
OXGENE’s Protein Machine Technology allows for the scalable production of viral proteins in mammalian cells using their proprietary adenoviral expression vector. Through genetic modification, the adenovirus is ‘tricked’ into making SARS-CoV-2 proteins rather than its own, thereby harnessing the innate power of highly scalable viral protein production.
Commenting on the collaboration, Dr Ryan Cawood, Chief Executive, OXGENE, said: “Our novel Protein Machine Technology represents a significant development in the rapid and scalable generation of high-quality viral proteins. We’re delighted that by collaborating with The Native Antigen Company, we can take advantage of our technology to support the needs of researchers racing to develop much-needed diagnostics and vaccines against COVID-19.”
The Native Antigen Company’s recombinant SARS-CoV-2 antigens are produced in mammalian cells to ensure full glycosylation and proper protein folding, both of which are essential for full biological and antigenic activity. The rapid scale up production of SARS-CoV-2 antigens is critical for the development of widely available diagnostic tests.
Dr Andy Lane, Commercial Director, The Native Antigen Company, said: “We are committed to developing the highest-quality reagents in rapid response to emerging epidemic diseases. Since the start of the crisis, the demand for our COVID-19 antigens has increased significantly, and by scaling up production of these vital reagents in collaboration with OXGENE, we hope to be able to support more researchers in their critical work developing diagnostics and vaccines.”
This collaboration builds on a long-standing collegiate relationship between the two Oxford-based businesses as they work towards developing more scalable technologies for the diagnosis of disease, and the cost-effective manufacture of high-quality diagnostics and vaccines.
OXGENE and The Native Antigen Company aim to complete the first validation of this new paradigm in protein expression by May 2020, which could have a demonstrable impact on the race to develop diagnostic kits and vaccines against this virus.
For further information about The Native Antigen Company’s Coronavirus Antigens, visit: https://thenativeantigencompany.com/coronavirus-dashboard/
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Using whole-genome sequencing for early identification and containment of AMR pathogens
, /in E-News /by 3wmediaA recently published study examines the evolutionary and epidemiologic history of an epidemic strain of extensively drug-resistant tuberculosis (XDR-TB) – called LAM4/KZN – in KwaZulu-Natal, South Africa. This strain was first reported in a 2005 outbreak in Tugela Ferry, KwaZulu-Natal, where it was associated with 90 % mortality among predominantly HIV infected individuals, and has since become widespread throughout the province. A new study identifies key host, pathogen and environmental factors that facilitated the success of this XDR-TB strain and steps that can be taken for early identification and containment of future epidemics.
The study, led by Columbia University, involved a multi-institutional team of researchers from South Africa, the United States, and Norway, used genomic, spatial and protein modelling to answer when and where this strain emerged, and how and why it became widespread. The study utilized data and TB strains collected in the prospective XDR-TB transmission study (TRAX) from 2011 to 2014 led by Emory University, the University of KwaZulu-Natal, and the U.S. Centers for Disease Control and Prevention.
Researchers localized the geographic origin of the strain to a rural district, bordering Mozambique and eSwatini, with high pre-existing rates of drug-resistant TB located 400 hundred kilometres away from where the first outbreak of LAM4/KZN was reported. Results also indicate that the strain emerged in the early 1990s, acquiring key advantageous mutations prior to undergoing marked expansion concurrent with the onset of the generalized HIV epidemic. In addition, the study suggests cyclical rural-urban migration in the rapid and widespread dissemination of this strain.
"Our results indicate that this strain of XDR-TB emerged approximately 12 years before it was identified by public health activities," said lead researcher Barun Mathema, PhD, assistant professor of epidemiology at Columbia University Mailman School of Public Health. "Our research highlights multiple environmental and pathogen-specific factors must align in order for these pathogens to establish sustained transmission and disperse into geographically separated populations. These processes take place in the so-called ‘pre-detection’ period, years before the pathogens are first noticed as public health threats," said Mathema.
"From our findings, we learned the importance of HIV coinfection, high pre-existing rates of drug-resistant TB, human migration, and adaptive evolution in the emergence and dispersal of this critical public health threat," noted first author Tyler S. Brown, MD, research fellow in the Infectious Diseases Division at Massachusetts General Hosptial.
"Routine integration of whole-genome sequencing into public health surveillance can address any knowledge gaps and enable us to better understand the pre-detection period and inform strategies for early identification and local containment of AMR pathogens," observed Mathema. "Surveillance, enabled by the rapidly decreasing cost of pathogen sequencing, can provide a powerful strategy for public health practitioners."
ScienceDaily
www.sciencedaily.com/releases/2019/10/191028175153.htmGrey Wolf Therapeutics completes £2.5 million financing to accelerate development of therapies targeting ERAP2
, /in E-News /by 3wmediaGrey Wolf Therapeutics, a drug discovery biotechnology company focused on developing first-in-class therapies for immuno- oncology (IO), has completed a £2.5 million ($3.3 million) Series A2 financing round with existing healthcare investors Andera Partners and Canaan.
The new funding will allow the company to accelerate development of therapies targeting endoplasmic reticulum aminopeptidase 2 (ERAP2), following many positive signals of its potential. Funds will also be used to continue to drive the lead endoplasmic reticulum aminopeptidase 1 (ERAP1) modulator program.
Both of Grey Wolf’s novel ERAP approaches are aimed at directly altering tumour cells, illuminating them for attack and destruction by the immune system. The goal is to exploit this increased tumour visibility in monotherapy and to extend the therapeutic benefit of already approved immunotherapies to many more cancers. The company is developing small molecule modulators of ERAP1 and ERAP2, two key proteins in the antigen presentation pathway, to change the antigen repertoire of tumours and thereby increase the number and range of cancer-related antigens, including neoantigens, presented on tumour cells available to engage an immune response. Grey Wolf is expanding efforts around ERAP2 for two reasons. First, clinical data continues to demonstrate that tumours which are more visible to the immune system show improved responses to checkpoint inhibitors. Second, the company has developed unique insight into the targeting of the ERAP enzymes through the lead program ERAP1 and validated the role for ERAP inhibition in modulating the cancer-related antigen repertoire.
“We have continued to generate data showing that modulation of both ERAP pathways drives change to the cancer-related antigen repertoire,” said Tom McCarthy, Executive Chairman and Co-Founder of Grey Wolf Therapeutics. “Data clearly demonstrates that modulation of ERAP2 drives an altogether different change to the antigen repertoire, when compared with ERAP1 modulation, due to ERAP2’s clearly differentiated peptide substrate specificities. With this investment and the prior knowledge base within Grey Wolf we will be able to accelerate the ERAP2 program quickly through optimization, building on our leading position in ERAP disease-related biology.”
Beckman Coulter partners with South West London Pathology to reduce the impact of sepsis
, /in E-News /by 3wmediaThe clinical diagnostics, company Beckman Coulter has implemented DxH 900 haematology analysers and the Early Sepsis Indicator across the South West London Pathology (SWLP) network. SWLP is an award-winning NHS pathology partnership set up by St. George’s University Hospitals NHS Foundation Trust, Croydon Health Services NHS Trust and Kingston Hospital NHS Foundation Trust. The installation enables SWLP laboratories to provide a single, integrated pathology service to more than 3.5 million people across South West London via three hospitals, 200 GP practices and 30 community healthcare sites.
Beckman Coulter’s DxH 900 haematology analysers enable clinical laboratories like SWLP to perform complete blood count and white blood cell differential tests. Demonstrating an industry-leading 93% first-pass yield, the DxH 900 reduces the number of manual slide reviews, helping to generate reportable results as quickly as possible. In addition, the DxH 900 features the Early Sepsis Indicator, the only CE marked and FDA-cleared haematologic biomarker that aids the diagnosis of sepsis in adult patients.
Commenting on the implementation, Simon Brewer, Managing Director at South West London Pathology, said: “Emergency departments across our network see 370,000 patients a year. And, with conditions like sepsis becoming more and more prevalent, it is mission critical to have the tools and technology to identify, diagnose, and begin treatment as early as possible.”
Life science start-up report reveals boom in new life science ventures
, /in E-News /by 3wmediaBioCity, a life science incubator and business collective has released its biennial publication, the UK Life Science Start-Up Report, an in-depth analysis of emerging businesses within the life sciences across the UK.
The report looks at the prevalence of life science start-ups in the UK over the past five years and the broader landscape in which they operate to also asses the quality of UK life science start-ups.
The report documents an unprecedented period of growth for the life sciences, thanks in part to a change in the funding landscape, expressed in a four-fold increase to £2.8 billion of investment in early-stage ventures, compared to the previous five-year period.
Multiple factors are highlighted as driving this expansion, but of greatest impact was Industry news January 2020 11 | the emergence of a number of significant venture funds able and willing to make very large investments in early stage businesses. Also identified as a contributing factor is the increasing use of smaller companies and academia as sources of innovation by large pharma companies aiming to counteract falling R&D productivity. Simultaneously, many universities such as Bristol, Newcastle and Aberdeen introduced a gear change in spin-out formation.
Author of the report, Dr Glenn Crocker said: “Both the number of companies starting up and the amount invested in them has taken off. We have seen a 50% increase in the number of companies and a four-fold increase in investment going into them; this will likely result in a substantial increase in the demand for space. We estimate that this cohort of businesses alone could require 1.4 million sq ft of specialist facilities over the next five years. One consequence of this demand growth is that real estate investors are being increasingly attracted to the sector.”
AI can be used to detect and grade prostate cancer
, /in E-News /by 3wmediaResearchers at Karolinska Institutet have developed a method based on artificial intelligence for histopathological diagnosis and grading of prostate cancer. The AI-system has the potential to solve one of the bottlenecks in today’s prostate cancer histopathology by providing more accurate diagnosis and better treatment decisions. The study shows that the AI-system is as good at identifying and grading prostate cancer as world-leading uro-pathologists.
“Our results show that it is possible to train an AI-system to detect and grade prostate cancer on the same level as leading experts,” says Martin Eklund, associate professor at the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet who led the study. “This has the potential to significantly reduce the workload of uro-pathologists and allow them to focus on the most difficult cases.”
A problem in today’s prostate pathology is that there is a certain degree of subjectivity in the assessments of the biopsies. Different pathologists can reach different conclusions even though they are studying the same samples. This leads to a clinical problem where the doctors must pick treatment based on ambiguous information. In this context, the researchers see significant potential to use the AI-technology to increase the reproducibility of the pathological assessments.
To train and test the AI system, the researchers digitized more than 8000 biopsies taken from some 1200 Swedish men in the ages of 50–69 to high-resolution images using digital pathology scanners. About 6,600 of the samples were used to train the AI system to spot the difference between biopsies with or without cancer. The remaining samples, and additional sets of samples collected from other labs, were used to test the AI system. Its results were also compared against the assessments of 23 world-leading uro-pathologists. The study was conducted in collaboration with researchers at Tampere University in Finland.
The findings showed that the AI-system was almost near-perfect in determining whether a sample contained cancer or not, as well as in estimating the length of the cancer tumour in the biopsy. When it comes to determining the severity of the prostate cancer, the so-called Gleason score, the AI system was on par with the international experts.
“When it comes to grading the severity of the prostate cancer, the AI is in the same range as international experts, which is very impressive, and when it comes to diagnostics, to determine whether or not it is cancer, the AI is simply outstanding,” says Lars Egevad, professor in pathology at Karolinska Institutet and co-author of the study.
The initial findings are promising but more validation is needed before the AI system may be rolled out broadly in clinical practice, according to the researchers. That is why a multicenter study spanning nine European countries is currently underway with completion slated by the end of 2020. That study, which is financed by EIT Health, aims to train the AI-system to recognize cancer in biopsies taken from different laboratories, with different types of digital scanners and with very rare growth patterns. In addition, a randomized study starting in 2020 will examine how the AI-model may be implemented in Sweden’s health care system.
“AI-based evaluation of prostate cancer biopsies could revolutionize future health care,” says Henrik Grönberg, professor in cancer epidemiology at Karolinska Institutet and head of the Prostate Cancer Center at St Göran Hospital in Stockholm. “It has the potential to improve the diagnostic quality, and thereby secure a more equitable care at a lower cost.” Karolinska Institute
Johnson & Johnson aims to produce a billion doses of COVID-19 vaccine
, /in Corona News, E-News /by 3wmediaJohnson & Johnson has announced the selection of a lead COVID-19 vaccine candidate on which it expects to initiate human clinical studies by September at the latest with the first batches of the vaccine available for emergency use authorization in early 2021.
In addition, the company announced the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA).
Johnson & Johnson also said the company will rapidly scale up its manufacturing capacity with the goal of providing a global supply of more than one billion doses of the vaccine.
Through the new partnership, BARDA and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. The company says will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts.
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services.
Commenting on the initiative, Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson, said: “The world is facing an urgent public health crisis and we are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible. As the world’s largest healthcare company, we feel a deep responsibility to improve the health of people around the world every day. Johnson & Johnson is well positioned through our combination of scientific expertise, operational scale and financial strength to bring our resources in collaboration with others to accelerate the fight against this pandemic.”
The company’s expansion of its manufacturing capacity will include the establishment of new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries. The additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses of a safe and effective vaccine globally.
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said: “We are very pleased to have identified a lead vaccine candidate from the constructs we have been working on since January. We are moving on an accelerated timeline toward Phase 1 human clinical trials at the latest by September 2020 and, supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021.” In addition to the vaccine development efforts, BARDA and Johnson & Johnson have also expanded their partnership to accelerate Janssen’s ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. The company’s aim is to identify potential treatments against the novel coronavirus. Johnson & Johnson and BARDA are both providing funding as part of this partnership. These antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven), in Belgium.
UK consortium set to trial COVID-19 adenoviral vaccine candidate
, /in Corona News, E-News /by 3wmediaA research consortium led by the Jenner Institute, Oxford University is set to begin fast-tracked clinical trials for a COVID-19 vaccine.
The adenoviral vaccine candidate, ChAdOx1 nCov-19 (ChAdOx1) is one of five frontrunner vaccines in development around the world, and expected to be the UK’s first COVID-19 vaccine.
Developed at the Jenner Institute, ChAdOx1 is one of the most promising vaccine technologies for COVID-19 as it can generate a strong immune response from one dose.
Cobra Biologics (Cobra), an international CDMO for biologics and pharmaceuticals, issued a statement 31 March saying they had joined the consortium to assist with the rapid development scale-up and production of the vaccine.
The ChAdOx1 consortium includes the University of Oxford Jenner Institute, University of Oxford Clinical Biomanufacturing Facility, the Vaccines Manufacturing and Innovation Centre (VMIC), Advent Srl, Pall Life Sciences, Cobra Biologics and Halix BV.
The consortium is currently recruiting individuals from a range of ages in the UK to trial the vaccine’s efficacy, in April 2020 – a crucial step in the vaccine’s development. Cobra is actively planning for a fast set-up phase to facilitate the efficient production of a GMP working cell bank and then 200L GMP viral vaccine. The consortium partners expect to develop and manufacture the vaccine candidate in multiple batches, to support a 1 million dose scale batch size, by mid 2020.
For more information about the trial, visit: www.covid19vaccinetrial.co.uk
Siemens Healthineers awarded FDA approval for RAPIDPoint 500e Blood Gas Analyzer
, /in Corona News, E-News /by 3wmediaSiemens Healthineers’s latest critical care testing solution, the RAPIDPoint® 500e Blood Gas Analyzer, has received clearance from the U.S. FDA, and is now available in the U.S., Europe and countries requiring the CE mark. The analyser generates blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin results, which are used to diagnose and monitor critically ill patients in the intensive care unit, operating room, or emergency room.
The RAPIDPoint 500e Blood Gas Analyzer is an essential instrument supporting COVID-19 response efforts, where blood gas testing plays a critical role in managing infected patients and monitoring their respiratory distress. Routine blood gas testing is also performed when patients require mechanical ventilation. Arterial blood gas tests provide the status of a patient’s oxygenation levels and enable healthcare providers to determine whether adjustments to ventilator settings or other treatments are required.
“The RAPIDPoint 500e Blood Gas Analyzer has become a trusted instrument in Europe’s endeavour to combat COVID-19 and to help address an unprecedented demand for blood gas testing in affected respiratory patients,” said Christoph Pedain, Head of Point of Care Diagnostics, Siemens Healthineers.
“Point-of-care teams monitoring respiratory conditions in critical care settings need a blood gas testing solution that delivers fast, accurate results and increases workflow efficiencies. A safe operating environment amid growing concerns about cybersecurity threats in healthcare is also important.”
The analyser elevates confidence in patient results with Integri-sense Technology, a comprehensive series of automated functional checks designed to deliver accurate test results at the point-of-care. Additionally, the RAPIDPoint 500e Analyzer integrates seamlessly into hospital networks with the Siemens Healthineers Point of Care Ecosystem, which offers convenient, remote management of operators and devices located across multiple sites.
Commenting on the device, Dr. Daniel Martin, Royal Free Hospital, London, said: “As an ICU physician, I know that the values I am handed during an emergency allow me to confidently make life-saving decisions. The RAPIDPoint system is easy to use and allows me to not worry about the machine and focus my attention on my patients.”
PCR Biosystems scales up production to meet global demand for COVID-19 diagnostic test
, /in Corona News, E-News /by 3wmediaUK-based PCR Biosystems issued a statement 1 April saying they are continuing to scale up operations to ensure the critical enzyme mix for COVID-19 tests remain available to the UK and global healthcare systems as demand for testing rises.
To meet current and upcoming requirements and ensure supply chain security, PCR Biosystems has already significantly increased – and will continue to increase – manufacture of qPCRBIO Probe 1-Step Go and all other critical reagents for rapid and sensitive RT-qPCR, the company said.
The company noted it has capacity to manufacture enough reagent daily for 4 million reactions – which is sufficient for millions of diagnostic tests.
qPCRBIO Probe 1-Step Go is a universal probe kit designed for fast and sensitive probe-based RT-qPCR. It is PCR Biosystems’s recommended product for COVID-19 diagnostic tests, supporting the detection, quantification and typing of the SARS-CoV-2 virus. All that’s required is the addition of specific primers and probes, together with the swab extract and water. qPCRBIO Probe 1-Step Go is compatible with all qPCR instruments and is engineered for use on a wide range of probe technologies including TaqMan®, Scorpions® and molecular beacon probes. In March 2020, PCR Biosystems introduced bulk pack sizes of this key product, to further support customers in high-throughput COVID-19 testing.
Alex Wilson, Co-Founder of PCR Biosystems, explained: “These are unprecedented times, and, as a global PCR company, we are ideally placed to support the scientific and healthcare communities in their response to COVID-19. When the enormity of COVID-19 testing requirements became apparent, we immediately started scaling up production of the critical components. We already have capacity to supply 4 million reactions’ worth of reagent every day – and we have the option to scale up further if needed to ensure we can always meet global demand.”
For more information on PCR Biosystems’s reagents, visit: www.pcrbio.com
Oxford-based businesses collaborate to scale up production of SARS-CoV-2 antigens
, /in Corona News, E-News /by 3wmediaOXGENE and The Native Antigen Company are collaborating to scale up production of SARS-CoV-2 reagents by combining OXGENE’s proprietary Adenoviral Protein Machine Technology with The Native Antigen Company’s antigen development expertise. Together, they aim to scale their antigen manufacturing capabilities to deliver high-purity, recombinant proteins for the development of diagnostics and vaccines.
Unlike the PCR tests that are currently being used, these diagnostics will be able to confirm past infections and determine levels of immunity to SARS-CoV-2. This could be invaluable for disease modelling and public health policy, as true transmission rates and case fatality rates can be determined. These tests could also be instrumental for the diagnosis of healthcare workers who have been exposed to the virus to ensure that they have developed natural immunity before returning to work, and to help measure patient immune responses for the rapid development of a SARS-CoV-2 vaccine.
The Native Antigen Company was one of the first recognised suppliers of SARS-CoV-2 antigens in February 2020, demonstrating their ability to rapidly support the diagnostic and vaccine industries with high-quality infectious disease reagents.
OXGENE’s Protein Machine Technology allows for the scalable production of viral proteins in mammalian cells using their proprietary adenoviral expression vector. Through genetic modification, the adenovirus is ‘tricked’ into making SARS-CoV-2 proteins rather than its own, thereby harnessing the innate power of highly scalable viral protein production.
Commenting on the collaboration, Dr Ryan Cawood, Chief Executive, OXGENE, said: “Our novel Protein Machine Technology represents a significant development in the rapid and scalable generation of high-quality viral proteins. We’re delighted that by collaborating with The Native Antigen Company, we can take advantage of our technology to support the needs of researchers racing to develop much-needed diagnostics and vaccines against COVID-19.”
The Native Antigen Company’s recombinant SARS-CoV-2 antigens are produced in mammalian cells to ensure full glycosylation and proper protein folding, both of which are essential for full biological and antigenic activity. The rapid scale up production of SARS-CoV-2 antigens is critical for the development of widely available diagnostic tests.
Dr Andy Lane, Commercial Director, The Native Antigen Company, said: “We are committed to developing the highest-quality reagents in rapid response to emerging epidemic diseases. Since the start of the crisis, the demand for our COVID-19 antigens has increased significantly, and by scaling up production of these vital reagents in collaboration with OXGENE, we hope to be able to support more researchers in their critical work developing diagnostics and vaccines.”
This collaboration builds on a long-standing collegiate relationship between the two Oxford-based businesses as they work towards developing more scalable technologies for the diagnosis of disease, and the cost-effective manufacture of high-quality diagnostics and vaccines.
OXGENE and The Native Antigen Company aim to complete the first validation of this new paradigm in protein expression by May 2020, which could have a demonstrable impact on the race to develop diagnostic kits and vaccines against this virus.
For further information about The Native Antigen Company’s Coronavirus Antigens, visit: https://thenativeantigencompany.com/coronavirus-dashboard/